about 1 month ago
Title: Senior Manager/Associate Director Preclinical R&D and Bioanalytics
5 days a week in office
Salary: Dependent upon title, but slated for 130k-200k
- Manage a team of bioanalytical scientists
- Guide the development, optimization, and validation of immunoassays (e.g., ELISA, MSD) under non-GLP and GLP (Good Laboratory Practice) to support my client's pipeline.
- Work closely with analysts, senior management, and Quality Assurance to ensure timely delivery of nonclinical and clinical results.
- Review data per GLPs, prepare data transfers, and write reports to be included as part of regulatory submissions.
- Work closely with Quality Assurance group to schedule lab, data, and report audits.
- Track and ensure the resolution of CAPAs.
- Follow established protocols; author, revise, and review method SOPs.
- Data analysis and presentation of data.
- Management experienced highly preferred
- Knowledge and application of regulatory guidance (GLP preferred) to experimental planning and design.
- Experience in immunoassay development, with particular experience in developing, optimizing, and validating PK and ADA assays using animal/human samples according to FDA guidance documents.
- GLP (21 CFR Part 11 and Part 58) experience and validation
- Experience in writing and reviewing analytical SOPs, study protocols, and reports.
- Experience in the aseptic maintenance of cell lines in culture a plus.
- Experience in flow cytometry a plus.
- BS/BA degree in Biology or a similar discipline
- 5+ years of Biotech industry experience in a regulated environment.