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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 ...

Neurocrine Biosciences

Director, Regulatory CMC

San Diego, CA · On-site

$159K - $210K/yr

Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure ... in the Pharmaceutical/Biotech industry. Prior project regulatory leadership experience with ...

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Cmc In Biotech information

What is the highest paying job in the biotech industry?

In the biotech industry, senior roles such as Vice President of Research and Development or Chief Scientific Officer typically have the highest salaries, often exceeding several hundred thousand dollars annually. These positions require extensive experience, advanced degrees, and leadership skills, and they oversee strategic research initiatives and regulatory compliance.

How is CMC used in pharmaceuticals?

In the context of CMC (Chemistry, Manufacturing, and Controls) in biotech jobs, CMC involves developing and controlling the processes for drug production, ensuring quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, which are essential for regulatory approval and manufacturing consistency.

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 drugs are manufactured consistently, meet quality standards, and comply with regulatory requirements, often working with laboratory techniques, quality assurance, and regulatory submissions.

What is the difference between CMC and GMP?

In biotech, CMC (Chemistry, Manufacturing, and Controls) refers to the documentation and processes ensuring a drug's quality, safety, and efficacy, while GMP (Good Manufacturing Practice) is a set of regulations that govern how drugs are produced to meet quality standards. CMC involves developing and controlling the product, whereas GMP ensures the manufacturing environment and procedures comply with quality requirements. Both are essential for regulatory approval and quality assurance in biotech roles like CMC specialists.
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Cmc In Biotech jobs near you
Infographic showing various Cmc In Biotech job openings in California as of June 2026, with employment types broken down into 78% Part Time, and 22% Contract. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution.

Corporate Compliance Officer

Trova Talent Consulting

San Diego, CA • On-site

Full-time

Posted 24 days ago

Job description

Summary
The Corporate Compliance Officer is responsible for leading, developing, and overseeing the company's comprehensive corporate compliance program, with a primary focus on internal compliance, trade compliance, reporting requirements, document retention, quality compliance, anti-corruption, data privacy and industry standards in the pharmaceutical/biotech sector. Reporting to the Executive Vice President-General Counsel, this role partners closely with Commercial, Clinical, CMC, Quality, Regulatory, and Operations to ensure all company activities align with applicable laws, regulations, contractual obligations, and ethical standards. The ideal candidate is a seasoned compliance professional with deep pharmaceutical or biotech experience, proven leadership in building and managing compliance programs, with experience in international trade compliance involving Europe and/or Japan (e.g., export controls, sanctions, trade regulations, customs, or cross-border technology transfer).
Responsibilities
Compliance Program Leadership & Governance
  • Design, implement, maintain, and continuously improve corporate compliance program, including policies, procedures, risk assessments, monitoring, and auditing frameworks.
  • Assist in the development, implementation, and updating of corporate policies, SOPs, and legal processes.
  • Lead the development and delivery of compliance training and communications across the organization.
  • Oversee compliance monitoring, internal investigations, corrective actions, and reporting to senior leadership and the Board as needed.
  • Maintain and enhance compliance tools, playbooks, dashboards, and processes to support scalability.
Commercialization Readiness
  • Provide strategic compliance guidance on commercialization planning, including distribution, supply chain, marketing, field operations, patient support programs, and HCP/payer engagements.
  • Ensure promotional materials, scientific exchange, pre-approval communications, medical affairs activities, and vendor interactions comply with FDA, EMA, Sunshine Act, Anti-Kickback Statute, False Claims Act, and other relevant laws.
  • Review commercial, medical, and vendor-related materials and activities for regulatory and compliance risk.
International Trade Compliance (Europe and/or Japan)
  • Oversee compliance with U.S. and foreign export controls, sanctions regimes (OFAC, EU, Japan), customs regulations, and trade agreements relevant to operations and partnerships in Europe and/or Japan.
  • Manage classification, licensing, and documentation for cross-border transfers of technology, biological materials, data, and equipment.
  • Conduct due diligence and risk assessments for international transactions, partnerships, and clinical/commercial activities in these regions.
Third-Party & Vendor Compliance Oversight
  • Lead third-party risk management, including anti-corruption due diligence (FCPA/UK Bribery Act/Japanese regulations), screening, contracting requirements, and ongoing monitoring.
  • Collaborate with Procurement, CMC, Manufacturing, Quality, and International teams to ensure third-party obligations meet compliance and operational standards.
  • Address vendor compliance issues, disputes, and audit findings.
Corporate, Operational & Risk Support
  • Partner on data privacy (GDPR, CCPA, etc.), confidentiality, information governance, and cybersecurity compliance initiatives.
  • Support audit readiness, regulatory inspections, and third-party assessments.
  • Advise on emerging regulatory and compliance trends in the pharma/biotech industry and communicate implications to stakeholders.

Requirements
  • Bachelor's degree required; J.D. preferred.
  • 10+ years of progressive compliance experience in the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role overseeing compliance programs.
  • Demonstrated experience managing international trade compliance matters involving Europe and/or Japan (export controls, sanctions, customs, technology transfer, or equivalent).
  • Deep knowledge of compliance laws and industry codes.
  • Experience supporting commercialization and launch-stage activities in biotech/pharma strongly preferred.
  • Proven ability to build and lead compliance functions in dynamic, fast-paced environments.
  • Strong risk assessment, investigation, and issue-management skills.
  • Excellent communication, influence, and cross-functional collaboration abilities.

Apply