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.
Drive 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.
Manage 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
Cytokinetics is an Equal Opportunity Employer
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