Company Info

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.

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

Sub Function

Reports To

Senior Manager, Analytical Integrator

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