1+ months

Senior Scientist

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

The Analytical Integrator - Senior Scientist will work as an individual contributor in the Biologics CMC division of Teva at West Chester, PA. Candidate should be thoroughly knowledgeable of US government regulations, understand international regulations, be able to train others in these regulations and implement these regulations in the workplace.

A good understanding of the drug development process is required. You will work with SMEs, the function heads of Biologics CMC, RA and QA to develop analytical and stability strategy and integrate all information in a written document to include but not limited to product testing plan, stability study plan, and analytical method validation and transfer plans.

As a member of the Analytical Sciences and Operations team, you will serve as a liaison to communicate analytical and stability strategy to other function teams. You will author and review analytical methods, protocols, reports, INDs, IMPDs, and BLAs sections as appropriate.

Other duties:

  • Participate in CMC technical meetings as a QC lead and support other analytical leads and QC managements as needed.
  • Manage method transfer and validation activities to Teva internal or external sites. Provide review and approval of related documentation.
  • Responsible for analytical method life-cycle management and process improvement. Develop and maintain department knowledge, experience, expertise in state-of-the-art analytical methods and equipment for pharmaceutical products.
  • Track the progress according to overall CMC project and analytical development and QC timelines.
  • Initiate and oversee change controls as appropriate.
Qualifications

Minimum Qualifications:

  • Bachelors degree in Biology, Chemistry, Analytical Chemistry or other related science with a minimum of 10 years of experience in analytical development in a biopharmaceutical industry

OR

  • Masters degree with a minimum of 7years of experience in analytical development in a biopharmaceutical industry

OR

  • PhD with a minimum of 5 years of experience in analytical development in a biopharmaceutical industry

Preferred Qualifications:

  • Hands-on experience in analytical method (HPLC, CGE, icIEF, ELISA) development
  • Biologics CMC development knowledge and experience highly desirable
Function
Research & Development
Sub Function
Drug Analysis and Formulation
Reports To

Senior Manager, Analytical Integrator

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: 2020-10-29 Expires: 2020-12-31

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

Teva Pharmaceuticals
West Chester, PA 19380

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