Senior Manager, CMC Analytical Chemistry

Cytokinetics; South San Francisco (CA); On-site; USD 182,000 - 212,000; Full time

Job summary

Cytokinetics, a cardiovascular biopharmaceutical company, seeks a Senior Manager, CMC Analytical to lead analytical development and QC activities for late-stage programs and commercial manufacturing. You will manage CROs/CDMOs, drive method development, validation, and regulatory support within a GMP framework.

The role requires strong scientific and communication skills, cross-functional collaboration, and a focus on quality and compliance in a fast-paced environment.

Qualifications

• BS in analytical chemistry or related field required; MS/PhD preferred.
• 5+ years in analytical development and/or QC.
• Experience managing external labs and manufacturing partners.
• GMP change controls and OOS investigations experience.
• Regulatory submission experience (IND/IMPD/NDA).

Responsibilities

• Act as SME for analytical development and QC activities.
• Oversee CROs/CDMOs for method development, validation, transfer, and testing.
• Review data, protocols, reports for GMP compliance and data integrity.
• Provide analytical support to drug substance and drug product teams.
• Support regulatory submissions and lifecycle management.
• Prepare and approve analytical protocols, reports, specs, and CMC sections.

Skills

Analytical development

Quality control

GMP compliance

Project management

Technical troubleshooting

Regulatory submissions

Communication skills

Independent work

CRO/CDMO management

Education

BS in analytical chemistry or related

MS or PhD preferred

Job description

Cytokineticsis a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

We welcome exceptional individuals to join us in our mission to develop potential medicines to improve the health span of people with cardiovascular diseases of impaired muscle function. We are seeking a highly skilled and motivated Analytical Chemist with expertise in late-stage analytical development and commercial manufacturing support. The ideal candidate is an experienced analytical professional with proven track records in Analytical Development, Quality Control, and technical support to Drug Substance and Drug Product manufacturing processes. This position offers an exciting opportunity to contribute to the development of novel therapeutics, support the launch of a new commercial product, and to work in a dynamic and collaborative cross functional team environment.

Job Purpose

The Senior Manager, CMC Analytical, is responsible for the execution and oversight of analytical development and quality control activities supporting late-stage development and commercial manufacturing. This role serves as the primary analytical lead for assigned programs and is accountable for the timely execution of analytical method development, validation, transfer, and quality control activities through internal and external partners.

The incumbent will manage contract laboratories and manufacturing partners to ensure high-quality, compliant analytical deliverables that support product development, regulatory submissions, commercial supply, stability programs, and lifecycle management. This role requires strong technical expertise, operational excellence, and a quality-focused mindset to ensure successful execution of analytical and quality control activities in a GMP environment.

Responsibilities

• Serve as the analytical subject matter expert (SME) for analytical development and quality control activities supporting assigned programs.
• Manage and oversee CROs, contract testing laboratories, and CDMOs to ensure timely execution of analytical method development, validation, transfer, troubleshooting, and testing activities.
• Review analytical data, protocols, reports, and technical documents to ensure scientific quality, data integrity, and compliance with GMP and regulatory requirements.
• Provide analytical support to drug substance, drug product, and manufacturing teams to address development and commercial manufacturing needs.
• Execute analytical activities required to support regulatory submissions, post-approval changes, and lifecycle management.
• Prepare, review, and approve analytical protocols, reports, specifications, validation documents, and CMC sections of regulatory filings.
• Lead analytical change controls, deviations, laboratory investigations, and OOS/OOT investigations, ensuring timely resolution and implementation of effective CAPAs.
• Manage stability studies and reference standard qualification and requalification programs.
• Monitor analytical project timelines, identify risks, and drive issue resolution to maintain project and manufacturing schedules.
• Support quality audits, supplier audits, and regulatory inspections by providing analytical documentation and technical responses.
• Ensure analytical activities are conducted in compliance with current GMP regulations, ICH guidelines, internal procedures, and industry best practices.
• Contribute to continuous improvement initiatives to enhance analytical operations, documentation quality, and compliance performance.
• Support quality audit and health authority inspections.
• Strive for a collaborative, innovative, and results-oriented analytical development culture.

Qualifications

• Minimum BS degree in analytical chemistry, organic chemistry or related disciplines. Advanced degrees (e.g. MS, PhD) are preferred.
• 5+ years of relevant industrial experience in analytical development and/or Quality Control.
• Demonstrated experience independently managing analytical development and quality control activities for small molecule oral solid dosage form products through external laboratories and manufacturing partners
• Strong experience in GMP change controls and OOS investigations.
• Experience managing projects at CROs/CDMOs.
• Working experience and knowledge of regulatory submission (IND, IMPD, and/or NDA).
• Effective written and verbal communication skills and interpersonal skills.
• Strong knowledge and understanding of current ICH guidelines, GMP guidelines, USP, EP, and related industry practices.
• Strong technical troubleshooting, problem-solving, and execution skills with the ability to make timely, data-driven decisions.
• Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.Ability to multi-task and thrive in a fast-paced innovative environment.

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Pay Range:

The expected salary range for this position based on the primary location of South San Francisco, CA is $181,620 - $211,890. The base pay offered will take into account internal equity and may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

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.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer