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Associate Director, Immunogenicity

Date: Dec 26, 2020

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

Teva’s 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 Associate Director of Immunogenicity will possess technical experience in anti-drug antibody (ADA) and neutralizing (NAb) assay development along with validation and sample analysis in support of immunogenicity assessment of biologics. They will serve as a scientific/technical expert on projects. Lead team on method validation and sample analysis in a regulated environment, and immunogenicity risk assessment of generic peptides using cell-based Innate Immune Response assays, etc.


As an Associate Director you will utilize your leadership skills to supervise your team and manage the professional development of the research group


You will be a member of Specialty Bioanalytics at our West Chester, PA site. This site plays a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, early to late phase clinical studies through BLA submission and post marketing support.


Additional responsibilities:

  • Initiate, develop, and execute scientific research and development that is critical to corporate strategies, and identify applications of functional knowledge and existing methodologies to complex problems.
  • Independence in the design, development, trouble shooting, validation and conduct of the assay to support preclinical and clinical immunogenicity assessment
  • Manage designated studies and act as the point person throughout various phases, including assay maintenance, trouble shooting, assay performance check, interaction with QC/QA, and meeting study timelines. Ensure accurate results are reported and transferred.
  • Contribute to and author relevant regulatory submission document (pre-IND, IND, IB, BLA, etc.)
  • Lead and coordinate all aspects of one or more drug development projects/programs representing Specialty Bioanalytics, and present assay strategy and data at internal meetings as well as conferences outside.


Minimum Qualifications:

  • Master's degree in Immunology, Pharmacology, Biology or other scientific related field of study with 12+ years of experience in immunogenicity and bioanalytical assay experience in CRO and/or pharmaceutical industry


  • PhD in Immunology, Pharmacology, Biology or other scientific related field of study with 9+ years of experience in immunogenicity and bioanalytical assay experience in CRO and/or pharmaceutical industry 
  • 2+ years of managerial experience
  • 2+ years working in immunogenicity prediction or immunogenicity assay development and/or validation and/or sample analysis


Preferred Qualifications:

  • Demonstrated scientific knowledge and abilities to achieve high barrier scientific goals
  • Working knowledge of GLP, GCP, SOPs and regulatory guidelines related to immunogenicity assessment
  • Previous experience on immunogenicity prediction and risk assessment is highly preferred
  • Excellent written & verbal communications and interpersonal skills
  • Proficient in Excel and Microsoft Office, as well as Watson LIMS lab data management system
  • Experience in data review, data summary, and preparation of validation and sample analysis reports
  • Able to work collaboratively in a multi-cultural fast-paced environment with ability to handle multiple tasks, and set priorities to meet study timelines


Research & Development

Sub Function

Drug Development and Preclinical Studies

Reports To

Director, Immunogenicity Assessment

Already Working @TEVA?

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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, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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