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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
Come join our high-energy Sustaining team in Kingston ON as we strive to improve reliability and customer experience of a novel cell manufacturing equipment platform. The Cocoon® platform is an automated, scalable, and functionally closed-process cell therapy manufacturing platform.
It is used to manufacture multiple types of cell therapy with applications in oncology (i.e.
CAR-T). Learn more here and here.
The Product Support Engineer will be an integral part of the Sustaining Engineering team, which is focused on sustaining and improving the design of our products through the product life-cycle. The successful candidate will be responsible for triaging product opportunities that are encountered pre-release (during manufacturing), and post-release (with customers, both externally and internally ).
The Product Support Engineer will be required to have a deep understanding of the opportunities such that they can gather important information and facilitate root cause analysis in a cross functional team environment.
Our products include complex integrated systems, and this role will operate at the intersection of many disciplines, including electrical, mechanical, software, and even biology.
Lonza offers a hybrid work policy to best balance work responsibilities.
Responsibilities:
* Respond to challenges identified by product users related to product design
* Methodical troubleshooting using run data and software logs (run queries and debug), measurement techniques and designing further experiments as required
* Tenacity in identifying the root cause of highly integrated and complex issues
* Recommendation for Corrective and Preventative actions to improve product design
* Document technical pursuits and experiments as necessary within the Quality Management System
* Contribute to growing knowledge base of circumstances encountered by users
Requirements:
* Bachelor’s degree in an engineering discipline such as Electrical, Systems, Software, Computer, Mechatronics or similar path of study;
* Ability to read and understand software code and software logs and databases
* Experience in a technical support/ quality managed environment; medical device experience a plus
* Integrated systems experience, a plus
* Ability to gather, systemize and analyze data
* Highly adaptable in environment with changing demands, deadlines and priorities
* Clear and thorough documentation skills
Every day, Lonza’s products and services have a positive imp...
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Type: Permanent Location: Kingston, CA-ON
Salary / Rate: Not Specified
Posted: 2023-01-29 06:55:19
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At Milk Specialties Global, our focus is to create high-quality ingredients designed to optimize health and nutrition.
We are passionate and dedicated people.
Each day, we collectively explore new, innovative ways to enhance product performance and value through our broad human and animal nutrition portfolios. We offer a comprehensive benefits package which includes medical, dental, vision and life insurance as well as a healthy 401(k) company match program.
The Caseinate Plant Manager is responsible for the product safety, quality and regulatory compliance for the Sodium Caseinate department.
This includes but is not limited to developing sanitation procedures, production goals, safety procedures, SOP creation and implementation.
Essential Functions:
* As part of the leadership team help drive culture change by leading as example with positive attitude and innovative thinking to contribute to the business strategy.
* Coordinate activities of all manufacturing functional areas to assure continuity towards plant goals, communicating priorities as necessary.
Develop SOP’s for all production processes.
* Recruit, develop, coach, lead and motivate personnel, constantly raising the standards of performance.
Develop and improve technical and manufacturing management skills at the plant.
* Lead and supervise all production personnel in functional areas constantly raising the standard of performance.
Establish education and development programs for employees including SOP’s, quality specifications, safety and job expectations.
* Work with Operators to organize and maximize inclusion of all raw materials and rework to be utilized in production process.
* Ensure that physical characteristics are monitored hourly.
Evaluate products for specs, grits, flavor, density, mix abilities and moisture, ensuring finished product meets all quality specifications.
* Implement and enforce safety and regulatory programs to ensure long term safe operation of the facility.
* Ensure inventory accuracy and timely completion of all shift reports including Inventory levels as the plants KPI matrix.
Coordinate all record keeping with Production Manager such as production, quality assurance, inventory control, production planning and administrative personnel.
* Ensure compliance with all company, state, federal and international safety and regulatory policies and practices as appropriate.
* Establish appropriate scheduling and employee work schedules in line with customer orders and plant performance requirements.
* Work with Quality/ R&D develop new products/processes and improve current products/processes.
Establish procedures and supervise all experimental and test runs, reporting all results.
* Work with QA to release product according to specifications.
* Assist with GMP and HACCP education of the employees.
* Maintain FDA compliance, HACCP and GMP programs.
* Manage inventory of off-spe...
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Type: Permanent Location: Norfolk, US-NE
Salary / Rate: Not Specified
Posted: 2023-01-29 06:55:05
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The Actuarial Director will support within the regulated Medicare market and Pharmacy Benefit Manager (PBM) Healthplan space.
This is an exciting opportunity to build out your own team and support a large client!
The Actuarial Strategy role is designed to provide a designated full-time support to Express-Script's external client Centene's Medicare Part D business.
This role will matrix with internal leadership within trend, formulary, clinical, knowledge solutions, sales & account management, and supply teams.
The role will involve leading development of actuarial analyses for Medicare Part D business, including but not limited to; special CMS programs, drug expense analyses and projections, financial forecasts, actuarial modeling, pharmacy network optimization strategies, manufacturer rebates optimization, regulatory impact assessment, and ad hoc actuarial analyses as needed.
What else will you be doing in this role?
Product Support / Development
* Lead development of Actuarial analytics products for Express Scripts existing and new Medicare Part D Plans
* Perform financial analyses of proposed regulatory changes, demonstration programs, and other special programs by CMS to determine financial impact on various entities within the drug supply chain
* Develop actuarial models to aid in prospective projections of Medicare Part D Plan client's plan liability and premium impact sensitivities
* Build actuarial models and project management functions to accelerate and safeguard improvements in the development of analytics tools to identify gaps in the Medicare Part D market
* Lead studies to aid in identification of gaps in the Medicare Part D Prescription Drug Health market to aid in development of strategies to help close identified gaps
Analytics Support to Centene Part D Plans
* Drive strategic discussion to develop analytics road map to optimize Part-D revenue optimization and cost-reduction strategies for Medicare Part D Health Plans: PDP, MAPD, and Special Needs Program (SNPs)
* Lead development of actuarial formulary analyses to aid in development of custom Medicare formulary designs
* Utilize independent judgement and discretion to perform complex customized actuarial analyses for Part D Health Plans
Cross-Functional Financial Support
* Collaborate with internal Express-Scripts business partners and external vendors to determine operation feasibility and financial ramifications of special programs
* Apply distinct Part D subject matter expertise (SME) to facilitate analytics capabilities, measure performance and aid in problem solving, and creation of actionable insights for technical teams within Express-Scripts enterprise
* Cross-functional collaboration within Express-Scripts enterprise Medicare Part D financial and operational strategy development.
Quantification of impact of regulatory proposals and changes
Regulated Part D Health Plan Financial Reconciliation Support
* A...
