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Cmc In Biotech Jobs in California (NOW HIRING)

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable ... Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or ...

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Cmc In Biotech information

What is a CMC in biotech position?

A CMC (Chemistry, Manufacturing, and Controls) position in biotech involves overseeing the development, manufacturing, and quality control of biopharmaceutical products. Professionals in this role ensure that products meet regulatory standards and are produced consistently, often requiring knowledge of GMP regulations, process development, and analytical techniques.

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that manufacturing processes meet quality standards and regulatory requirements, often working with laboratory analysis, process validation, and compliance documentation.

What is the CMC department in biotech?

The CMC (Chemistry, Manufacturing, and Controls) department in biotech is responsible for developing, manufacturing, and ensuring the quality of biopharmaceutical products. It involves activities such as process development, validation, regulatory documentation, and quality control to ensure products meet safety and efficacy standards.
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Infographic showing various Cmc In Biotech job openings in California as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 12% Part Time, 3% Temporary, and 5% Contract. Highlights an 81% Physical, 5% Hybrid, and 14% Remote job distribution.

Senior Director, Regulatory CMC

Senti Biosciences

South San Francisco, CA • On-site

$245K - $285K/yr

Full-time

Posted 12 days ago

Job description

The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate will ensure that all CMC regulatory goals are clearly defined and they align with current industry standards and regulatory requirements. This role will also provide significant input on applicable regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This individual must be highly skilled and provide expertise in CMC agency interactions and developing regional regulatory CMC strategies. In addition, the position assists corporate senior management in understanding CMC Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Familiarity with GMP Quality, CMC development and  exposure to clinical regulatory strategy is highly desired. (***For the potential candidate at VP level direct report possibilities)

Responsibilities
  • Develop the CMC regulatory strategies and manage related regulatory activities. Work with the Pharmaceutical Development team to prepare project plans and timelines for pipeline of products, including coordination and oversight of all types of regulatory CMC submissions including type B, C, D meetings.
  • Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc. Prep and author updates in conjunctions with the cross-functional teams.
  • Advise the global regulatory phase-appropriate compliance of gene and cell therapy pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation.
  • Lead the preparation, authoring, review and filing of CMC sections of regulatory submissions with the highest quality and robust interactions with regulatory agencies.
  • Maintain a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations. Create and issue status reports and other communication to the organization.
  • Provide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs primary point of contact to cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, contract organizations and consultants. Ensure that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.
  • Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.
  • Ensure the regulatory conformance of technical documentation including technical transfer protocols, validation protocols, technical reports, manufacturing and labeling information.
  • Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the impact of new and changing regulations/requirements.
  • Author, review, and maintain regulatory and scientific documents to support business and submission needs.
  • Track and report on Medical Writing and Regulatory Operations projects, timelines, and key milestones to support timely execution.
Qualifications
  • BA/BS in a scientific field of study with 10 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry.
  • Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biologics drug development.
  • Experience in the gene or cell therapy area is preferred.
  • Proven ability to analyze and organize information logically.
  • In depth understanding and application of industry standards and international regulations and guidelines.
  • Experience in communicating regulatory strategy, submission documents and plans both internally and externally.
  • The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment.
  • Strong collaboration, team work, organizational skills at attention to detail
  • Excellent written and verbal communication skills.
  • Travel 20%
Salary and Benefits
  • Compensation for this role includes base salary, annual target bonus and equity
  • The base salary range for this role is $245,000-285,000. Starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity
  • Significant growth opportunity as the company expands
  • Empathetic, supportive and collaborative colleagues and work environments
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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