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Cmc Operations Jobs in California (NOW HIRING)

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

End-to-End Product Development & Technical Operations: Lead the integrated CMC strategy from developability and candidate selection through cell line development, upstream and downstream process ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

End-to-End Product Development & Technical Operations: Lead the integrated CMC strategy from developability and candidate selection through cell line development, upstream and downstream process ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the ...

Immunedge Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

End-to-End Product Development & Technical Operations: Lead the integrated CMC strategy from developability and candidate selection through cell line development, upstream and downstream process ...

AbbVie

Associate Director, RA CMC

Irvine, CA · On-site

$141K/yr

Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development ...

AbbVie

Associate Director, RA CMC

Irvine, CA · On-site

Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development ...

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Showing results 21-40

All JobsCmc Operations JobsCmc Operations Jobs in California

Cmc Operations information

What is the difference between Cmc Operations vs CMC Regulatory Affairs?

AspectCmc OperationsCMC Regulatory Affairs
Required CredentialsBachelor's degree in life sciences, engineering, or related field; experience in manufacturing or quality controlDegree in life sciences, pharmacy, or related; regulatory certifications often preferred
Work EnvironmentManufacturing plants, quality control labs, supply chainRegulatory agencies, corporate offices, compliance teams
Industry UsageManufacturing, quality assurance, supply chain managementRegulatory submissions, compliance, documentation
Common Search/ComparisonYesYes

While both Cmc Operations and CMC Regulatory Affairs are essential in the pharmaceutical industry, Cmc Operations focuses on manufacturing, quality control, and supply chain processes. In contrast, CMC Regulatory Affairs handles regulatory submissions, compliance, and documentation to ensure products meet legal standards. Understanding these differences helps professionals and employers align roles with their expertise and industry needs.

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For Cmc Operations jobs in California, the most frequently searched job titles are:

What job categories do people searching Cmc Operations jobs in California look for?

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Cmc Operations jobs near you
Infographic showing various Cmc Operations job openings in California as of September 2026, with employment types broken down into 1% As Needed, 77% Full Time, 18% Part Time, 1% Temporary, 2% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Associate Director, Technical Operations (Small Molecule CMC)

San Diego, CA • On-site

Travere Therapeutics
Biotechnology Research and Development • 51 - 200 employees
Learn more about Travere Therapeuticsexternal

Full-time

Medical, Life, Retirement, PTO

Re-posted 16 days ago

Job description

Department:
106800 Technical Operations
Location:
San Diego, USA- Remote
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
Position Summary:
The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs. This role is a critical contributor within Technical Operations (CMC) and broadly supports the product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management of small molecule drug products.
This individual will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and successful achievement of program milestones. The successful candidate will bring substantial experience in small molecule API development and manufacturing, appropriate for advancing a late-stage development asset to commercial readiness.
Responsibilities:
  • Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at Travere CDMOs.
  • Review and approve manufacturing-related documentation, including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
  • Verify suitability, qualification, and validation status of processes at CDMOs and other external laboratories.
  • Provide technical support for GMP quality management systems, including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
  • Collaborate with internal and external project teams to support CMC development, clinical supply, commercialization, and lifecycle management of small molecule drug products.
  • Author and review technical documents and regulatory submission content, including INDs, IMPDs, and NDAs.
  • Maintain up-to-date knowledge of US and EU GMP requirements, ICH guidelines, and other regulatory expectations applicable to pharmaceutical development and manufacturing.
  • Review project scope, timelines, and deliverables to ensure CDMO activities meet contractual obligations, quality standards, and program objectives.
  • Additional duties assigned as needed.

Education/Experience Requirements:
  • B.S. degree in chemistry, biochemistry, pharmaceutical science, chemical engineering, or related Life Sciences discipline required. M.S. or Ph.D degree preferred. Equivalent combination of education and applicable job experience may be considered.
  • 8+ years of relevant experience required with emphasis on late-phase clinical development, scale-up, and commercialization.
  • Expert knowledge in process development, characterization studies, PPQ, and commercialization of small molecule APIs for solid oral dosage formulations.
  • Demonstrated experience managing and providing technical oversight of CDMOs and contract testing labs, preferably across global manufacturing and testing sites.
  • Broad knowledge and experience with phase-appropriate cGMP requirements and applicable US, EU, and ICH guidelines.
  • Demonstrated ability to prepare and review CMC sections of regulatory filings, including INDs, IMPDs, and NDAs.

Additional Skills/Experience:
  • The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork
  • Driven, intelligent, passionate about making a difference for patients with rare diseases.
  • Strong professional experience in a similar role within the pharmaceutical industry, preferably in small molecule development and manufacturing for solid oral dosage forms.
  • Successful record of creating and managing complex project plans, timelines, budgets, and development of risk mitigation strategies.
  • Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
  • Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.
  • Excellent decision-making and collaboration skills with strong attention to detail.
  • Six Sigma and statistical knowledge is a plus.
  • Ability to travel 10-20% domestically and internationally.
  • All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Travere is an EEO/AA/Veteran/Disability Employer
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$150,000.00 - $195,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.

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