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Type: Permanent Location: Bloomfield, US-CT
Salary / Rate: Not Specified
Posted: 2023-01-28 07:15:49
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Imaging Specialist
Access is currently seeking a scanning specialist for our Miami location, this position will be responsible for performing the document preparation and scanning task of importing client documents.
You will be responsible for the following:
• Prepare, index, and scan all hard copy records according to specific client requests.
• Upload all documents scanned on third-party software.
• Perform quality checks on all documents scanned, detect image errors and determine the cause of the errors.
• Manual data entry of required fields for validation and verification.
Requirements:
• The physical ability to lift boxes and materials weighing up to 50 pounds.
• Must be able to pass a pre-employment substance abuse screening and a background check.
*
*
*
*Since the beginning of the Covid-19 pandemic, many client contractual requirements, whether Federal, State, or private, require that Access Team Members be fully vaccinated in order to service those client accounts. Accordingly, Access requires that all new team members be fully vaccinated.
Why Access?
* Monday – Friday Schedule competitive hourly rate
* Medical, Dental, Vision and Life insurance
* 14 days of PTO, 8 paid holidays, plus 2 personal days
* 401K Retirement program with 3% company match, 100% vesting in 2 years
* Company Paid Uniforms
* Training and Growth Opportunities
All qualified applicants will receive consideration for employment.
EEO/AA/Minorities/Females
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
41 CFR 60-1.35(c)
Imaging
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Type: Permanent Location: Miami, US-FL
Salary / Rate: Not Specified
Posted: 2023-01-28 07:09:40
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The Food Science Intern assists the Research and Development team with new product development, optimization, and ingredient functionality of retail and food service ingredients and finished products.
This position will provide the opportunity to experience food product research activities in a corporate setting with exposure to production plant facilities.
Essential Functions: Other duties, responsibilities, and activities may change or be assigned at any time.
* Participates in product development and commercialization process and develops an understanding of ingredient technology and function.
* Prepares and evaluates consumer baking mixes, coatings, beverages, sauces, and snacks.
+ 80% Hands-on research and development.
+ 20% Data processing.
* Responsible for conducting, leading, and executing research project to be presented to the company at the end of the intern period.
* Prepare and lead a short course with literature to be shared with the R&D team on a topic relevant to the food industry as it applies to The Krusteaz Company.
* Performs other duties and project teams as assigned.
Position Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions.
Communication:
* Strong written, oral, and facilitation skills.
* Excellent listener.
* Ability to ask questions and act upon the information presented.
Technical Capability:
* Working knowledge of scientific techniques and standard lab equipment.
* Strong desktop applications competence (Excel, Access, Word).
* Keen attention to detail.
* Problem solving skills and ability.
Personal and Social Competence:
* High integrity and honesty, promoting trust in all actions.
* Discretion, professionalism, and ability to hold confidential information.
* Strong work ethic w/ a desire to learn.
* Flexible, and adaptive with the ability to handle changing timelines and priorities.
* Timeline oriented.
* Ability to work both independently and in a team environment.
* Ability to work in a food laboratory and manufacturing environment.
* Ability to stand, bend, and lift product (up to 40 lbs.).
Education and/or Experience:
* Completion of Junior year and currently working towards a B.S.
or M.S in Food Science or related field.
* 1 year of Chemistry – Food Chemistry Fundamentals preferred.
* Food Safety and Sanitation Coursework required.
* Must be 18 years of age and legal to work without sponsorship in the United States.
The policy of The Krusteaz Company is to hire, train, and promote all persons in all job groups in accordance with law, without regard to race, color, religion,...
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Type: Permanent Location: Tukwila, US-WA
Salary / Rate: Not Specified
Posted: 2023-01-28 07:05:55
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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
The QC Analyst will act as a team member of the Quality Control scientist group to support bioburden qualification of existing and new customer samples as well as raw materials.
The QC Analyst should be able to provide on-time, high quality results to meet Manufacturing demands.
Applies job skills and company's policies and procedures to complete a variety of tasks.
Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
*The work schedule for this position is Sunday-Wednesday 7AM- 5:30PM
*
Key Responsibilities:
* Running test samples for bioburden qualification
* Reviewing assays
* Writing and executing protocols and reports
* Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
* Perform other duties as assigned
* Level of this role is dependent on experience
Key Requirements:
* Bachelor or Associates Degree required in Microbiology, Biochemistry or Related Science field
* 3+ years of experience with bioburden
* 3+ years of industry experience in a GMP/cGMP environment
* Use of Microsoft Suites (Word, Excel, Powerpoint)
* Use of Laboratory computer systems (LIMS) and TrackWise preferred
* Solid ability to interpret data
* Prioritization and problem solving
* Solid ability to communicate in both written and verbal format
* Displays commitment to quality and performs job functions to the best of her/his ability
Every day, Lonza’s products and services have a positive impact on millions of people.
For us, this is not only a great privilege, but also a great responsibility.
How we achieve our business results is just as important as the achievements themselves.
At Lonza, we respect and protect our people and our environment.
Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
In return, we offer the satisfaction that comes with improving lives all around the world.
The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status a...
....Read more...
Type: Permanent Location: Portsmouth, US-NH
Salary / Rate: Not Specified
Posted: 2023-01-28 07:05:22
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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
The QC Analyst will act as a team member of the Quality Control scientist group to support bioburden qualification of existing and new customer samples as well as raw materials.
The QC Analyst should be able to provide on-time, high quality results to meet Manufacturing demands.
Applies job skills and company's policies and procedures to complete a variety of tasks.
Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
*The work schedule for this position is Wednesday-Saturday 7AM- 5:30PM
*
Key Responsibilities:
* Running test samples for bioburden qualification
* Reviewing assays
* Writing and executing protocols and reports
* Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
* Perform other duties as assigned
* Level of this role is dependent on experience
Key Requirements:
* Bachelor or Associates Degree required in Microbiology, Biochemistry or Related Science field
* 2+ years of experience with bioburden
* 2+ years of industry experience in a GMP/cGMP environment
* Use of Microsoft Suites (Word, Excel, Powerpoint)
* Use of Laboratory computer systems (LIMS) and TrackWise preferred
* Solid ability to interpret data
* Prioritization and problem solving
* Solid ability to communicate in both written and verbal format
* Displays commitment to quality and performs job functions to the best of her/his ability
Every day, Lonza’s products and services have a positive impact on millions of people.
For us, this is not only a great privilege, but also a great responsibility.
How we achieve our business results is just as important as the achievements themselves.
At Lonza, we respect and protect our people and our environment.
Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
In return, we offer the satisfaction that comes with improving lives all around the world.
The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, statu...
....Read more...
