Company Info

Job Description

Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

Located in West Chester, PA, 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 product lots. 

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 Biological Researcher you will be the lead owner for multiple analytical instrumentation that supports formulation development, which includes writing supporting SOPs, working as subject matter expert (SME), training as needed and maintaining the instrumentation. In addition you will assist in the manufacture of drug product non-clinical batches.

Other Responsibilities:

• Formulation development of biopharmaceuticals with hands-on working in the lab for testing by physical, biochemical and characterization methods such as general appearance, opalescence, osmolality, MFI, HIAC, viscosity, UV-Vis spectroscopy, HPLC,  DLS, DSC, FTIR and CD spectroscopies.
• Maintain a laboratory notebook including timely recording of experiments, data analysis and review.
• Writing technical protocols and associated reports in support of formulation development.
• Support interactions with external contracting organization as necessary to accomplish DPDO activities.

Qualifications

Minimum Requirements:

• BS in Chemistry, Biology, Biotechnology or other related life science with a minimum of 10 years or MS with minimum 7 years of experience in biological product development.
• Minimum 3 years hands-on experience in analytical testing using physical and biochemical characterization methods, such as general appearance, opalescence, osmolality, MFI, HIAC, viscosity, HPLC, DLS, DSC, and CD spectroscopies.

Preferred Qualifications:

• Knowledge of current regulatory guidelines related to biologic pharmaceutical development. 
• Excellent planning, verbal and written skills. Good document practices.
• Highly motivated individual, with ability to work in a team environment and build productive relationships within or across departments.
• Ability to troubleshoot and determine creative solutions to better processes.
• Proficiency in Microsoft Office Suite of Programs 
• Prior experience in formulation development of proteins, and GMPs 

Function

Sub Function

Reports To

Senior Scientist

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