Celldex Therapeutics

Senior Associate Scientist/Scientist I

US-MA-Needham

Overview

The Clinical Assays department is a regulated laboratory providing bioanalytical testing (PK and Immunogenicity) in support of Celldex clinical trials with novel Immuno-oncology therapies and Antibody-Drug Conjugates. We are seeking a Bioanalytical Scientist to perform a variety of functions related to assay development/validation, clinical sample management and sample bioanalysis. The qualified candidate will be an important member of the Clinical Assays team and contribute greatly to our understanding of how these fascinating new therapies work in the treatment of cancer.

Responsibilities

  • Develop, optimize and validate novel immunoassays in biological matrix to support Celldex's pipeline.
  • Troubleshoot and investigate assays/reagents in case of performance issues.
  • Work with internal and external vendors to support reagent needs if required.
  • Review and interpret bioanalytical data and maintain a database of results.
  • Follow corporate and departmental SOPs involving safety, sample management, data entry, data review and maintenance of a GLP laboratory and associated equipment.
  • Analysis of clinical trial samples in support of Celldex Clinical Trials as required.
  • Author, revise and review departmental procedures as necessary.

Qualifications

Required Skills:

  • Experience in LBA development, validation and sample analysis (e.g. ELISA or MSD) in quantitative (pharmacokinetic) and qualitative (e.g. immunogenicity or anti-drug antibody assays)
  • Strong attention to detail with a critical eye or direct experience in error analysis
  • Experience in the application of statistical methods in decision making a plus.
  • Strong communication and organizational skills as well as the ability to work both independently and as part of a team.

Education/Experience:

  • BS or MS in Biotechnology, Chemistry, Biological Sciences or a related field.
  • 3+ years experience working in a regulated environment per GLP, GMP or CLIA required
  • Experience working with electronic database or LIMS system is an advantage.

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