Type: Permanent Location: Portsmouth, US-NH
Salary / Rate: Not Specified
Posted: 2023-01-28 07:05:14
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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
Lonza in Portsmouth, NH is searching for a QC Microbiology Supervisor to join our QC team.
As our QC Microbiology Supervisor, you will be responsible for ensuring and providing a safe work environment to the staff in the execution of their work duties.
You will also be expected to create a culture of disciplined execution and a high level of professionalism for their team while remaining focused on product quality and patient safety.
*The work schedule for this position is for M-F 8AM-5PM
*
Key Responsibilities:
* Scheduling and planning of routine testing
* Assay/Documentation/Quality System Review
* Quality writing including deviations, SOPs, CAPAs, change controls
* Attending department related meetings
* Independently drive projects to on-time completion
* Oversee a team of direct reports, including resolving conflicts and training
* Troubleshooting, problem solving issues
* Oversees the routine bioburden, endotoxin, TOC, and BI, as well as stability, BDS, and audit support
Key Requirements:
* Bachelor or Advanced Graduate Degree.
Preferred area of study in Microbiology, Biochemistry or Related Science Fields.
* 7+ years or subject matter expert level knowledge of the following tests: bioburden, endotoxin, TOC
* Significant experience working within the biotechnology industry.
* Preferred experience in a direct supervisory role, previous leadership experience required
* Strong knowledge Quality writing- deviations, SOPs, CAPAs, change controls
* Previous experience using GMP Electronic Systems (ex.
TrackWise, LIMS, iLAB, MODA).
* Excellent communication skills with the ability to collaborate across multiple teams and projects.
* Experience with speaking publicly.
Able to maintain control of meetings as required.
* Previous experience working in a customer facing role preferred
Every day, Lonza's products and services have a positive impact on millions of people.
For us, this is not only a great privilege, but also a great responsibility.
How we achieve our business results is just as important as the achievements themselves.
At Lonza, we respect and protect our people and our environment.
Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
In return, we offer the satisfaction that comes with improving lives all around the world.
The satisfaction that comes with making a meaningf...
....Read more...
Type: Permanent Location: Portsmouth, US-NH
Salary / Rate: Not Specified
Posted: 2023-01-28 07:05:08
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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
The Sr QC Analyst is responsible for performing routine and specialized analytical/compendia testing of raw materials in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
The individual is also responsible for working in a team atmosphere and meeting the needs of internal, as well as external, customers.
*The schedule for this position is Sunday-Wednesday 7AM-5:30PM
*
Key Responsibilities:
* Performs routine and specialized raw material testing (including IR/Raman spectroscopy, wet chemistry analysis, titrations, HPLC and GC) according to Standard Operating Procedures and Pharmacopeia methods, in compliance with cGMP.
* Participates in method transfer/qualification/verification of test methods, new instruments, method qualifications
* May prepare sample shipments and submission paperwork for contract laboratory testing. Reviews data received from contract lab for cGMP compliance in LIMS system.
* Records, analyzes, and reviews all data related to testing.
Performs project related tasks as assigned with general instructions.
* Leads and writes OOS (Out of Specification) /deviation investigations, change controls and CAPA.
* Writes/revises Standard Operating Procedures (SOPs), validation/qualification/verification protocols and reports for test methods.
* Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies. Maintains compliance with all required training.
* Trains other analysts.
Key Requirements:
* Associates or Bachelors degree required, in Chemistry or Related Science Fields preferred.
* 5+ years of experience within GMP/cGMP industry in a Quality environment
* Preferred experience testing to international regulatory standards for pharmaceuticals/biologics
Every day, Lonza's products and services have a positive impact on millions of people.
For us, this is not only a great privilege, but also a great responsibility.
How we achieve our business results is just as important as the achievements themselves.
At Lonza, we respect and protect our people and our environment.
Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
In return, we offer the satisfaction that comes with improving lives all around the world.
The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportuni...
....Read more...
Type: Permanent Location: Portsmouth, US-NH
Salary / Rate: Not Specified
Posted: 2023-01-28 07:05:06
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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
The QC Supervisor will act as a lead team member of the Quality Control department to support sampling and testing of the site's controlled production areas and GMP utilities. Organizes and plans QC sampling, qualification and release for ongoing operational needs. Provides on-time, high quality results to meet Manufacturing demands.
*This position is 2nd shift role that reports to work Monday-Friday 3PM-11PM
*
Training will be conducted during the day shift for a few weeks
While working 2nd shift, the employee will receive a 10% shift differential
Key Responsibilities:
* Scheduling, planning and assurance of on-time delivery of routine sampling in compliance with all cGMP and regulatory requirements. Ensures a safe work environment for employees to perform their duties.
* Creating, reviewing and approving QC documentation.
* Schedules and attends department and site related meetings to assure delivery, adherence to quality systems, continuous improvement and customer satisfaction
* Drives all projects to on-time completion be ensuring task completion and communicating potential issues to stakeholders. Troubleshooting and resolving these issues through team efforts
* Resolving personnel issues and workplace conflicts. Establishing a cohesive team environment that focuses on achieving corporate goals and right first time initiatives
* Leading OE initiatives, continuous improvements, implementation of new processes and procedures to support site and corporate growth, hiring and mentoring of staff, supports regulatory and customer audits, creates and executes CAPA plans.
* Perform other duties as assigned.
Key Requirements:
* Bachelor’s Degree required; preferred area of study in a science related field
* Use of Microsoft Suites (Word, Excel, Powerpoint)
* Experience in applicable laboratory software and hardware systems
* Previous experience in leadership or supervisory positions
* Use of GMP Quality Systems such as: TrackWise, LIMS, DMS, Electronic note book
* Intermediate understanding of cleanroom design and controls, and cleanroom utilities
* Perform assigned, complex and/or varied tasks
* Excellent ability to prioritize work load for group and problem solve
* Excellent ability to communicate in both written and verbal format
Every day, Lonza’s products and services have a positive impact on millions of people.
For us, this is not only a great privilege, but also a great responsibility.
How we achieve our busine...
....Read more...
Type: Permanent Location: Portsmouth, US-NH
Salary / Rate: Not Specified
Posted: 2023-01-28 07:04:53
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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
The QC Project Manager is assigned as the primary liaison to an external customer(s) for all QC related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews, and GMP Records.
Responsible to facilitate discussions between customers and internal groups such as QC, PV, MSAT, Manufacturing, Engineering and QA.
For these quality-related items, the Project Manager coordinates the process for notifying the customer and assuring the customer’s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale; supports root cause analysis and identification of corrective and preventive action.
Where applicable, the Program Manager assists in obtaining customer approval.
