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Senior Scientist, Product Development

San Mateo, CA 94404

Posted: 07/21/2026 Employment Type: Direct Hire Industry: Scientific Job Number: 12743 Pay Rate: $118k - $160k Remote Friendly: Onsite

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.

Job Requirements


Nice to Have Skills:
  • Experience with lipid formulations, liposomes, or related drug delivery systems.
  • Knowledge of inhalation delivery technologies and aerosol characterization techniques.
  • Familiarity with homogenization, lyophilization, or sterile manufacturing processes.
  • Prior work on drug-device combination products.


Preferred Education & Experience:
  • Ph.D. or Master's degree in Analytical Chemistry, Chemistry, Biochemistry, or a related discipline.
  • 5-10 years of relevant industry experience, particularly in late-stage development.
  • Hands-on experience in managing complex analytical method development and stability programs.


Other Requirements:
  • Ability to manage projects independently, liaising effectively with external partners.
  • Willingness to travel occasionally for collaborations or site visits.
  • Commitment to quality, compliance, and innovation in pharmaceutical development.

Meet Your Recruiter

Jay Hite
Recruiter, Account Manager

As a Recruiter at Compass, Jay enjoys meeting job seekers and helping them to find new and exciting opportunities. He enjoys the process of getting to know candidates and learning all about their experience and what their future goals are. Jay feels the excitement of his candidates and is passionate about helping to find a fit both culturally and professionally. 

When Jay isn’t working, he enjoys bike rides, trying out new foods, tequila tasting and watching movies.  

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About San Mateo, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Mateo, California area today! Located in the heart of the Bay Area, San Mateo offers a perfect blend of picturesque landscapes, bustling tech industry, and a rich cultural scene. From the iconic Coyote Point Park to the bustling downtown with its array of dining options, art galleries, and theaters, there is something for everyone here. With proximity to professional sports teams like the San Francisco Giants and Warriors, as well as easy access to the stunning Half Moon Bay and Pacific Ocean beaches, San Mateo provides a unique backdrop for career growth and personal enjoyment. Don't miss out on the chance to make your mark in this dynamic and inviting community!