Job Description

Our client is seeking a talented and passionate Senior Scientist to join their dynamic Analytical and Formulation Development Group. The successful applicant will work in multi-disciplinary teams and will be responsible for analytical support of formulation development, analytical characterization and stability studies for drug substances and drug products to support our clinical development programs.

Working knowledge of GMP regulations, Compendia, and common industry practices in the US and EU is desirable.

The ideal candidate will have experience developing Phase 1/2 stage drugs, a strong background in analytical chemistry and analytical methodology, understanding of drug product development process, and excellent communication and organizational skills.

Essential Functions:

• Oversee and execute analytical method development, both internal and at CRO, analytical characterization testing, and in-process control testing.
• Lead technical projects spanning multiple initiatives in small molecule analytical and formulation development for discovery projects and CMC support.
• Contribute to the strategy and execution of in-house and outsourced stability studies for drug substances and parenteral drug products.
• Perform a batch record review, a trend analysis, and a shelf-life assessment for investigational new drugs and clinical development candidates.
• Collaborate with peers and work effectively in an energized, fast‐paced, cross‐functional, and result-oriented research team environment to deliver the objectives of the client in a timely and cost-efficient manner that meets quality requirements.
• Provide strong technical expertise and hands-on experience in analytical methodologies common to the pharmaceutical industry (e.g. HPLC/UPLC, GC, MS, KF).
• Oversee the maintenance and troubleshooting of analytical instruments.
• Train junior personnel.
• Maintain good laboratory practice, safety, and record keeping.
• Author internal reports, methods, and protocols, and contribute to regulatory submissions.
• Interact closely with Biology, Chemistry, CMC, and management to provide project updates, workflow, and contributions to timelines/budget.

Education and Experience:

• Ph.D. in chemistry with 1-3 years of pharma/biotech experience or M.S. with 4-8 years of experience in a related science field is required.
• Established background in analytical characterization for drug substance, intermediates, and drug product.
• Good understanding of formulation development for parenteral products, lyophilization processes, and the delivery system development.
• Having a high degree of organizational capabilities for both data and experimental scheduling.
• Experience with managing and mentoring of junior scientific staff members.