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Director, Immunogenicity Assessment

Date: Jan 11, 2022

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!

 

Teva’s 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.
 

Job Description

We are seeking a highly talented and motivated Director – Immunogenicity Risk Assessment within Specialty Bioanalytics in our West Chester, PA location. We are looking for an experienced individual with a background and hands-on in method development, validation and implementation for Immunogenicity risk assessment of Biologics and Peptide Therapeutics. This position reports to the Senior Director and plays a critical role in the drug development from early to late stages, including regulatory submission.

 

Essential Job Duties and Responsibilities: 

•    Lead the Immunogenicity Risk Assessment group, hire and retain talents, develop the Immunogenicity members in scientific and professional growth
•    Establish strategy for Immunogenicity Risk Assessment, represent the Immunogenicity group and interact with internal (Clinical, Non-Clinical, Regulatory Affairs, Clinical Pharmacology, CMC, Quality Assurance) and external (Regulatory Agencies, CROs, partners) groups
•    Serve as Project Representative for Teva Biologics and Generic Peptide programs
•    Review and approve study reports, methods, and submission documents (Integrated Immunogenicity Report, Investigation Brochures, IND, BLA and ANDA)
•    Ensure resources are available for on-time completion of projects under allocated budgets

 

*Relocation Package Available 

Qualifications

What you will bring to the role:
At  least a Master’s Degree in Immunology, Biology, Biochemistry or related discipline
10+ years of relevant pharma/biotech/CRO industry experience with deep technical experience in biologics drug development.
•    At least 5 years’ experience in anti-drug antibody and neutralizing antibody method development is required 
•    At least 3 years’ experience working with different regulations (GLP, GCP) 
•    A minimum of 3 years’ experience e in leading managers for groups of scientists in clinical drug development setting is necessary 

 

Preferred Qualifications

PhD. in Immunology, Biology, Biochemistry or related discipline

Familiarity with in silico and in vitro approaches to predict the potential immunogenicity of proteins and peptides

Excellent written and verbal communications and interpersonal skills,

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

Sr Director Specialty Bioanalytics

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.

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.


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