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Science Jobs in San Mateo, CA

Senior Scientist, Product Development

Compass Consulting
  • San Mateo, CA
  • Instant Apply
1 day ago

Job Description


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.

Numbers & Facts

LocationSan Mateo, CA

Skills

  • Aerosolsunmatched
  • Analysis Skillsunmatched
  • Analytical Chemistryunmatched
  • Analytical Developmentunmatched
  • Analytical Method Developmentunmatched
  • Analytical Method Validationunmatched
  • Biochemistryunmatched
  • Business Strategyunmatched
  • Communication Skillsunmatched
  • Corrective Actionunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Drug Developmentunmatched
  • FDA (Food and Drug Administration)unmatched
  • High Performance Liquid Chromatography (HPLC)unmatched
  • Identify Issuesunmatched
  • Industry Standardsunmatched
  • Inhalation Drugsunmatched
  • Interpersonal Skillsunmatched
  • Laboratoryunmatched
  • Laboratory Managementunmatched
  • Liquid Chromatography-Mass Spectrometry (LC-MS)unmatched
  • Maintain Complianceunmatched
  • Manufacturing Requirementsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Neonatologyunmatched
  • New Drug Applicationunmatched
  • Presentation/Verbal Skillsunmatched
  • Process Improvementunmatched
  • Product Developmentunmatched
  • Project Executionunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Regulatory Submissionsunmatched
  • Research & Development (R&D)unmatched
  • Strategic Planningunmatched
  • Time Managementunmatched
  • Writing Skillsunmatched

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