Principal Scientist
Date: Aug 5, 2022
Location: West Chester, Pennsylvania, US, 19380
Company: Teva Pharmaceuticals
Company Info
Job Description
As a Principal Scientist - Bioassays and Biosciences in the Analytical Sciences Operations department at Teva, the candidate will be responsible for managing the development and implementation of cell-based and ligand binding assays, and be a recognized subject matter expert for these methods. The position also provides the opportunity to contribute to strategic planning for product characterization assessments; and work with cross-functional team to advance biologic drug development at Teva's West Chester location.
We are looking for a candidate with demonstrated expertise in the development of ELISA and cell-based potency functional assays. The successful candidate may manage one or more analysts and will provide scientific input and broad method knowledge for stage appropriate development of methods which mimics a drug candidate mechanism of action.
The successful candidate will be responsible for managing assay design/controls, troubleshooting, data evaluation, method qualifications and sample testing to support regulatory submissions for Teva’s broad portfolio of biologic drug candidates. The candidate should have experience in a variety of cell methods and technologies for assessment of potency (e.g. cell proliferation, cell signaling, cytokine expression) and effector function (e.g. ADCC and CDC assays). A knowledge of transient/stable cell line generation and/or flow cytometry, cell sorting, or profiling cell responses to ligands is preferred.
In this role you may be responsible for successful management of one or more technical analysts, including day to day activities, training, and career development. The candidate will work closely with Analytical Sciences, CMC, and project managers as a departmental project representative. The position requires the ability to deliver characterization methods for biologics drug candidates against project deadlines and aptitude to provide strategic input on biologic project development.
Other duties:
- Responsible for authorship and/or review of SOPs, development reports, qualification protocols and reports, and contribute to authorship of regulatory submission documents.
- Responsible for assessing and meeting project timelines.
- May oversee aspects of technology transfer to internal and external sites and engage, support, and review work conducted at CROs.
- May engage in long-range project or technological planning and assist in developing budgets for capital expenditures and contracts.
- Familiarity with GMP potency assay compliance requirements and procedures a plus.
Qualifications
- PhD degree in Biochemistry, Cell Biology or other life sciences related field of study
- At least 7 years of experience in pharmaceutical industry developing cell-based functional assays
- At least 2 years of experience in directing/ managing scientific team
Function
Sub Function
Reports To
Laurie Pukac
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