30 days old

Senior Scientist, Cell Culture Process Development

West Chester, PA 19380
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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

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.

 

As the Senior Scientist in the Process Development department of Biologics CMC you will be accountable for delivering robust cell culture processes for innovative biologics and biosimilar molecules. You will work closely with a multi-disciplinary project team, execute projects aligned to meet the goals of the business unit and be accountable for refining and delivering platform solutions to advance Tevas pipeline of biopharmaceutical products.

 

In addition, you will lead technology development programs to improve productivity, product quality, and efficiency of cell culture processes (e.g., perfusion, connected/continuous processing etc.).

 

Other duties include:

  • Independently design and perform process development studies on mammalian cell culture and harvest processes at bench scale and/or pilot scale, using engineering principles
  • Lead a group of associates and scientists working on mammalian cell culture process development
  • Perform data analysis and troubleshooting on cell culture study results
  • Author technical reports for documentation of process development and tech transfer activities
  • Lead a compliant laboratory operation in accordance with SOPs, internal procedures and policies
  • Lead or support technology transfers to internal or external manufacturing sites
  • Contribute to product commercialization efforts by participating in cross-functional project commercialization team.
  • Provide technical leadership at internal and external collaborations
  • Provide technical support to resolve manufacturing issues as an upstream Subject Matter Expert (SME)
  • Author regulatory filing documents (IND, BLA, MAA)
  • Refine high-throughput process development technologies coupled with high-throughput analytics

Qualifications

What you will bring to the role:

  • Bachelors degree in Biology, Biotechnology, Biochemistry, Chemical Engineering, Biochemical Engineering or other related science/ engineering field with a minimum 10 years of experience in biopharmaceutical/biotech industry, or Masters degree with minimum 8 years of experience, or with PhD no industry experience required
  • Minimum 5 years of experience in design and execution of studies for upstream (cell culture or fermentation) process development of biopharmaceutical production with mammalian and/or microbial expression systems, with an understanding of cell harvesting step

 

Preferred Qualifications:

  • Hands-on experience in laboratory and/or pilot scale bioreactors
  • Experience in commercial production of biologics 
  • Comprehensive knowledge in correlation between biologics product quality and cell culture/ purification processes
  • Well versed in literatures, patent landscape, and regulatory guidelines on biopharmaceutical production
  • Proficiency in cell culture data analysis using statistical and multivariate analysis tools and models
  • Experience with automated high-throughput cell culture systems and integrated analytics
  • Thorough understanding of protein chemistry, cell biology, metabolic pathways related to recombinant protein production
  • Experience in cell culture medium or feed development
  • Proficiency in cGMP principles, and how they are related to process development of biopharmaceuticals
  • Experience in authoring technical documentation and regulatory filing documents

Function

Research & Development

Sub Function

Drug Analysis and Formulation

Reports To

Director of Upstream Process Development

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.

Posted: 2021-04-15 Expires: 2021-06-13

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, Cell Culture Process Development

Teva Pharmaceuticals
West Chester, PA 19380

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