Director, Analytical Development & CMC Compliance

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.

The Director, Analytical Development & CMC Compliance is a strategic technical subject matter expert (SME) supporting analytical development roadmap establishment, analytical process optimization, and continuous improvement. The position acts as a technical leader and subject matter expert (SME) in CMC analytical development strategy from tox to Phase 1 through Phase 3 to support global regulatory filings (IND, IMPD, NDA, MAA, etc.). Leads the development, qualification, and lifecycle management of analytical methods and control strategies aligned with ICH guidelines and evolving regulatory expectations. Ensures robust, compliant analytical control strategies to enable successful clinical progression, registration, and commercial success. The position works closely with Manufacturing, Process Development, Regulatory CMC, and Quality Assurance to ensure compliance with global regulatory standards (e.g., FDA, EMA, ICH) and to enable successful product approvals.

Responsibilities

1. Technical Leadership

• Execute analytical development strategies aligned with corporate objectives, program requirements, Analytical Target Profile (ATP) and Quality Target Product Profile (QTPP), in close collaboration with line management and GSC&TO leadership.
• Lead establishment and maintenance of Analytical Development standards, integrating all best in industry guidelines and Health Authority regulations.
• Drives the design and implement robust, phase-appropriate and robust analytical approaches to enable successful clinical development and registration.
• Provide technical leadership and mentorship, influencing cross-functional decisions and advancing analytical and compliance excellence within CMC Analytical.
• Serve as a technical and regulatory subject matter expert, supporting inspections and audits and contributing to inspection readiness.
  
  2. Analytical Development

• Lead analytical development activities of assigned programs, characterization studies, comparability assessments, and stability strategies. Manages the development, qualification, validation, and lifecycle management of analytical methods and control strategies.
• Manage GMP testing for raw materials, in-process, drug substance, and drug product.
• Oversee development activities at external laboratories and CDMOs ensuring compliance and timeline.
• Lead analytical transfer activities supporting drug substance and drug product manufacturing process transfer and scale up.
• Serve as analytical subject matter expert in due diligence activities.
• Ensure timely release testing and stability testing to meet development and production timelines.
• Manage change control, OOS/OOT investigations, CAPA implementation, and deviation management.
• Ensure compliance with ICH guidelines (e.g., Q2, Q14), USP, EP, JP  and other compendial standards.
• Support regulatory submissions (IND, IMPD, NDA, MAA, JNDA, etc.) including authoring/ reviewing high-quality CMC sections and lead responses to regulatory questions (RTQs).

     3. Quality & Regulatory Compliance

• Serve as Analytical method and Quality Control SME during regulatory inspections (e.g., FDA, EMA, PMDA).
• Support inspection readiness and continuous improvement culture.
• Ensure data integrity and GMP documentation practices.

     4. Budget & Resource Management

• Support development and execution of program budgets (capital and operational).
• Optimize internal vs. external testing strategies.
• Evaluate and implement advanced analytical technologies.

Qualifications

Education

• Ph.D. or equivalent in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (preferred)

Experience

• 10+ years in pharmaceutical/biotech analytical development with demonstration of progressive technical leadership roles and global experience
• Demonstrated experience supporting INDs, NDAs/MAAs
• Demonstrated experience with stage gate development strategies.
• Direct experience interacting with global health authorities

 Technical Expertise

• Chromatography (HPLC, UPLC, GC)
• Mass spectrometry
• Stability studies and degradation pathways
• Method development, validation, transfer, and lifecycle management
• Proficient in writing technical reports and AD/QC sections of CMC regulatory documents
• GMP laboratory systems (Veeva, LIMS, Empower)
• Analytical development experience in drug substances and drug products

Core Competencies

• Strategic thinking and enterprise leadership
• Strong regulatory and compliance acumen
• Operational excellence mindset
• Excellent interpersonal, communication and decision-making/influencing skills
• Expert knowledge of cGMP and GLP compliance and regulations and experienced in manufacturing batch record review, product specifications, stability programs and other AD/QC activities
• Demonstrated ability to manage external contractors to meet or exceed Company goals
• Risk assessment and problem-solving expertise
• Exceptional communication and mentorship skills
  
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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