The QC Project Manager leads Analytical Project Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QC representative and tracks and publishes monthly and quarterly quality KPIs.
Must be within (or able to relocate to) commuting range of our Portsmouth NH facility, as regular on-site presence is required for this position
Key Responsibilities:
* Manages multiple complex customer project teams as the Quality Control representative.
* Delegates and manages action items to appropriate responsible parties.
* Interprets analytical reports and effectively communicates content to external and internal stakeholders.
Measures appropriate metrics and report them to management.
* Coordinates efforts between manufacturing, customer and Quality Control to assure that testing is prioritized, completed on time and communicated in an effective and timely manner.
* Creates, revises and reviews Good Manufacturing Practices (GMP) documentation, which includes specifications, protocols and reports.
* Review and approve various product specific documents such as batch records, sample plans, sample maps, etc.
* Collaborate and prioritize with QC leaders, other departments, and/or customers to create an achievable work schedule and to ensure agreed upon timelines are met.
* Interacts with internal and external customer as part of Joint and Internal project Teams serving as the QC Subject Matter Expert.
* Initiates and drives quality records, for example change controls, investigations, deviations, CAPAs, etc.
* Works independently to drive tasks to completion.
* Perfor...
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Type: Permanent Location: Portsmouth, US-NH
Salary / Rate: Not Specified
Posted: 2023-01-28 07:04:31
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Enabling critical work and rubbing shoulders with the scientists who are contributing to the impact of our world’s health – that’s what people in our Program Management group at FlowMetric get to do every day. If that gets you excited too, then maybe working as a Program Manager at FlowMetric is a role to consider.
When you work as a Program Manager at FlowMetric, you get to further our mission by driving the delivery, coordination, and management of client projects and programs.
The Program Manager will communicate with various team members including business development, lab operations, data management and finance to ensure harmonization of goals, and to proactively identify and remedy obstacles to success.
The Program Manager will also track KPIs, provide project updates and answer client questions.
Most importantly, your success will enable FlowMetric to continue to expand and meet its lofty goals.
In this role, we will rely on you to:
* Reports to Program Management Lead and supports Lab Operations with all administrative aspects of projects to meet agreed upon timelines.
* Engages with clients while having a strong grasp of business needs and project expectations through SOW review.
* Update project plans based on project scope and objectives.
* Ensures project trackers are up to date.
* Communicates with cross discipline team members, ensuring all parties are on track with project requirements
* Schedules and attends client calls, taking and distributing minutes with action items.
* Meet with project team members to identify and resolve issues.
* Manage customer satisfaction, reporting on any issues
* Perform lessons learned following project completion
* Coordinates with Business Development team and Lab Operations on amendments as needed
* All other duties as assigned
(This is a representative summary of responsibilities and is not meant to be exhaustive)
WHO YOU ARE:
You will thrive at FlowMetric if you enjoy a fast-paced environment, are open-minded and flexible, can prioritize effectively to solve problems and meet deadlines, embrace high-level performance and constant development, and are self-directed while being drawn to the camaraderie of a team atmosphere.
To qualify specifically for this role, you will have:
* Bachelor’s degree
* 1-3 years of experience in Life Sciences industry as a client facing program/project manager
* CAPM (Certified Associate in Project Management) certification beneficial but not required
* Experience with/understanding of GLP principles, able to write SOPs as needed
* Background in CRO or Biopharma a plus
* Demonstrated ability to communicate across functions successfully
* Capable of leading and executing internal process improvement efforts from end to end
* Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and Project.
WHAT YOU’LL GET:
Our benefits include, an...
....Read more...
Type: Permanent Location: Spring House, US-PA
Salary / Rate: Not Specified
Posted: 2023-01-28 07:04:10
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Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
We are actively recruiting candidates to participate in our 2023 On-site Summer Internship program.
This program is roughly 10 weeks in length and will immerse you into the culture and operations of Lonza Houston.
The Project Engineer Intern will lead in detailing the scope, timeline, and budget of projects approved for the 2023 F&E CAPEX plan.
The Project Engineer will work with several internal and external groups to effectively execute projects within the detailed timeframe and budget which in turn will create value for Lonza and its stakeholders.
The internship program begins Monday, June 5, 2023 and ends on Friday, August 11, 2023.
Potential interns must be able to commit to at least 40 hours per week throughout the duration of the summer internship.
Key Responsibilities
* Finalize scope, timeline, budget, approval of several 2023 targeted projects through the CAPEX process
* Assist in the execution of the 2023 Cleanroom WIFI upgrade project
* Create a site wide chilled water distribution flow & pressure model for the utilities department
* Work with external vendors/contractors and internal team members to execute project scopes, adhering the approved timelines and budgets.
* Provide assistance with the 2023 site CAPEX plan and help coordinate with other internal departments on equipment release and project completion
* Organize and help lead weekly project meetings for the Project Engineering department in order to help the department stay organized and provide monthly updates to the site leadership team.
Required Education/Training
* Minimum cumulative GPA of 3.0 (out of 4) required
* Must currently be enrolled in BS, MS, and PhD Academic Program
* Must be available for the entirety of the Internship duration from Monday, June 5, 2023 to Friday, August 11, 2023
* Must successfully complete and pass all pre-employment screenings prior to start of internship (after competition of background and drug screening)
Preferred Education/Training
* Completion of Junior or Senior year (typically 60-90 credits) towards a B.S.
degree in a related field, or graduate students enrolled in Masters or PhD Academic Programs
Internship Application Requirements
To be considered for our internship program, you must include the following documents with your application submission by Friday February 17th, 2023:
* Resume/CV
* Transcript
* One letter of recommendation from Professor
* Cover Letter describing how your current studies, interests, and f...
....Read more...
Type: Permanent Location: Houston, US-TX
Salary / Rate: Not Specified
Posted: 2023-01-28 07:03:57
-
The Test Technology Division of Applied Research Associates, Inc.
(ARA) has an exciting opportunity for a health and safety officer.
We are looking for an individual with at least 10 years of experience; a technical degree is preferred, but not required.
The successful applicant will work with our current health and safety officer and our safety committee to ensure safety compliance within our division, and over the test sites where ARA will be the controlling employer for safety.
We are a group of engineers, scientists and technicians supporting the government in various types of field testing.
Our work is mostly performed in New Mexico on Kirtland Air Force Base, White Sands Missile Range and at our ARA test site in Moriarty.
The candidate should be a team player who will help us continue to be safe and foster a safety environment ensuring all are protected.
Efforts shall be focused on ensuring ARA, subcontractors, and customers understand safety requirements, have the required training, and are following the safety requirements on the test beds.
