Associate Director Chemical Development and Drug Substance Manufacturing

Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Associate Director Chemical Development and Drug Substance Manufacturing

At Cytokinetics each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious compassionate and collaborative individuals who are driven to make a positive impact.

We are seeking a highly skilled and motivated Associate Director with expertise in small molecule process development and manufacturing to join our CMC team. In this role you will be responsible for the technical development of small molecule drug substances from INDenabling studies through commercialization.

You will play a key role in advancing our drug development programs by leading efforts in synthetic route design process optimization control strategy development and scaleup and GMP manufacturing activities at external CDMO partners. You will serve on a crossfunctional CMC team and develop a comprehensive CMC development plan that supports clinical development.

This position offers an exciting opportunity to contribute to the development of novel therapeutics and to work in a dynamic and collaborative research environment. This position is integral to the advancement of Cytokinetics growing portfolio of drug candidates.

Responsibilities:

• Manage and mentor process chemists internally and at contract development and manufacturing organization (CDMO) partners to develop robust efficient and safe chemical processes.

• Lead and direct development and manufacturing activities at CDMO partners including tech transfer process R&D and scaleup from the laboratory to the pilot plant and then to commercial production.

• Support the selection of CDMO partners by providing the technical evaluation of process R&D and GMP manufacturing capabilities. Participate in site visits to support the selection process as needed.

• Review and approve cGMP documents including batch records change controls deviations specifications validation master plans and validation protocols/reports

• Enable selection of CDMO partners by authoring the technical sections of requests for proposal reviewing the proposals and supporting Cytokinetics external supply team with price negotiations.

• Collaborate with Cytokinetics external supply team to coordinate production schedules at CDMO partners to support nonclinical and clinical studies and formulation development activities.

• Work with the Cytokinetics external supply team and CDMO partners to facilitate the purchase of custom raw materials for drug substance manufacturing.

• Support the development of phase appropriate drug substance control strategies. Identify drug substance critical quality attributes (CQAs) and develop specifications for starting materials and intermediates which ensure drug substance of suitable quality is consistently produced.

• Lead and direct the design and of process characterization and fate/purge studies to establish critical process parameters and define process control strategies.

• Serve as the drug substance lead on cross functional project teams and collaborate with team members from Analytical Development Formulation Development External Manufacturing and Regulatory Affairs CMC to develop and execute a CMC strategy that aligns with the clinical development plan.

• Prepare technical development reports and support authoring of clinical regulatory filings (IND/ IMPD) and global marketing applications (NDA/MAA). Author responses to address Health Authority inquiries.

• Work effectively with the crossfunctional CMC team to ensure timely delivery of drug substance throughout the programs lifecycle.

• Implement best practices and drive continuous improvements in the drug substance development process through technological innovation and problemsolving.

• Proactively identify risks and communicate effectively with senior leadership within Global Supply Chain and Technical Operations.

Qualifications:

• Ph.D. in chemistry with 8 years of pharmaceutical/biotech industry experience in small molecule drug substance development; or M.S. with 11 years of relevant experience.

• Strong expertise in synthetic organic chemistry and experience in process development scaleup and GMP manufacturing of drug substances.

• Strong understanding of solidstate properties of small molecules

• Direct experience with management of CDMOs

• Wellversed with cGMP regulations and quality systems relevant to pharmaceutical development and manufacturing.

• Good understanding and knowledge of analytical methods and associated ICH guidelines

• Experience authoring CMC sections of regulatory filings

• Thorough understanding of the drug development process from initial process R&D through commercialization

• Excellent problemsolving skills attention to detail and the ability to work independently and in a teamoriented environment

• Excellent written and verbal communication skills

• Excellent interpersonal skills and ability to effectively manage multiple priorities and projects

• Ability to travel domestically and internationally

Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.

Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer