Senior Scientist I
Cytokinetics
August 21, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Responsibilities:
- Design and execute robust, scalable manufacturing routes/processes for small-molecule drug substance production, considering safety, quality, and regulatory requirements.
- Apply modern synthetic methodologies to optimize reaction sequences for yield, purity, and scalability.
- Support process characterization and fate/purge studies to establish critical process parameters and process control strategies.
- Use internal lab capabilities to generate key data and establish proof-of-concept for process development.
- Collaborate with CDMO partners on tech transfer, process development, and scale-up from lab to pilot plant and commercial production.
- Characterize process streams, inputs, intermediates, and final products using HPLC, LC-MS, NMR, and other analytical techniques.
- Maintain accurate laboratory records in compliance with company policies and regulatory guidelines.
- Prepare technical development reports; support clinical regulatory filings and responses to Health Authority inquiries (e.g., IND, IMPD) as needed.
- Serve on cross-functional teams to develop/execute a CMC strategy aligned with clinical plans.
- Provide technical guidance to junior scientists; present updates to internal/external stakeholders.
Qualifications:
- Ph.D. in Organic Chemistry (or related) with 5+ years biotech/biopharma small-molecule drug substance experience; or M.S. with 8+ years relevant experience.
- Strong synthetic organic chemistry skills (multi-step synthesis, reaction optimization).
- Experience in process development, scale-up, and technology transfer of small-molecule APIs.
- Proficiency in drug substance analytical techniques.
- Familiarity with cGMP regulations and pharmaceutical quality systems.
- Strong problem-solving, attention to detail, and independent teamwork.
- Effective communication skills for diverse audiences.
- Design and execute robust, scalable manufacturing routes/processes for small-molecule drug substance production, considering safety, quality, and regulatory requirements.
- Apply modern synthetic methodologies to optimize reaction sequences for yield, purity, and scalability.
- Support process characterization and fate/purge studies to establish critical process parameters and process control strategies.
- Use internal lab capabilities to generate key data and establish proof-of-concept for process development.
- Collaborate with CDMO partners on tech transfer, process development, and scale-up from lab to pilot plant and commercial production.
- Characterize process streams, inputs, intermediates, and final products using HPLC, LC-MS, NMR, and other analytical techniques.
- Maintain accurate laboratory records in compliance with company policies and regulatory guidelines.
- Prepare technical development reports; support clinical regulatory filings and responses to Health Authority inquiries (e.g., IND, IMPD) as needed.
- Serve on cross-functional teams to develop/execute a CMC strategy aligned with clinical plans.
- Provide technical guidance to junior scientists; present updates to internal/external stakeholders.
Qualifications:
- Ph.D. in Organic Chemistry (or related) with 5+ years biotech/biopharma small-molecule drug substance experience; or M.S. with 8+ years relevant experience.
- Strong synthetic organic chemistry skills (multi-step synthesis, reaction optimization).
- Experience in process development, scale-up, and technology transfer of small-molecule APIs.
- Proficiency in drug substance analytical techniques.
- Familiarity with cGMP regulations and pharmaceutical quality systems.
- Strong problem-solving, attention to detail, and independent teamwork.
- Effective communication skills for diverse audiences.