Biological Researcher II - West Chester, PA
West Chester, United States, 19380
Who we are
The opportunity
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. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
We are seeking a highly motivated individual with hands-on experience in anti-drug antibody (ADA) and neutralizing antibody (NAb) assays in support of immunogenicity assessment of biologic drug development. 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.
How you’ll spend your day
- Participate in ADA and/or NAb method development in support of preclinical and clinical immunogenicity assessment
- Conduct method validation and sample analysis in a regulated environment, including but not limited to planning assay runs in Watson LIMS, performing the assay, and summarizing data
- Perform data analysis and transfer using Watson LIMS, and assist in preparation of assay validation report or sample analysis report
- Maintain laboratory records for compliance/regulatory audits
- Procure, inventory, and track assay reagents
- Work in collaboration with sample management team to maintain sample chain of custody records
Your experience and qualifications
- Bachelor of Science in Immunology, Pharmacology, Biology, or a related field, with at least five years of relevant industry experience, or Master of Science in Immunology, Pharmacology, Biology, or a related field, with at least three years of relevant industry experience in the pharmaceutical, biotechnology, and/or CRO industry, including expanded levels of responsibility or a range of experiences
- Working knowledge of GLP, GCP, SOPs, and regulatory requirements is required
- Experience with ligand binding assays, cell-based assays, PK, ADA and/or NAb method development and validation, and execution of immunoassays for immunogenicity assessment
- Proficiency in Excel and laboratory data management systems, with a strong preference for Watson LIMS
- Experience using SoftMax Pro and MSD Discovery Workbench for data analysis, data summary, data transfer, and/or report writing is a plus
- Ability to work collaboratively in a diverse, fast-paced environment, with strong multitasking skills
- Excellent communication and interpersonal skills
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
Already Working @TEVA?
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Teva’s Equal Employment Opportunity Commitment
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Nearest Major Market: Philadelphia