Cytokinetics

Cytokinetics

Director, Chemical Development

South San Francisco, California · Director

Sponsorship not specified$218k-$254kDetected 29 days ago
ComplianceSupply ChainProcess ImprovementIntellectual PropertyClinical TrialsGMPFDA RegulatoryExperimental DesignLeadershipCommunicationProblem SolvingMentoringPublic SpeakingOrganizational SkillsRegulatory Affairs

About the role

  • This role is expected to influence strategic decisions, identify and mitigate technical and supply risks, and communicate effectively with senior leadership.
  • It offers an exciting opportunity to contribute to the advancement of Cytokinetics' growing portfolio of novel therapeutics.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Responsibilities

  • Provide technical leadership, mentorship, and people leadership for internal scientists, while building organizational capability within Chemical Development and effectively leading CDMO partners.
  • Lead process R&D activities at CDMO partners and provide technical oversight for scale-up and tech transfer from the laboratory to the pilot plant and, as appropriate, to commercial manufacturing.
  • Lead the technical evaluation and selection of CDMO partners by assessing process R&D and GMP manufacturing capabilities, participating in site visits, and influencing decisions that support program and portfolio needs.
  • Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plans, and validation protocols/reports.
  • Author technical sections of requests for proposal, review proposals, and partner with the Cytokinetics external supply team to support CDMO selection and contracting discussions.
  • Partner with the Cytokinetics external supply team to coordinate production schedules at CDMO partners in support of non-clinical and clinical studies and formulation development activities.
  • Partner with the Cytokinetics external supply team and CDMO partners to support sourcing and timely availability of custom raw materials for drug substance manufacturing.
  • Lead the development of phase-appropriate drug substance control strategies, including identification of critical quality attributes (CQAs) and establishment of specifications for starting materials and intermediates to ensure consistent product quality.
  • Drive development of safe, robust, scalable, and cost-effective manufacturing processes, including evaluation of process safety and scale-up risks to support clinical development and commercial readiness.
  • Lead the design and execution of process characterization and fate/purge studies to establish critical process parameters and define process control strategies.

Requirements

  • Ph.D. in chemistry with 12+ years of pharmaceutical/biotech industry experience in small molecule drug substance development
  • or M.S. with 15+ years of relevant experience.
  • Strong understanding of the solid-state of small molecules.
  • Experience authoring CMC sections of regulatory filings.
  • Thorough understanding of, and demonstrated experience across, all phases of drug development from initial process R&D through commercialization.
  • Excellent problem-solving skills, attention to detail, and the ability to work both independently and collaboratively.
  • Excellent written and verbal communication skills, with the ability to communicate effectively across technical, cross-functional, and senior leadership audiences.
  • Ability to travel domestically and internationally.
  • Strong expertise in synthetic organic chemistry and experience in process development, scale-up, and GMP manufacturing support for drug substances.
  • Direct, hands-on experience leading CDMOs and ensuring high-quality execution and delivery.
  • Well-versed with cGMP regulations and quality systems relevant to pharmaceutical development and manufacturing.
  • Demonstrated ability to lead complex cross-functional initiatives, influence senior stakeholders, and represent the function effectively in high-level forums.
  • Good understanding of analytical methods and associated ICH guidelines.
  • Strong interpersonal and organizational skills, with the ability to manage multiple priorities, complex projects, and cross-functional stakeholders effectively.
  • Prior experience mentoring, developing, and managing scientists or matrix teams is preferred.

Compensation

  • In the U.S., the hiring pay range for fully qualified candidates is $217,710 - $253,995 per year.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Benefits

  • Oversee preparation of technical development reports and contribute to authoring clinical regulatory filings (IND/IMPD) and global marketing applications (NDA/MAA), including responses to Health Authority inquiries.

Company info

  • We are seeking a highly skilled and motivated Director with expertise in small molecule process development and manufacturing to join our CMC team.

Equal opportunity

  • www.cytokinetics.com
  • Cytokinetics is an Equal Opportunity Employer
Apply directly at Cytokinetics →Create a free account for alerts like thisView Cytokinetics immigration profile

This listing is sourced directly from Cytokinetics's careers page and normalized into a canonical job model.