This will be achieved through writing Health and Safety Plans (HASPs), Conducting Hazard Assessments, Standing Operating Procedures (SOPs), and documentation of training from all organizations involved on the test sites.
Exceptional written communication skills are required.
The successful applicant will have strong organization and documentation skill.
Experience with electrical and construction elements is required.
An individual with regulatory expertise and the ability to research, understand and apply regulations in diverse areas is required.
Candidate must be flexible and capable of determining the best safety methods for the job at hand so that work can be accomplished.
Candidate will be personable and able to work effectively with customers as well as our employees.
Candidate will be able coach and mentor others and help all understand the importance of safety protocols.
Candidate shall prepare and present safety materials to the existing safety officer’s standards as well as those of our various clients.
A hands-on attitude is required for this position.
Experience with government (DoD/DOE), military service regulations and working with subcontractors are a plus.
The applicant will be required to work with our customer and help resolve safety issues on a regular basis.
The ideal applicant will be responsible, energetic, detail oriented, able to organize and execute work independently, proactive in problem solving, flexible to meet changing requirements and service focused.
Integrity, initiative and dependability are a must.
The position supports a $15M/yr business unit with broad research, fabrication and field–test responsibilities.
Salary range is dependent on skill level.
Employment is contingent on obtaining a Security Clearance.
A current clearance is highly desirable.
Essential skills:
* Experience leading safety programs for a controlling employer
* Developing and up...
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Type: Permanent Location: Albuquerque, US-NM
Salary / Rate: Not Specified
Posted: 2023-01-28 07:03:24
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ARA is seeking a technical leader with National Science Foundation (NSF) experience and corresponding NSF portfolios/stakeholders.
ARA is an innovative science and technology company with expertise in a wide variety of research areas including biotechnology, artificial intelligence, and clean energy. ARA has particular expertise in helping translate innovative research and development into operational capabilities.
The NSF Technical/Business lead will identify and pursue new growth areas by leveraging ARA’s portfolio of research and development capabilities as well seeking/capturing new NSF projects; particular emphasis is developing close relationships with academic institutions to support the expanding NSF portfolio in Technology, Innovation, and Partnerships (TIP). To accomplish these goals, the successful candidate will lead the development of a long-range business plan and marketing strategy and will coordinate input from ARA business units and technical leads. The NSF lead will utilize their expertise and community network within the research community to project the future needs of the NSF and help ARA develop the skills and resources to meet those needs.
The successful candidate will have an advanced technical degree and at least ten years of experience in NSF related work in either commercial, government or academic settings.
As the NSF Technical/Business Development Manager, you will be a valued member of a team of passionate, service-focused professionals, located throughout North America.
What you’ll do as the NSF Technical Lead
* Develop a long-range business plan, including a detailed associated marketing/business plan, to expand ARA’s research and development portfolio
* Capture and interpret market intel (directly from customers and indirectly from publications, trade shows, and other sources) and share intel with others through regular communications and through entry into ARA’s customer resource management (CRM) system
* Develop and maintain business relationships within the NSF community senior government leaders as well as key academic partners
* Engage and interact with customers on a regular basis to understand their needs and plans and to describe how ARA technologies may help their efforts
* Assist with preparation/delivery of briefings to ARA senior leadership
* Collaborate with ARA subject matter experts to develop value propositions to customers
* Assist ARA business units with NSF marketing activities to ensure professional and compelling marketing/proposal offerings.
* Provide technical expertise and program management for key research projects.
Desired NSF Technical/Business Development Manager Qualifications
* Ph.
D.
degree or equivalent in physics, engineering, mathematics, chemistry, biology, or other hard science.
* Candidate should be published and well known in their field of study
* Demonstrated experience at NSF as PM or highe...
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Type: Permanent Location: alexandria, US-VA
Salary / Rate: 177100
Posted: 2023-01-28 07:03:23
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Scientist Method Validation R51271
Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
We are currently looking for a Scientist to join our Method Validation team based in Slough.
Working within our Method Validation team, you will be validating analytical methods and GMP testing biological products that are manufactured by Lonza.
Key responsibilities:
* Performing laboratory work, collating, analysing and interpreting data to communicate progress and escalate challenges to Line Manager and project teams.
* Supporting multiple studies by testing and potentially by study directing (transfer and or validation for a range of analytical methods)
* Leading troubleshooting/out of specification investigations and associated quality records as required
* Writing GMP documentation e.g.
protocols and reports
* Promote good scientific practice and process improvements in line with regulatory requirements. Coaching and/or mentoring junior scientists/technologists.
* Evaluating and driving new innovations to the Method validation department
Key requirements:
* BSc or Msc degree in life science or equivalent relevant field
* Experience in executing method validation studies (for identity or impurity) for any of these techniques: qPCR, ELISA, cell based assays, HPLC (RP, IEX, SEC), icIEF,
* Experience working within a GMP Environment is a must
* Highly motivated, and demonstrates commitment to team, and strong communication skills - you enjoy working hands-on in the laboratory
Every day, Lonza’s products and services have a positive impact on millions of people.
For us, this is not only a great privilege, but also a great responsibility.
How we achieve our business results is just as important as the achievements themselves.
At Lonza, we respect and protect our people and our environment.
Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
In return, we offer the satisfaction that comes with improving lives all around the world.
The satisfaction that comes with making a meaningful difference.
#LI-SW1
....Read more...
Type: Permanent Location: Slough, GB-ENG
Salary / Rate: Not Specified
Posted: 2023-01-28 07:02:45
-
Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
We are actively recruiting candidates to participate in our 2023 On-site Summer Internship program.
This program is roughly 10 weeks in length and will immerse you into the culture and operations of Lonza Houston.
The Analytical Development Intern provides technical support to lead scientists in conducting analytical tests for the evaluation of cellular products and in support of process development activities.
The internship program begins Monday, June 5, 2023 and ends on Friday, August 11, 2023.
Potential interns must be able to commit to at least 40 hours per week throughout the duration of the summer internship.
Key Responsibilities
* Supports the successful development and execution of state-of-the-art manufacturing processes for Current Good Manufacturing Practices (cGMP) within the Cell Therapy Development matrix
* Contribute and support scientific or engineering expertise toward the design and development of new process ideas
* Maintains accurate, detailed records, experimental data and protocols following Lonza’s best documentation practices.
* Prepares data summary and data reports.
Works with Lead Scientists to communicate and summarize results for internal and client meetings, written reports and presentations
* Performs common laboratory maintenance as needed.
Maintains stock of lab supplies and reagents in support of ongoing programs.
* Becomes knowledgeable and complies with all pertinent safety policies, rules and regulations.
* Performs other duties as assigned.
* Supports projects within his/her expertise and experience.
