Assoc Dir, Immunogenicity Assessment

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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

 Associate Director – cellular Immunogenicity within Specialty Biologics in our West Chester, PA location. We are looking for an experienced individual with a background and hands-on in in vitro cell based Immunogenicity method development, validation and implementation. This position reports to the Director – Immunogenicity and plays a critical role in the development of biologics from early to late stages, including regulatory submission.

 

 

Responsibilities

• Planning, coordinating and leading a subgroup to conduct activities for cellular immunogenicity assessment including method development, assay validation, sample analysis, and data transfer
• Serve as Project Representative for Teva Biologics programs
• Involve in the writing and reviewing of regulated documents for ANDA submissions (Immunogenicity study reports, Section 5354 etc…)
• Serve as Study Leader or Principal Investigator for immunogenicity assessment-related studies
• Evaluate cellular immunogenicity results and monitor on-time completion of tasks and projects
• Undertake long-term and short-term planning and supervision of team members
• Conduct technical meetings for internal or external representations
• Select and monitor CROs, projects and costs as needed

Qualifications

• Required: Minimum MS degree  in a scientific field, preferable Biology, Biochemistry or Pharmacology
• Preferred: PhD in a related scientific field, preferable Biology, Biochemistry or Pharmacology
• Required: 5 years pharma/biotech/CRO industry experience
• Required: Hands-on knowledge of BD flow cytometers, including cytometer setup, maintenance, and experiment execution and FlowJo or FCS Express software is necessary.
• Required: Minimum 3 years’ experience working in a regulated environment (GLP, GCLP).
• Required: Prior leadership experience leading a small group and managing multiple projects.
• Preferred: Familiarity with different ligand binding assay platforms, Watson LIMS and ELN systems is a plus.
• Preferred: Experience in clinical drug development is beneficial.

Function

Sub Function

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