Job position at Celldex Therapeutics, Fall River, MA. Deadline is on

Bioanalytical Scientist

Analytical Chemistry

Job summary
  • Develop, optimize, and validate immunoassays (e.g. ELISA/MSD) under non-GLP and GLPs (Good Laboratory Practices) to support Celldex’ s pipeline.
  •  Work closely with other laboratory scientists, management, and Quality Assurance to ensure timely delivery of nonclinical and clinical results.
  • Review data, help prepare data transfers, and help write reports.
  • Work closely with Quality Assurance to schedule lab, data, and report audits.
  • Author, revise, and review method SOPS.
  • Participate in data analysis.
  • Other general research laboratory duties.

Qualifications:
  • BS/BA/MS/PhD in life sciences.
  • 2-8 years of biotechnology industry experience, preferable in a regulated environment of assay development.
  • Experience in immunoassay development, with particular experience in developing, optimizing, and validating PK, ADA, and IHC assays using animal/human samples.
  • Knowledge and application of regulatory guidances (GLP preferred) to experimental planning and design.
  • GLP and validation experience.
  • Experience with writing, and reviewing analytical SOPs, study protocols, and reports.
  • Strong communication and organizational skills as well as the ability to work
    independently and as part of a team.


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