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Senior Scientist, Product Development

Compass Consulting

San Mateo, CA

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JOB DETAILS
SKILLS
Aerosols, Analysis Skills, Analytical Chemistry, Analytical Development, Analytical Method Development, Analytical Method Validation, Biochemistry, Business Strategy, Communication Skills, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Drug Development, FDA (Food and Drug Administration), High Performance Liquid Chromatography (HPLC), Identify Issues, Industry Standards, Inhalation Drugs, Interpersonal Skills, Laboratory, Laboratory Management, Liquid Chromatography-Mass Spectrometry (LC-MS), Maintain Compliance, Manufacturing Requirements, Manufacturing/Industrial Processes, Neonatology, New Drug Application, Presentation/Verbal Skills, Process Improvement, Product Development, Project Execution, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Research & Development (R&D), Strategic Planning, Time Management, Writing Skills
LOCATION
San Mateo, CA
POSTED
30+ days ago

Our client is dedicated to revolutionizing care for acute and critically ill patients by developing innovative inhaled drug/biologic and device combination products. They are seeking a talented Senior Scientist to drive late-stage product development and regulatory excellence.

This is your opportunity to be part of a passionate, expert-driven team steering medical innovation that has the potential to change lives. Bring your expertise in biologic and device combination products, analytical development, and regulatory strategy to a company at the forefront of neonatal care breakthroughs.


What you'll do:
  • Lead pharmaceutical development activities, including data generation, product characterization, and process optimization.
  • Prepare and review regulatory submission documents such as INDs, BLAs, and NDAs, ensuring full compliance with cGMP standards.
  • Manage analytical method development, validation, and transfer for lipids, proteins, and peptides, with a focus on robustness and industry standards.
  • Design and oversee stability studies to establish product shelf life for clinical and commercial use.
  • Collaborate closely with external CDMOs and CMO partners to ensure timely, high-quality project execution.
  • Work cross-functionally with R&D, Manufacturing, Regulatory, and Quality teams to align development strategies with regulatory requirements and business goals.
  • Troubleshoot complex analytical issues and implement corrective actions to maintain project momentum.


Required Skills:
  • 5-10 years of late-stage product development experience in pharmaceuticals.
  • Proven expertise in authoring CMC sections for regulatory agencies such as FDA and EMA.
  • Strong background in analytical chemistry, biochemistry, or related fields (M.Sc. or Ph.D.).
  • Deep understanding of regulatory processes and submission preparation.
  • Experience managing external labs and CDMOs.
  • Knowledge of cGMP practices and sterile manufacturing processes.
  • Proficiency with analytical techniques such as HPLC, LC-MS, G.C., particle size analysis, and aerosol characterization.
  • Excellent communication skills—written, verbal, and interpersonal.

About the Company

C

Compass Consulting

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