Technical Services Manufacturing Scientist - Downstream

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We believe that diversity is the driving force behind innovation, creativity, and overall business success.

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Your Role: Technical Services Manufacturing Scientist - Downstream

The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial downstream operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.

The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities.

The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects.

Your Responsibilities:


* Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products.

This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.


* Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation.


* Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.


* Develop / execute projects to address process performance issues and deliver improvement opportunities.


* Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.


* Experience: Experience in the Biotech / Pharmaceutical industry.


* Detailed understanding of biopharmaceutical production processes and technologies.

Working knowledge of cGMP standards and experience working in...