Sr. Scientist - Chemical Development and Drug Substance Manufacturing

at  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 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.
We are seeking a highly skilled and motivated Senior Scientist with expertise in small molecule synthesis and process development. The ideal candidate is an innovative thinker with a passion for problem-solving and an ability to drive the development of robust chemical processes from conception of the idea to commercialization. The candidate will play a key role in advancing our drug development programs by leading efforts in synthetic route design, process optimization, and scale-up and manufacturing activities. This position offers an exciting opportunity to contribute to the development of novel therapeutics and to work in a dynamic and collaborative research environment.

QUALIFICATIONS:

• Ph.D. in Organic Chemistry (or related field) with 5+ years of biotech/biopharma industry experience in small molecule drug substance development; or M.S. with 8+ years of relevant experience
• Strong expertise in synthetic organic chemistry, including multi-step synthesis and reaction optimization
• Experience in process development, scale-up, and technology transfer of small molecule APIs from laboratory to manufacturing scale
• Proficiency in analytical techniques commonly used in drug substance characterization
• Familiarity with cGMP regulations and quality systems relevant to pharmaceutical development
• Excellent problem-solving skills, attention to detail, and the ability to work independently and in a team-oriented environment
• Effective communication skills with the ability to convey complex scientific concepts to diverse audiences
  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.

• Design and execute robust and scalable manufacturing routes and processes for small molecule drug substance production, considering safety, quality, and regulatory requirements
• Apply modern synthetic methodologies and techniques to optimize reaction sequences for improved yield, purity, and scalability
• Support design and execution of process characterization and fate/purge studies to establish critical process parameters and define process control strategies
• Leverage internal laboratory capabilities to generate key data and establish proof-of-concept for process development activities
• Collaborate with CDMO partners on development and manufacturing activities including tech transfer, process development, and scale-up from laboratory to pilot plant and ultimately to commercial production
• Characterize process streams, input materials, isolated intermediates, and final products using a variety of analytical techniques, such as HPLC, LC-MS, and NMR to support process R&D activities.
• Maintain accurate and detailed laboratory records in compliance with company policies and regulatory guidelines
• Prepare technical development reports and support authoring of clinical regulatory filings and responses to Health Authority inquiries (e.g., IND, IMPD) as needed
• Collaborate and serve on cross functional project teams with team members from Analytical Development, Formulation Development, and External Manufacturing to develop and execute a CMC strategy that aligns with the clinical development plan
• Collaborate effectively with colleagues from various disciplines including Medicinal Chemistry, Pharmacology, and Regulatory Affairs to achieve project goals
• Provide technical guidance to junior scientists and research associates
• Present research findings and project updates to internal stakeholders and external partners as required