Associate Director or Director – Bioanalytical
| Company | Kymera Therapeutics |
|---|---|
| Location | Belmont, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Master’s, PhD |
| Experience Level | Expert or higher |
Requirements
- Master or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related disciplines with 10+ years (with MSc) / 7+ years (with PhD) of relevant experience in the pharmaceutical industry or at a Bioanalytical CRO.
- Extensive hands-on experience in small molecule regulated (GLP) and discovery bioanalysis with deep understanding of LC-MS/MS method development, troubleshooting and qualification/validation.
- Deep knowledge of regulatory guidelines (FDA, EMA, ICH M10 etc.) for Regulated Bioanalysis and GLP practices is critically required.
- Proven track records of scientific achievements in LC-MS quantitative bioanalysis as evident by publications and presentations.
- Experience of delivery of bioanalytical work blocks via GLP and non-GLP CROs and expertise in managing CROs to support GLP and clinical studies to help advancing projects to different stages.
- Proven track record of working in cross-functional project teams in Discovery, Preclinical [GLP & non-GLP], and Clinical Bioanalytical study support.
- Strong analytical, organizational, and communication skills.
Responsibilities
- Serve as the bioanalytical (BA) project lead and effectively interface with internal (Pharmacology, Safety, Clin. Pharm, Clin. Ops, DMPK, Quality) and external CRO partners to deliver bioanalytical strategy and execution in support of Kymera’s project portfolio.
- Identify and maintain relationships with high quality CROs to meet project demands for both discovery and development BA support.
- Effective and timely execution in collaboration with CROs: Develop and validate bioanalytical methods for preclinical and clinical study support. Ensure excellence in study stewardship, bioanalytical data delivery, and analysis.
- Conduct detailed review and ownership of all bioanalytical data and reports (GLP and non-GLP).
- Adhere strongly to all quality standards, and collaborate with QA (Quality Assurance) to ensure compliance with all bioanalytical workflows.
- Author and review relevant sections of regulatory and internal documents.
Preferred Qualifications
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No preferred qualifications provided.