Develops and improves new skills and knowledge necessary to successfully support assigned projects.
Required Education/Training
* Minimum cumulative GPA of 3.0 (out of 4) required
* Must currently be enrolled in BS, MS, and PhD Academic Program
* Must be available for the entirety of the Internship duration from Monday, June 5, 2023 to Friday, August 11, 2023
* Must successfully complete and pass all pre-employment screenings prior to start of internship (after competition of background and drug screening)
Preferred Education/Training
* Completion of Junior or Senior year (typically 60-90 credits) towards a B.S.
degree in a related field, or graduate students enrolled in Masters or PhD Academic Programs
Internship Application Requirements
To be considered for our internship program, you must include the following documents with your application submission by Friday February 17th, 2023:
* Resume/CV
...
....Read more...
Type: Permanent Location: Houston, US-TX
Salary / Rate: Not Specified
Posted: 2023-01-28 07:02:38
-
Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
We are actively recruiting candidates to participate in our 2023 On-site Summer Internship program.
This program is roughly 10 weeks in length and will immerse you into the culture and operations of Lonza Houston.
The Research and Development Intern provides technical support to lead scientists in conducting viral vector production using cell culture in bioreactors and analytical assays in support of R&D and process development activities.
The internship program begins Monday, June 5, 2023 and ends on Friday, August 11, 2023.
Potential interns must be able to commit to at least 40 hours per week throughout the duration of the summer internship.
Key Responsibilities
* Supports the successful development and execution of state-of-the-art manufacturing processes for Current Good Manufacturing Practices (cGMP) within the viral vector production
* Contribute and support scientific or engineering expertise toward the design and development of new process ideas
* Maintains accurate, detailed records, experimental data and protocols following Lonza’s best documentation practices.
* Prepares data summary and data reports.
Works with Lead Scientists to communicate and summarize results for meetings, written reports and presentations
* Performs common laboratory maintenance as needed.
Maintains stock of lab supplies and reagents in support of ongoing programs.
* Becomes knowledgeable and complies with all pertinent safety policies, rules and regulations.
* Supports projects within his/her expertise and experience.
Develops and improves new skills and knowledge necessary to successfully support assigned projects.
Required Education/Training
* Minimum cumulative GPA of 3.0 (out of 4) required
* Must currently be enrolled in BS, MS, and PhD Academic Program
* Must be available for the entirety of the Internship duration from Monday, June 5, 2023 to Friday, August 11, 2023
* Must successfully complete and pass all pre-employment screenings prior to start of internship (after competition of background and drug screening)
Preferred Education/Training
* Completion of Junior or Senior year (typically 60-90 credits) towards a B.S.
degree in a related field, or graduate students enrolled in Masters or PhD Academic Programs
Internship Application Requirements
To be considered for our internship program, you must include the following documents with your application submission by Friday February 17th, 2023:
* Resume/CV
* Transcript
* One letter of recomm...
....Read more...
Type: Permanent Location: Houston, US-TX
Salary / Rate: Not Specified
Posted: 2023-01-28 07:02:37
-
At Milk Specialties Global, our focus is to create high-quality ingredients designed to optimize health and nutrition.
We are passionate and dedicated people.
Each day, we collectively explore new, innovative ways to enhance product performance and value through our broad human and animal nutrition portfolios.
The human nutrition division focuses on industry leading whey and milk protein isolates, concentrates, and hydrolysates - backed by the speed, execution, and passion it takes to exceed the expectation of our customers.
We are currently seeking a Quality Assurance Technician to join the Fond du Lac, WI team.
Starting wage for this position is $22.00 per hour.
The Quality Technician has the responsibility for performing departmental analytical and clerical work in support of the plant Quality function which includes conducting lab tests, preparing samples for shipment, and responding to internal calls.
Ideal candidates will have 1 – 2 years of prior laboratory experience, preferably in a food grade manufacturing facility.
We are committed to identifying and recruiting dedicated and reliable candidates to join the team of passionate employees.
Milk Specialties Global prides itself on advancement opportunities for our current workforce to promote from within.
We offer a comprehensive benefits package which includes medical, dental, vision and life insurance as well as a healthy 401(k) company match program.
The COVID-19 vaccine is encouraged, but not required. Milk Specialties Global closely follows CDC guidelines and updates to ensure employees are able to work safely at our facilities.
OPEN
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Type: Permanent Location: Fond Du Lac, US-WI
Salary / Rate: Not Specified
Posted: 2023-01-28 07:02:12
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ESSENTIAL JOB FUNCTIONS: Works under the general supervision of a Collection Manager in the Solid Waste Division.
Supervises and evaluates the work of subordinate personnel in assigned area(s) engaged in the collection and transportation of solid waste to various disposal facilities and worksites.
Organizes, assigns duties and schedules crew and all necessary resources required to meet daily needs and demands.
Plans, distributes and monitors daily route assignments to ensure customers are serviced per service agreement.
Drives to various worksites and inspects areas to direct personnel and equipment in order to assure “zone and area” complete.
Manages the end-of-day close out process, capturing and communicating key service, safety, and equipment issues.
Reviews daily demand for routes, determines potential gains from re-routing.
Assists with data collection and reporting required for data management.
Works with organized labor groups to resolve employee and labor relations issues.
Investigated all injuries and incidents, ensuring consistent discipline and retraining.
Reviews and audits documentation related to route operations daily (employee time and attendance, open tickets, etc.).
Manages and maintains equipment including vehicle inspections, repairs, maintenance work orders and substitutions while coordinating service delivery with other supervisors.
Locates and tags code violations.
Enters and maintains data in the appropriate systems including adding pictures and other supporting documentation such as property and tax information.
Collects and documents tagged debris by assigning personnel to handle the collection of debris and other pertinent information.
Monitors, resolves, and closes 311 complaint tickets by entering information into the system.
Investigates and resolves citizen concerns, complaints and requests and reports the action taken to management.
Interprets policies for workers, takes the appropriate disciplinary action when necessary according to established rules/practices and confers with personnel representatives to resolve grievances.
Completes reports by utilizing multiple Microsoft applications for management to review and analyze.
Communicates verbally and in writing with general public, management, and other staff members regarding the Solid Waste Division.
OTHER FUNCTIONS:
1.
Performs additional functions (essential or otherwise) which may be assigned.
TYPICAL PHYSICAL DEMANDS: Must be able to communicate clearly verbally and in writing.
Requires ability to lift carts and operate trucks such as rear-end loaders and open-bed.
Must be able to operate a motor vehicle to inspect and observe solid waste collection, processing, disposal and recycling activities including traversing throughout various property grounds.
Requires the ability to operate general office equipment, such as a computer, copier, and telephone and smart phone and or tablet device.
