Job position at Celldex Therapeutics, Fall River, MA. Deadline is on
- 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.
- 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.
ScienceCast invites all applicants to create a SciCast of their research to attach to their application.