Company Info

Job Description

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high quality healthcare by developing, producing and marketing affordable generic and innovative drugs. Teva is aggressively increasing its biologics activities in both biosimilar and innovative biologics in respiratory, CNS, pain and oncology therapeutic areas.  The Biologics CMC is located in West Chester, PA site, with a state of the art biologics cGMP facility and R&D development labs. The site will support CMC development of products from IND through BLA.  

As the Senior Manager of the PDA team you will be the technical expert on analytical test methods for biologic product quality and process performance.  PDA team, which is in Process Development (PD) department, supports analytical test demands of PD functions, including upstream and downstream processing of biologics. In this role you will lead the PDA team to perform assays for supporting PD functions, to align assay methods with Analytical Sciences & Operation (ASO) department, and to introduce new assay methods or new technologies for analyzing biologic product quality, process intermediates, or impurities.

Responsibilities:

• Manage the PDA team to perform various assays on LC, ELISA, qPCR, and electrophoresis platforms to support the upstream and downstream process development activities for biologics production in a timely and high throughput manner. The assays include those on product quality (size and charge distribution, glycan profiles), impurities (HCP, residual DNA, residual Protein A measurement), and process performance (product titer, amino acids analysis, trace metal analysis).
• Assist Process Development scientists to design experiments, provide assay strategy and data interpretation guidance for development studies, such as cell culture media optimization, purification parameter screening, viral clearance, etc.
• Collaborate with the Analytical Sciences & Operation (ASO) department to understand and align all the applicable assay platforms, sample testing management, and technology evaluations. 
• Adapt assays to high throughput platform. Develop new assay methods as needed. Evaluate and adapt new technologies when it is appropriate.
• Manage routine sample testing, instrument and equipment maintenance, and resources (people and reagents) to ensure smooth operation and normal function of the PDA team, and completion of tests in timely manner. Manage and train associate scientists to perform assays.
• Write reports and keep lab notebook records in a compliant manner.
• Present results internally or outside the organization.

Qualifications

What you will bring to the role:

• PhD degree in chemistry, biochemistry, physical chemistry, molecular biology, chemical engineering or related fields, with 5+ year experience in analytical method development or Quality Control functions, or MS degree in above fields with 7+ year experience.
• Minimum 1 year of experience in analytical assay platforms for analyzing biomolecules (proteins, peptides, etc). The platforms include (but are not limited to) HPLC, UPLC, capillary electrophoresis, ELISA, qPCR.
• Minimum 1 year of experience in people management.

Preferred Qualification:

• Understanding in protein biochemistry, purification of biomolecules, cell biology, and cell culture process.
• Experience in high throughput assays.
• Excellent communication skills, and capability of learning and adapting new technologies
• Track records of publications and presentations at conferences.

Function

Sub Function

Reports To

Senior Director, Process Development, Biologics CMC

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Tevas 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, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.