Scientist I - 1487
Date: Jun 21, 2022
Location: West Chester, US, 19380
Company: Teva Pharmaceuticals
Who are we?
Job Description
Biologics CMC is a division of Teva Pharmaceuticals responsible for the development of biologics. The rapidly growing staff of Biologics CMC specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. Drug Product Development and Operations (DPDO) is a function within Biologics CMC dedicated to development of formulation, drug product configuration and manufacturing process of the non-clinical and the clinical drug products. You will play a key role in DPDO to support the formulation development of Teva innovative and biosimilar product pipeline for manufacture into drug product.
As a Scientist, the successful candidate will lead projects and studies, execute test, organize the data and author related technical documents, all in compliance with regulatory guidance and applicable policies.
Qualifications
- Required: Minimum of a BS in pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with 8 years relevant experience in biologics formulation development and/or analytical development. ( MS with 4 years experience or PhD with 0 years experience)
- Required: Minimum 3 years hands-on experience in biologic formulation development and analytical testing using biophysical and biochemical, characterization methods, such as general appearance, opalescence, osmolality, MFI, HIAC, viscosity, HPLC, DLS, DSC, and CD spectroscopies.
- Required: Excellent planning, verbal and written skills. Good document practices is a must.
- Required: Proficient in Microsoft Office Suite of Programs.
- Preferred: Experience with determining a self-association propensity of biologic utilizing the Gibbs free energy (ΔG) and/ or static light scattering is a plus.
- Preferred: MS w/ 4 years or PhD w/0 years of experience in pharmaceutical sciences, biochemistry, chemical engineering, or other related discipline.
- Preferred: Formulation and/or process development experience including the analysis or characterization of proteins required.
- Preferred: Experience in high throughput experiments and/or development of high concentration protein formulations and biologic-device combination products.
- Preferred: Experience in application of a statistical software (eg. JMP), or implementation of QbD elements.
Function
Sub Function
Reports To
Associate Director, DPDO
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