1+ months

Senior Director Drug Substance 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

The Senior Director of Process Development will lead drug substance process development for Tevas innovative and biosimilar products. This leader will be responsible for primary clone selection, early and late-stage process development, scale-up to pilot and commercial scales, technology transfer to clinical and commercial manufacturing sites, Process Performance Qualification activities, and regulatory filing.  This individual will lead a talented and diverse process development team comprised of scientists and engineers.   The leader will collaborate extensively with the Cell Line Development group, Biosimilar group, Commercial Operations, Clinical Development group, Quality Assurance and Regulatory Affairs.  He/she will oversee and manage extensively equipped upstream and downstream process development laboratories with high-throughput process development capabilities and matching analytical technologies.  He/she will define the requirements of process platform and evolve the platform with new technologies. This leader will author the CMC sections of regulatory filings, address relevant questions from global jurisdictions, and support inspections working with the Compliance and QA teams.  This will require direct interaction with inspectors and auditors.  He/she will lead collaboration projects with external companies and suppliers.  This leader will develop strategies, set direction and provide guidance as a member of the CMC Leadership Team. He/she will tirelessly develop staff, create opportunities for technical and personal development of the team, and create the next generation technical leaders for the company.

Qualifications
  • MS/PhD in Biology, Immunology, Biochemistry or Biochemical Engineering
  • 16 or more years of combined experience in process development or manufacturing sciences in biopharmaceutical/biotechnology industry
  • End-to-end understanding of biopharmaceutical product development lifecycle
  • Demonstrated success of managing technical teams with diverse background and leading the teams to achieve business objectives, leadership attributes and highest levels of performance standards
  • Relevant publications in peer-reviewed journals and recognition in peer community
  • Experience of functioning as process science subject-matter expert in cross-functional project teams
  • Experience of developing and implementing new cell culture processes with high productivity through media and nutrient optimization and new process technologies such as perfusion and continuous/connected processing
  • Experience of taking primary responsibility for regulatory filings and questions/answers
  • Experience of working with contract laboratories and contract manufacturing organization
  • Experience of statistical data modeling and multivariate analysis tools
Function
Research & Development
Sub Function
Drug Development and Preclinical Studies
Reports To

VP Biologics CMC

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: 2020-06-04 Expires: 2020-11-01

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 Director Drug Substance Process Development

Teva Pharmaceuticals
West Chester, PA 19380

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