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Senior Scientist / Senior Manager for Cell Culture Process Development

Date: Jan 11, 2019

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

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 Scientist/Senior Manager for Cell Culture Process Development will be a key talent responsible for all aspects of cell culture processes design and optimization, working with our internal partners in Research and Development, Manufacturing, Quality, Regulatory and external CROs, and CMOs to enable speed to clinic and robust commercial manufacturing process design, characterization, process validation and regulatory filings.

 

Responsibilities

Subject matter expert in all aspect of cell culture process design, optimization, characterization, and implementation of integrated control strategies applying QbD principles.

Upstream development for early to late stage projects, support scale up and technology transfer to internal or external manufacturing facilities.

Evaluate next generation high productivity cell culture process technology and define the strategy for implementation.

Ensure effective information flow, timeline execution, trouble shooting, and issue resolution in multi-disciplinary matrix organization.

Author technical reports. Write and review CMC sections of regulatory filings and regulatory question responses.  

Provide scientific leadership, mentor and develop junior employees, and create a working environment that values scientific rigor, collaboration and accomplishment with shared responsibility and a sense of urgency. 

Qualifications

Ph.D in Chemical/Biochemical Engineering or related field with 4+ years relevant experience in biopharmaceutical environment or MS with 9+  years of relevant experience.

Hands on experience with process design, optimization and scale up.  

QbD approach in process development and process characterization.

Working knowledge of analytical techniques for product characterization.

Experience in supporting tech transfer and PPQ.

Versed in cGMP, biologics CMC regulations, experience in preparing regulatory documents.

Managerial experience is preferred.

Experience with high productivity cell culture process design and optimization is preferred.

Function

Research & Development

Sub Function

Drug Analysis and Formulation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


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