20 days old

Associate Director, Immunogenicity Assessment

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

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 Associate Director of Immunogenicity Assessment 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. You will serve as a scientific/technical expert on projects.


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 various assays to support preclinical and clinical immunogenicity assessment.
  • 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, DC-T cell assay, etc.
  • 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.
  • Act as project representative to coordinate all aspects of one or more drug development programs representing Specialty Bioanalytics, and present assay strategy and data at internal meetings as well as conferences outside. 
  • Contribute to and author relevant regulatory submission document (pre-IND, IND, IB, BLA, etc.)


What you will bring to the role:

  • Master's degree in Immunology, Pharmacology, Biology or other scientific related field of study with a minimum of 12 years of experience OR a PhD with a minimum of 9 years in immunogenicity assays or flow cytometry assays in CRO and/or pharmaceutical industry
  • Minimum 2 years of managerial experience
  • Minimum 2 years working experience as a project representative in project team(s) and reviewer of regulatory submission documents


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 in vitro immunogenicity platform such as DC-T cell assay 
  • Able to present data as well as other presentations to team/group in an effective manner
  • 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?

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.


Posted: 2021-02-09 Expires: 2021-03-28

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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Associate Director, Immunogenicity Assessment

Teva Pharmaceuticals
West Chester, PA 19380

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