29 days old

Biological Researcher

West Chester, PA 19380
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description

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.

The current position will be a key leadership role in DPDO to support the development of Teva innovative and biosimilar product pipeline for manufacture into drug product. The incumbent will be responsible for supporting the drug product manufacturing process development, process characterization, and technology transfer for drug product manufacture and process validation to the biological manufacturing facility and commercial sites.

Responsibilities:

  • Perform lab based experiments to support drug product development.
  • Lead owner for multiple analytical instrumentation that support formulation drug product process development, which include writing SOPs, working as a subject matter expert (SME), and maintaining the instrumentation in the lab.
  • Author study protocols and reports. Maintain a laboratory notebook including timely recording of experiments, data analysis and review.
  • Work with project lead on DP process characterization studies, including hands-on implementation of the studies in the laboratory.
  • Assist in the manufacture of drug product non-clinical batches and support running the development fill/finish line. This responsibility includes thorough knowledge of development fill/finish line that enables the execution of fill/finish operations when the lead of the development area is not available.
  • Support interactions with internal manufacturing sites and/or external contracting organization as necessary to accomplish DPDO activities.
  • Support interactions with external contracting organization as necessary to accomplish DPDO activities.
  • Represent DPDO in external technical forums.
Qualifications

Minimum Requirements:

  • Bachelor's degree in scientific field of study with a minimum of 7 years or Master's with minimum of 5 years of experience in biological product development
  • Minimum of 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 a must
  • 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
  • Prior experience in GMPs, drug product fill/finish of sterile products, formulation development of proteins and writing of regulatory submissions is a plus
  • Proficient in Microsoft Office Suite of Programs and at least one statistical software
Function
Research & Development
Sub Function
Biological Research
Reports To

Director, Biologics Drug Product

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Categories

Posted: 2020-10-30 Expires: 2020-12-23

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Biological Researcher

Teva Pharmaceuticals
West Chester, PA 19380

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