1+ months

Senior Scientist

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

 

We are seeking a highly motivated individual with experience in anti-drug antibody (ADA) and neutralizing antibody (NAb) assay development, validation and sample analysis in support of immunogenicity assessment of biologics. Experience of cell-based innate immune response assays in support of immunogenicity risk assessment of Generic Peptides is desired. 

 

You will be a member of Specialty Bioanalytics at our West Chester, PA location, which 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. 

 

Responsibilities:

  • Initiate, develop, and execute scientific research and development that is critical to corporate strategies
  • Independence in the design, development, trouble shooting, validation and conduct of the assay to support preclinical and clinical immunogenicity assessment
  • 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.
  • 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
  • Responsible for the management and professional development of a research group. Mentor associate scientists or research associates as required
  • Work with cross functional teams and present assay strategy and data at internal meetings as well as conferences outside
Qualifications

 

Minimum Requirements:

  • Bachelor's degree in scientific field of study such as Biology or Chemistry with 12+ years of experience working in immunogenicity and bioanalytical assay in pharmaceutical and/or CRO industry; Master's degree in scientific field of study with 8+ years of experience working in immunogenicity and bioanalytical assay in pharmaceutical and/or CRO industry; PhD in scientific field of study with 5+ years of experience working in immunogenicity and bioanalytical assay in pharmaceutical and/or CRO industry
  • 2+ years of experience working in a regulated environment
  • 2+ year of managerial experience

 

Preferred Qualifications:

  • Working knowledge of GLP, GCP, SOPs and regulatory guidelines related to immunogenicity assessment
  • Hands on experience with ADA and NAb method development, validation and execution of immunoassays for immunogenicity assessment
  • Previous experience developing cell-based and ligand binding NAb assays
Function
Research & Development
Sub Function
Drug Analysis and Formulation
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.

Categories

Posted: 2020-05-29 Expires: 2020-07-09

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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Senior Scientist

Teva Pharmaceuticals
West Chester, PA 19380

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