TYPICAL WORKING CONDITIONS: Majority of work is performed out...
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Type: Permanent Location: Memphis, US-TN
Salary / Rate: Not Specified
Posted: 2023-01-28 07:02:09
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The Position
Worker Student for R&D Device Agility Center - Mannheim
Deine Abteilung
Wir sind das Team „Device Agililty Center“ und treiben mit viel Engagement und Leidenschaft das Thema Agilität voran.
Wir sind aktuell 2 Release Train Engineers, 6 Scrum Master und ein Team Lead.
Unser Team zeichnet sich durch Vielfalt aus: Berufserfahrung, Ausbildungshintergrund, Arbeitsort.
Wir unterstützen und coachen Teams in den Themen Agilität, Scrum und SAFe.
Deine Aufgaben
* Vorbereitung und Organisation von agilen Zeremonien
* Pflege und Auswertung der Ergebnisse der agilen Zeremonien
* Mitarbeit an kontinuierlichen Verbesserungen in den agilen Projekt-Entwicklungsteams
* Enge Zusammenarbeit und Abstimmung mit den Release Train Engineers (RTE) der Abteilung
* Erstellung von Dokumentation und Präsentation
Dein Profil
* Du bist immatrikulierte/r Student/in (m/w/d) und mindesten im 3.
Semester eines Bachelorstudiengangs, bevorzugt im Master-Studiengang der Fachrichtung Betriebswirtschaftslehre (BWL) oder vergleichbar.
* Basiswissen im Bereich agilen Entwicklungsmethoden und große Interesse mehr zu lernen
* Erfahrung im Bereich Projektmanagement und Medizintechnik
* Sehr gute Deutsch- und Englischkenntnisse
Deine Vorteile
* Flexible Zeiteinteilung
* Vergünstigte Essenspreise (-50 %) in unserer Mitarbeiterkantine
* Fitnesszentrum auf dem Roche-Campus
* Vernetzung mit anderen Studierenden
Deine Bewerbung
Bitte lade nur Deinen Lebenslauf online hoch.
Denke daran, dass sich dieses Praktikum an Studierende (m/w/d) bei laufender Immatrikulation richtet.
Zeitraum: Ab sofort bis Ende 2023 (es besteht eine Möglichkeit zu verlängern nach Ende 2023).
Wir freuen uns auf Deine Bewerbung!
Dein Kontakt zu uns! With people.
For people.
Du benötigst weitere Unterstützung?
Unser Talent Acquisition Team beantwortet gerne Deine Fragen.
Sende Dein Anliegen bitte an germany.talentaquisition@roche.com
Your contact to us! With people.
For people.
Do you need more support?
Our Talent Acquisition Team welcomes your questions.
Please send an email to germany.talent_acquisition@roche.com
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.
Working together, we’ve become one of the world’s leading research-focused healthcare groups.
Our success is built on innovation, curiosity and diversity.
Our success is based on innovation, curiosity and diversity - and on the fact that we regard our variety as a benefit.
With 40 years of experience in the diabetes business, Roche Diabetes Care is the market leader and a driver and shaper of the future of care for people with diabetes.
Digitisation is an essential element of our work.
Roche is an Equal Opportunity Employer.
....Read more...
Type: Permanent Location: Mannheim, DE-BW
Salary / Rate: Not Specified
Posted: 2023-01-28 07:01:56
-
Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
We have a new opportunity at Lonza to lead the global quality network across Lonza's biologics mammalian sites. This role is responsible for all Quality aspects globally and to deliver a Quality strategy for the biologics mammalian business.
The Senior Director Global Head of Quality, Mammalian Manufacturing will work in partnership with the business unit to create competitive manufacturing.
Key responsibilities:
* Providing leadership for all Quality activities related to the mammalian organization.
* Sets the strategy of the quality function for mammalian manufacturing, developing and maintaining Quality Assurance and Quality Control standards, guidelines and developing policies and procedures to ensure the quality of work in all disciplines.
* Identifies and resolves problems through stakeholders by implementing project-based solutions which deliver improved business performance against critical quality factors.
Detects potential gaps and initiates corrective and preventive actions (continuous improvement).
* Responsible for promoting recognition of company quality programs among customers, as well as developing and implementing employee communication and training programs in connection with the company’s quality objectives, strategies and processes.
* Leads a team of Quality Site Heads: hiring and developing top talent to create high performing teams and succession pipelining.
Ensuring active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
* First contact within mammalian manufacturing for any Quality related topic.
Ensures that new clients receive appropriate information regarding Lonza’s quality systems
* Supporting the sites in the collaboration with authorities and customers which are linked to strategic growth projects.
Key requirements:
* Master’s Degree or equivalent experience ideally in Quality Management, Engineering or related science discipline
* Significant experience in a regulated pharmaceutical industry including, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs.
Experience in biological manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements.
* Proven management experience in an EMA / FDA regulated environment, excellent working knowledge of regulatory requirements and their implementation.
* Leadership role in operations readiness including ...
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Type: Permanent Location: Basel, CH-BS
Salary / Rate: Not Specified
Posted: 2023-01-28 07:01:34
-
The Position
Was Sie erwartet:
Im Bereich der Abfüllung Elecsys werden mit 50 Mitarbeitern mehr als 60 Millionen Reagenzienflaschen pro Jahr abgefüllt.
Mit diesen immunologischen Testreagenzien werden weltweit von unseren Kunden jährlich über eine Milliarde Blutuntersuchungen durchgeführt.
Um den hohen Qualitätsstandard unserer GMP-Produktion zu erhalten, benötigen wir Verstärkung!
* Sie sind zuständig für die Abfüllung von Diagnostika-Ansätzen unter Einhaltung entsprechender Herstellanweisungen und den gültigen GMP-Richtlinien.
* Sie übernehmen die Überwachung und Steuerung einer komplexen, hochautomatisierten Abfüllanlage sowie die Bedienung von Fertigungsleitsystemen.
* Zu Ihren Aufgaben gehören auch einfache, mechanische Tätigkeiten (z.B.
Formatwechsel oder Justierungsarbeiten).
* Die Kalkulation, Bereitstellung, Prüfung, und Erfassung der Verbrauchsmaterialien ergänzt Ihr Aufgabengebiet.
* Die exakte Dokumentation aller durchgeführten Arbeitsschritte ist Ihnen vertraut.
* Zudem sind Sie verantwortlich für die Instandhaltung und Reinigung der Anlagen.
Diese Tätigkeit erfordert die Bereitschaft im 3- Schicht-Betrieb (Früh-, Spät- und Nachtschicht) mit entsprechender zusätzlicher Vergütung zu arbeiten.
