The Laboratory Study Leader (Study Director) 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. They are the single point of study control. The Study Leader ensures all assigned studies are completed on time. This role also 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.
Essential Duties:
Scientific/General
Become the subject matter expert (SME) on assigned standards and apply them appropriately to laboratory testing.
Identify and resolve complex scientific problems.
Actively participate in business strategies specific to section
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.
Customer Service
Serve as a technical and scientific expert with on-site sponsor or sales visits.
Assist with annual pricing review.
Project Management
Coordinate with sponsors and other sections regarding test requirements for routine and non-routine studies.
Competencies of this position
Scientific understanding of testing performed in multiple laboratory sections.
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 to carcinogenic compounds and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.
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.
Education and experience:
Required:
Bachelors Degree in a Life Science, and 2+ yrs applicable laboratory coordination experience (medical device or pharmaceutical product testing preferred)
OR
High School diploma/GED and 6 yrs years applicable laboratory coordination experience (medical device or pharmaceutical product testing preferred)
Preferred (Not Required):
Masters degree in a Life Science
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