New · posted Nov 1
Cytokinetics · Pharmaceuticals
Senior Manager, CMC Quality Control
- South San Francisco, CA
- On-site
- Full-time
- Manager
The role
The Senior Manager, CMC Quality Control, 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.
Cytokinetics is 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.
What you need
- 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.
What you'll do
- 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.
Pay and benefits
$181,620 – $211,890 a year
Employer providedThe 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.
Equity (stock options/RSUs)
Health, dental and vision insurance
Life and disability insurance
401k with employer match
Learning and wellness stipends
Paid time off
Where you'll work
South San Francisco, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAEqual opportunity, accessibility and legal noticesCytokinetics's statements, word for word
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 [email protected]
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 74% above the US median for Quality Control roles at this level.
This roleEmployer provided
Manager roles in California9 roles publishing pay
Manager roles in the US31 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $181,620 | — | $211,890 |
| California (middle half) | $102,500 | $128,500 | $140,000 |
| All US (middle half) | $103,000 | $113,000 | $131,500 |
This role: Cytokinetics's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 353 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Cytokinetics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods19
- GMP and compliance8
- Collaboration and leadership7
- Documentation and SOPs6
- Validation and qualification4
- Regulatory submissions4
- Quality systems and risk4
- Clinical trial conduct4
- Investigations and CAPA2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Cytokinetics on Regulatory Jobs
- 16
- Open roles
- 15
- Distinct roles
- 2
- Locations
By discipline
- Regulatory7 44%
- Quality5 31%
- Clinical4 25%
By level
- Director7 44%
- Manager7 44%
- Senior & Principal2 13%
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Senior Manager, CMC Quality Control at Cytokinetics
Open until filled. $182K–$212K a year, employer provided.