1+ months

Associate Director, Immunogenicity

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 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.
Qualifications

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

      OR

  • 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
Function
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

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Categories

Posted: 2020-08-03 Expires: 2020-10-01

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

Teva Pharmaceuticals
West Chester, PA 19380

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