29 days old

Senior Scientist, Process Development and Technology Transfer

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 manage and support the development of Teva innovative and biosimilar product pipeline for manufacture into drug product.  The incumbent will be responsible for 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.  In addition, the candidate will lead and participate in cross-functional teams as a representative of DPDO.

 

Responsibilities:

  • Development of drug product manufacturing process and execution of process characterization
  • Development of  scale down models that are applicable to the drug product manufacturing processes
  • Authorization of protocols, reports, risk assessment, and other technical documents
  • DP technology transfer to the GMP fill/finish area for clinical supplies and the subsequent technology transfer to commercial manufacture sites.
  • Representing DPDO in cross functional matrix teams as it relates to biosimilar and novel biologic products within Teva.
  • Coordinate and interface with GMP manufacturing facility or external contracting organization for the manufacture of drug product non-clinical and clinical batches as appropriate to progress the biologic pipeline.
  • Provide technical support to troubleshooting issues with drug product processing technologies and equipment.
  • Serve as a subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective and preventative actions
Qualifications

 

Required Qualifications:

  • Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering or other scientific field of study with 3+ years of experience in drug product development or manufacturing.

OR

  • Masters degree in Pharmaceutical Sciences, Biochemistry, Chemical Engineering or similar scientific field of study with 7+ years of experience in drug product development or manufacturing.

OR

  • Bachelors degree in Pharmaceutical Sciences, Biochemistry, Chemical Engineering or similar scientific field of study with 10+ years of experience in drug product development or manufacturing.
  • 2+ years Biologic DP process development and fill/finish experience including training on aseptic processing of sterile products.

 

Preferred Qualifications:

  • Understanding of CMC requirements for regulatory submissions such as INDs, NDAs and BLAs, with experience authoring relevant DP sections.
  • Experience working in cross functional matrix teams and collaborating with CMOs
  • 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.
  • Excellent planning, verbal and written skills. Good document practices a must.
  • Experience with single-use manufacturing technologies
  • Experience conducting process characterization with minimal supervision
  • Demonstrated ability to work in cross-functional teams across the business
  • Strong organizational skills and attention to detail
  • Excellent written and oral communication skills and strong team player
  • Experience with development of small scale models and statistical design software a plus

 

Function
Research & Development
Sub Function
Drug Analysis and Formulation
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

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Categories

Posted: 2020-07-09 Expires: 2020-08-22

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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Senior Scientist, Process Development and Technology Transfer

Teva Pharmaceuticals
West Chester, PA 19380

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