Teva Sr Director Potency Characterization 

United States, Pennsylvania, East Bradford Township 

835578699

The person hired for this position will need to sit out of our West Chester, PA site 5 days a week

Responsibilities include being an active member of the AD leadership team, assist in tracking, managing, and to provide oversight of biologics drug development, strategy, compliance and regulatory submission practices, as well as some FTE and budget resourcing. Lead and be a part of the Analytical Development leadership team, to assist in planning, coordinating and leading the activities of product characterization and potency functional assays for innovative (and biosimilar) drugs (as needed), according to ICHQ6. Collaborate with project teams on assays and planning relevant to long term objectives and concerns. Communicate with inter-organizational teams concerning projects, operational decisions and scheduling requirements.

Quality management & Personnel:

• Ensures the following for self and direct reports:
• Establishment and implementation of SOP’s relating to development space lab testing.
• Ensure test methods comply with relevant (phase appropriate) regulatory guidelines
• Ensure correct, accurate, precise and verified results are reported
• Responsible for supervision, training and management of lab staff.
• Responsible for evaluations of performance, promotions and qualifications of potential new hires.

Required:

• MSC/PhD related science field with a minimum 15 years in Bioanalytical lab and MS characterization lab.
• Extensive knowledge and background in Drug Development and regulatory guidelines related to functional assays and extended characterization of biologic molecules.
• Pharmaceutical Industry experience

Will consider at a Director level:

• BS/MS or PhD preferred or other advanced degree in a relevant technical discipline (e.g. Biochemistry, Microbiology, Biochemical engineering)
• Minimum 12 years pharma/biotech industry experience with deep technical experience in one or more areas of drug development

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