Associate Director, Chemical Development and Drug Substance Manufacturing
Locations:
South San Francisco, California
Time Type: Full Time
Posted On: Posted 2 Days Ago
Job Requisition ID: R95
About Cytokinetics:
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as treatments for diseases where cardiac muscle performance is compromised. The company is advancing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job Purpose:
The Associate Director (AD) will lead the technical development of small molecule drug substances from IND-enabling studies through commercialization. The role involves leading efforts in synthetic route design, process optimization, control strategy development, and GMP manufacturing activities at external CDMO partners. The AD will collaborate on a cross-functional CMC team and develop a comprehensive CMC development plan to support clinical development.
Responsibilities:
Process Development and Manufacturing:
Manage and mentor internal process chemists and CDMO partners to develop robust and efficient chemical processes.
Lead and direct process development and manufacturing activities at CDMO partners, including tech transfer, process R&D, and scale-up from laboratory to commercial production.
Review and approve cGMP documents such as batch records, change controls, deviations, specifications, validation master plans, and protocols/reports.
Collaborate with the external supply team to coordinate production schedules with CDMO partners to support clinical studies and formulation activities.
Support the development of phase-appropriate drug substance control strategies and specifications.
Lead the design and execution of process characterization and fate/purge studies to establish critical process parameters and process control strategies.
Cross-Functional Collaboration:
Serve as the drug substance lead on cross-functional project teams and collaborate with teams from Analytical Development, Formulation Development, External Manufacturing, and Regulatory Affairs CMC.
Prepare technical development reports and support authoring of clinical regulatory filings (IND/IMPD) and global marketing applications (NDA/MAA).
Ensure timely delivery of drug substance throughout the program’s lifecycle.
Proactively identify risks and communicate effectively with senior leadership within Global Supply Chain and Technical Operations.
Qualifications:
Education:
Ph.D. in Chemistry with 8+ years of experience in small molecule drug substance development or M.S. with 11+ years of relevant experience.
Experience:
Strong expertise in synthetic organic chemistry, process development, scale-up, and GMP manufacturing of drug substances.
Direct experience with CDMO management.
Well-versed in cGMP regulations and quality systems relevant to pharmaceutical development and manufacturing.
Good understanding of analytical methods and ICH guidelines.
Skills:
Excellent problem-solving skills, attention to detail, and the ability to work independently and in a team-oriented environment.
Strong written and verbal communication skills.
Ability to manage multiple priorities and projects effectively.
Ability to travel domestically and internationally.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $190,000 - $232,000 per year.
Final compensation may vary based on internal equity, geographic region, job-related knowledge, skills, and experience.
Commitment to Diversity and Inclusion:
Cytokinetics welcomes candidates from diverse backgrounds. Applicants are encouraged to apply even if they do not meet every qualification. If you are passionate about contributing to Cytokinetics' mission and believe you can add value, you are encouraged to apply.
Important Information:
Cytokinetics upholds scientific integrity, ethics, and patient-centric decision-making. All legitimate offers will come from an official Cytokinetics email domain (cytokinetics.com) after a formal interview process.
Cytokinetics does not:
Conduct interviews through non-standard text messaging applications.
Request personal financial information before an official offer is accepted and verified.
Request candidates to purchase equipment during the hiring process.
If you are unsure about the authenticity of an offer or receive suspicious communication, contact: talentacquisition@cytokinetics.com.
For more information, visit: www.cytokinetics.com
Equal Opportunity Employer
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