Die Durchführung der Arbeiten erfolgt zum Teil unter Reinraumbedingungen und erfordert das Tragen von Schutzkleidung (insbesondere Handschuhe, Mundschutz und Kopfhaube).
Darüber hinaus erfordert diese Tätigkeit das regelmäßige Heben von Lasten bis zu 10 kg sowie den Umgang mit humanen Seren.
Wer Sie sind:
Für diese Position passen Sie am besten mit folgender Qualifikation:
* Sie verfügen über eine erfolgreich abgeschlossene Berufsausbildung als Mechatroniker/ Elektroniker, Anlagenmechaniker (m/w) bzw.
ähnlich, gerne auch Fachkraft Lebensmitteltechnik (m/w), Pharmakant (m/w), Chemikant (m/w) oder eine vergleichbare Ausbildung
* Idealerweise haben Sie bereits Erfahrung in einer vergleichbaren Tätigkeit in einem Produktionsumfeld mit hohen hygienischen Anforderungen
* Erfahrung im Umgang mit Produktionsanlagen konnten Sie bereits sammeln
* Sie zeichnen sich durch gutes technisches Verständnis in der Maschinen- und Anlagenbedienung aus
* Ihre Arbeitsweise ist durch Zuverlässigkeit und Sorgfalt geprägt
* Die Bereitschaft zum Einsatz in versetzten Arbeitszeiten oder Schichtarbeit bringen Sie mit
* Sie haben Freunde an der Arbeit im Team und unterstützen dieses in allen Belangen
Wir bieten eine attraktive Schichtzulage und gute Weiterentwicklungsmöglichkeiten.
Aber noch wichtiger ist uns die Gesundheit unserer Mitarbeiter!
Bewerben leichtgemacht: Bitte laden Sie nur Ihren Lebenslauf online hoch.
Zum aktuellen Zeitpunkt benötigen wir keine weiteren Dokumente, wie Motivationsschreiben oder Ähnliches.
#FacharbeiterDeutschland#
#QuereinsteigerDeutschland#
Your contact to us! With people.
For people.
Do you need more support?
Ou...
....Read more...
Type: Permanent Location: Penzberg, DE-BY
Salary / Rate: Not Specified
Posted: 2023-01-28 07:01:33
-
Today, Lonza is a global leader in life sciences operating across three continents.
While we work in science, there’s no magic formula to how we do it.
Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
In exchange, we let our people own their careers.
Their ideas, big and small, genuinely improve the world.
And that’s the kind of work we want to be part of.
At our site in Visp, Switzerland, we are looking for a QC Scientist who wants to be part of our proactive and young team.
Key responsibilities:
* Planning, coordination and monitoring of QC activities related to physical and chemical analysis
* Writing and review of technical documentation related to QC area (procedures, method transfer and validation protocol/report)
* Technical expertise in analytical problem solving
* Deviation, CAPA and change management.
* QC Lab representative in internal team meeting
* Representative for project-specific requests in GMP audits and client inspections
* On-call duty with pre-arranged assignments as part of the on-call service
Key requirements:
* Master degree (FH/BSc/MSc/Diploma) in biochemistry, biology , chemistry or similar
* minimum 3 years of professional experience in similar role
* leadership, proactivity, good communication and teamwork skills are required
* Advanced knowledge of English complete the candidate profile
Every day, Lonza’s products and services have a positive impact on millions of people.
For us, this is not only a great privilege, but also a great responsibility.
How we achieve our business results is just as important as the achievements themselves.
At Lonza, we respect and protect our people and our environment.
Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
In return, we offer the satisfaction that comes with improving lives all around the world.
The satisfaction that comes with making a meaningful difference.
....Read more...
Type: Permanent Location: Visp, CH-VS
Salary / Rate: Not Specified
Posted: 2023-01-28 07:01:24
-
Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist.
Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen.
Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen.
Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig.
Denn ihre Ideen, ob gross und klein, verbessern die Welt.
Und das ist die Art von Arbeit, an der wir Teil haben möchten.
Für unserer Standort Visp suchen wir einen QC Wissenschaftler Massenspektrometrie (m/w/d).
Als Mitglied in der Qualitätskontrolle sind Sie unter Einhaltung der Qualitäts- und Sicherheitsrichtlinien verantwortlich für die Entwicklung/Validierung/Implementierung sowie Freigabeanalytik von massenspektrometrischen Methoden (LC-MS, LC-MS/MS und GC-MS) in der Analytik chemischer und biopharmazeutischer Moleküle zur klinischen und kommerziellen Anwendung.
Sie sind selbständig im Rahmen der Aufträge tätig und übernehmen Verantwortung.
Dabei sind Sie in engem Kontakt mit anderen QC Gruppen, der Forschung, Produktion und Qualitätssicherung
Aufgaben:
* Personalverantwortung
* Verantwortung für Teilbereiche
* Planung und Mitverantwortung bei der Entwicklung, Implementierung und Validierung von LC-MS, LC-MS/MS und GC-MS Methoden sowie Instandhaltung des Geräteparks
* Fachliche Expertise bei technischen und analytischen Fragestellungen, instrumentellen Analytik sowie die Bearbeitung von Untersuchungen, Änderungsanträgen und Abweichungen unter cGMPExtraktion und Auswertung von analytischen Daten wie auch Verfassen von Berichten und Präsentationen
* Erstellung, Überprüfung und Freigabe von Dokumenten zur Sicherstellung der Einhaltung der behördlichen Richtlinien
Anforderungsprofil:
* Sie verfügen über ein abgeschlossenes Studium (PhD/FH/BSc /MSc/Diplom) im Bereich Biochemie, Biologie oder Chemie.
* Sie haben idealerweise Berufserfahrung im Bereich der Qualitätskontrolle und der Massenspektrometrie und sind vertraut mit den entsprechenden Prozessen unter GMP und/oder in der Analytik von chemischen Molekülen und grossen Bio-Molekülen.
* Erfahrung im Bereich Quantifizierung von Small Molecules erwünscht
* Erfahrung im Bereich Proteinanalytik von Vorteil
* Sie sind selbständig, verantwortungsbewusst und besitzen eine gute Kommunikations- und Teamfähigkeit sowie Freude an interdisziplinärer Zusammenarbeit.
* Sie haben Spass daran, sich in ein junges, dynamisches Team einzubringen, sind engagiert und besitzen Eigeninitiative.
* Sichere Deutsch- und Englischkenntnisse runden Ihr Profil ab
Lonzas Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus.
Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar.
Wie wir unsere Geschäft...
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Type: Permanent Location: Visp, CH-VS
Salary / Rate: Not Specified
Posted: 2023-01-28 07:01:02
