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Formulation Development Cmc Jobs in California (NOW HIRING)

Nurix

Director, Pharmaceutical Development

Brisbane, CA · On-site

Formulation & Process Development * Lead QbD-based formulation and process development for small ... Author and review CMC sections of regulatory submissions including INDs, NDAs, and MAAs. * Ensure ...

Nurix

Director, Pharmaceutical Development

Brisbane, CA · On-site

Formulation & Process Development * Lead QbD-based formulation and process development for small ... Author and review CMC sections of regulatory submissions including INDs, NDAs, and MAAs. * Ensure ...

Codera LLC

Director, CMC - Formulations

San Diego, CA · On-site

$190K - $260K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Research CMC and formulation topics to support Tang Capital's investments * Participate in business development activities, as requested Qualifications * Bachelor's degree or higher in life sciences ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$300 - $380/hr

Scope covers CMC strategy, cell line and process development, analytical development and characterization, formulation, external manufacturing and supply, and the CMC sections of regulatory ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Scope covers CMC strategy, cell line and process development, analytical development and characterization, formulation, external manufacturing and supply, and the CMC sections of regulatory ...

Immunedge Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Scope covers CMC strategy, cell line and process development, analytical development and characterization, formulation, external manufacturing and supply, and the CMC sections of regulatory ...

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Formulation Development Cmc information

What is formulation development CMC?

Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition of a drug product, ensuring it is safe, effective, and stable for patient use. This role involves selecting appropriate excipients, developing the manufacturing process, and generating the data required to support regulatory submissions. CMC professionals collaborate with research, quality, and regulatory teams to ensure that the drug product meets all necessary standards throughout its lifecycle.

What are the key skills and qualifications needed to thrive as a formulation development CMC specialist?

To thrive as a Formulation Development CMC specialist, you need expertise in pharmaceutical sciences, chemistry, and regulatory guidelines, often supported by an advanced degree in a relevant field. Familiarity with analytical techniques, formulation equipment, and regulatory submission systems like eCTD is crucial. Strong problem-solving skills, attention to detail, and effective collaboration are essential soft skills in this role. These competencies ensure the successful development, optimization, and regulatory approval of safe and effective pharmaceutical products.

What are some typical challenges faced by professionals in formulation development CMC, and how are they addressed?

Professionals in Formulation Development CMC often encounter challenges such as ensuring formulation stability, meeting regulatory requirements, and scaling up from laboratory to manufacturing. Addressing these challenges requires close collaboration with analytical, regulatory, and manufacturing teams, as well as staying current with evolving guidelines. Effective project management, rigorous experimental design, and proactive risk assessment are key strategies to successfully navigate these complexities and ensure timely progress of drug development projects.

What is the difference between Formulation Development Cmc vs Formulation Scientist?

AspectFormulation Development CmcFormulation Scientist
CredentialsBachelor's or Master's in Pharmacy, Chemistry, or related fields; industry certificationsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields
Work EnvironmentPharmaceutical or biotech R&D labs, manufacturing settingsResearch labs, development facilities, pharmaceutical companies
Industry UsageRegulatory submissions, product development, manufacturing supportFormulation research, experimental design, product optimization

Formulation Development Cmc focuses on developing formulations suitable for regulatory approval and manufacturing, often involving documentation and compliance. Formulation Scientists primarily conduct research and experiments to create and optimize formulations. While both roles require similar educational backgrounds and work in related environments, Cmc roles emphasize regulatory and manufacturing aspects, whereas Scientists focus on experimental research and innovation.

What are popular job titles related to Formulation Development Cmc jobs in California?

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

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

The top searched job categories for Formulation Development Cmc jobs in California are:

What cities in California are hiring for Formulation Development Cmc jobs?

Cities in California with the most Formulation Development Cmc job openings:

Formulation Development Cmc jobs near you
Infographic showing various Formulation Development Cmc job openings in California as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 11% Part Time, and 2% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution.

Scientist II, Drug Product

Revolution Medicines

Redwood City, CA • Hybrid

Full-time

Re-posted 24 days ago

Job description

The Opportunity:

Revolution Medicines is seeking Scientist II to join the Drug Product team within Pharmaceutical Development & Manufacturing (PDM). This role will support the development of solid oral dosage forms for small molecule programs across the RVMD pipeline.

The successful candidate will contribute to formulation and process development activities from early-stage through late-stage clinical/commercial development, working closely with cross-functional partners and CDMOs to ensure robust, scalable, and compliant drug product manufacturing processes.

Key Responsibilities:

  • Contribute to drug product development activities for new chemical entities (NCEs) from early development through late-stage clinical development, with exposure to commercialization activities.

  • Design and execute drug product development and manufacturing activities for solid oral dosage forms, including:

    • Preformulation and formulation development.

    • Manufacturing process development.

    • Process scale-up, technology transfer, and process optimization.

    • Process validation and commercial manufacturing support.

  • Support outsourced development and GMP drug product manufacturing activities at CDMOs including manufacturing oversight and troubleshooting.

  • Design and execute experiments, analyze and interpret data and present results and conclusions to project teams.

  • Work independently with limited supervision to conduct appropriate research and troubleshoot technical challenges, escalating complex issues as needed.

  • Author and contribute to CMC documentation for regulatory submissions (e.g., INDs, NDAs, MAAs) and internal technical reports.

  • Collaborate cross-functionally within CMC team (Clinical Supply, Analytical Development/QC, Quality Assurance, Drug Substance, Regulatory Affairs, and Project Management) and at enterprise level research/clinical/commercial teams to support aligned development strategy and execution.

  • Travel up to 20% to CRO/CDMO sites to support and oversee development and manufacturing operations.

Required Skills, Experience and Education:

  • A degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

  • Ph.D. with minimum of 3+ years of experience or a bachelor's/master's degree with appropriate experience in the pharmaceutical/biotech industry settings.

  • Experience supporting drug product development and manufacturing for small molecules.

  • Demonstrated experience in solid oral dosage formulation and process development for small molecules.

  • Experience working with external partners (CDMOs/CROs) and overseeing outsourced development and manufacturing activities.

  • Working knowledge of global regulatory expectations, including ICH guidelines and FDA, EMA, PMDA etc. requirements.

  • Experience contributing to CMC regulatory filings is desirable.

  • Strong technical writing, communication, and problem-solving skills.

  • Ability to manage multiple priorities and thrive in a fast-paced, innovation-driven collaborative environment.

Preferred Skills:

  • Ph.D. degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable. 

    #LI-Hybrid #LI-CT1

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