Teva Scientist Drug Product Development 

United States, Pennsylvania, East Bradford Township 

98767686

This position is located out of West Chester, PA and the person hired is required to be onsite 5 days a week

• Design and execute the experiments based on QbD principles, evaluate quality of the data and work on ways to improve data analysis and presentation formats.
• Represent DPD for selected project in cross functional project management teams, as needed.
• Effectively collaborate with different CMC functions as well as other non-technical teams in Teva to facilitate routine operations.
• Design and execute formulation and process development studies.
• Perform routine analytical tests. Generate and organize data in compliance with regulatory guidance and applicable policies.
• Author protocols, reports, technical documents and other relevant regulatory filings documents including IND/IMPD and marketing applications, as needed.
• Assist in the set-up and maintenance of research labs including ownership of instrumentation, authorize instrument working instructions and serve as subject matter expert for the related analytical technologies.
• Support manufacturing technology transfer, as appropriate.
  

Minimum Requirements:

• MS or BS in pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with 4+ or 8+, respectively, years relevant experience, Ph.D. in a similar discipline with 0-4 years relevant experience.
• Minimum 3 years hands-on experience in biologic product 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.
• Excellent planning, verbal and written communication skills.

Preferred Qualifications:

• Formulation and/or process development experience including the analysis or characterization of proteins required.
• Experience in application of a statistical software (eg. JMP), or implementation of QbD elements.
• 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 achieve better processes.
• Experience in GMPs, biopharmaceutical industry and/or writing of regulatory submission documents.
• Proficient in Microsoft Office Suite of Programs.

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