Sr Director Potency and Characterization
West Chester, United States, Pennsylvania, 19380
Who we are
The opportunity
The person hired for this position will need to sit out of our West Chester, PA site 5 days a week
Leads and coordinates all aspects multiple diverse pharmaceutical R&D projects/programs with respect to the Characterization and Bioassay for Innovative Biologics Development. Utilizes expertise and leadership skills to direct staff and resolve issues to ensure project goals and timelines are met. Drive innovative/creative culture in delivering business results. Willingness to challenge boundaries. Excellent organization and problem solving skills. Engage, coach, mentor and empower others to reach their full potential.
How you’ll spend your day
Within Biologics CMC’s Analytical Development Team, oversee the Characterization and Potency sub functions consisting of approximately 22 scientists ranging from advanced degrees and experience to new bachelor scientists, responsible for product characterization, including functional ( Potency and Binding) assay development and Mass Spectrometry (MS) analyses techniques for candidate programs. Responsible for leading and managing a aspects of bioassay and MS assay development, assay qualification (leading to validation) and sample analysis activities.
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.
Monitor completion of tasks and projects according to agreed and accepted milestones. Collaborate on patent applications and manuscripts of publications. Assist in developing budgets for CAPEX, labor and contracts. Provide oversight and authorship (where necessary) for regulatory fillings and support oversight for any CRO activities, (outside of our internal development activities)
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.
Your experience and qualifications
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
OR
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
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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