Associate Director, Chemical Development and Drug Substance Manufacturing

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 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.

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.

Associate Director, Chemical Development and Drug Substance Manufacturing

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 IND-enabling 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 scale-up and GMP manufacturing activities at external CDMO partners. You will serve on a cross-functional 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 scale-up 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 non-clinical 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 execution 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 cross-functional CMC team to ensure timely delivery of drug substance throughout the program’s lifecycle.
• Implement best practices and drive continuous improvements in the drug substance development process through technological innovation and problem-solving.
• 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, scale-up, and GMP manufacturing of drug substances.
• Strong understanding of solid-state properties of small molecules
• Direct experience with management of CDMO’s
• Well-versed 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 problem-solving skills, attention to detail, and the ability to work independently and in a team-oriented 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
  
  

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 our General Data Protection Regulation (GDPR) policy PRIOR 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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here Are Some Ways To Check For Authenticity

• We do not conduct job interviews through non-standard text messaging applications
• We will never request personal information such as banking details until after an official offer has been accepted and verified
• We will never request that you purchase equipment or other items when interviewing or hiring
• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
  
  

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

In the U.S., the hiring pay range for fully qualified candidates is $190,000-$232,000 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.