Laboratory Study Lead

The Laboratory Study Leader has overall responsibility for the technical conduct of all assigned tests of medical devices and/or pharmaceuticals as well as for the review, interpretation, analysis, documentation, and reporting of results.

The Study Leader is the single point of study control.

They ensure all assigned studies are completed on time.

A Laboratory Study Leader serves as a Subject Matter Expert (SME) both internally and externally for the testing they oversee and related industry regulations.

They will represent well the testing they oversee both verbally and in writing.

Education and experience requirements:


* B.S.

degree (life science strongly preferred) and 2+ yrs applicable laboratory coordination experience (medical device or pharmaceutical product testing preferred)
+ OR


* High School diploma or GED and 6 yrs years applicable laboratory study leadership experience (medical device or pharmaceutical product testing preferred)

Essential Duties:


* Customer Service - Serve as a technical and scientific point of contact on both video conference calls and in person client visits.


* Serve as the subject matter expert (SME) on assigned standards and apply them appropriately to laboratory testing, providing guidance to lab analysts.


* Identify and resolve complex scientific problems.


* Actively participate in business strategies specific to the respective scientific department


* Own section test method and equipment validations, including procedure development.


* Regulatory & Compliance - Address findings from internal and external/regulatory audits & Assist with CAPA assignments as needed.


* Project Management - Coordinate with clients and other sections regarding test requirements for routine and non-routine studies.

Travel

Occasional local travel during the business day and occasional out of the area or overnight travel may be expected 1-2 times per year.

Physical requirements:

The physical demands described here are a representative of those that must be met to perform the essential job functions.


* Requirements to stand and traverse to various office and lab locations and sit at a computer workstation will vary.


* Bending, stooping, and crouching.


* Occasional push and pull with one or both hands.


* Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc.


* Must be able to lift up to 25lbs.

Work Environment:

This job operates in a professional laboratory environment.

This role routinely uses standard office and lab equipment including but not limited to computers, telephones, microscopes, micropipettes, pipette aids, various hand tools, and analytical equipment.

The possibility exists for exposure to biological and chemical hazards, exposure...