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Scientist

Date: Feb 7, 2019

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

 

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.  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

  • Design, develop, and validate anti-drug antibody and neutralizing antibody assays in support of preclinical and clinical immunogenicity assessment
  • Lead team on method validation and sample analysis in a regulated environment, including but not limited to planning assay runs in Watson LIMS, performing the assay, and batch record review
  • Carry out data analysis and data summary using Watson LIMS and Excel, etc. Prepare for immunogenicity data transfer
  • Write regulatory submission document including method SOP, method validation reports, sample analysis reports and correspondence documents
  • Manage designated studies and act as the point person throughout various phases, including assay maintenance, troubleshooting, assay performance check, interaction with QC/QA, and meeting study timelines
  • Work with cross functional teams and present assay strategy and data at internal meetings as well as conferences outside
  • Mentor associate scientists or research associates as required

Qualifications

 

  • M.S. in Immunology, Pharmacology, Biology, or a related field, with 5-10 years of relevant immunogenicity assay experience in pharmaceutical, and/or CRO industry; or PhD. with 3-5 years of relevant industrial experience.
  • Must have 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 is required. Previous experience of developing cell-based and ligand binding NAb assays are highly preferred.
  • Must be 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.
  • The candidate must be able to work collaboratively in a multi-cultural fast-paced environment with ability to handle multiple tasks, and set priorities to meet study timelines.
  • Must possess excellent scientific background, solid analytical and trouble-shooting skills.
  • Good written/oral communication and interpersonal skills are required.

Function

Research & Development

Sub Function

Drug Analysis and Formulation

Reports To

Associate Director, Immunogenicity Assessment

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.


Nearest Major Market: Philadelphia

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