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Cmc Management Jobs (NOW HIRING)

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ... Strong project management and organizational skills. * Ability to manage multiple programs and ...

Intuitive

Project Manager, CMC

Sunnyvale, CA · On-site

Reporting to the Program Management & Operations organization, the CMC Project Manager partners with CMC, Manufacturing, Analytical Development, Quality, Regulatory Affairs, Supply Chain, Clinical ...

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$118.8K

$157.5K

How much do cmc management jobs pay per year?

As of Sep 13, 2026, the average yearly pay for cmc management in the United States is $118,816.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $132,000.00 per year, depending on experience, location, and employer.

What is CMC management?

CMC management refers to the oversight and coordination of Chemistry, Manufacturing, and Controls (CMC) processes in the development and production of pharmaceuticals or biologics. This includes ensuring the quality, safety, and consistency of drugs by managing formulation, manufacturing protocols, analytical testing, and regulatory documentation. Effective CMC management is critical for meeting regulatory requirements and ensuring that products are safe and effective for patients. Professionals in this field work closely with research, development, quality assurance, and regulatory teams to bring new therapies to market.

What are the key skills and qualifications needed to thrive in CMC management?

To succeed in CMC (Chemistry, Manufacturing, and Controls) Management, you need a deep understanding of pharmaceutical development, regulatory requirements, and process optimization, often supported by a degree in chemistry, pharmacy, or related fields. Familiarity with quality management systems, regulatory submission platforms, and industry standards like ICH guidelines is crucial. Strong leadership, project management, and cross-functional communication skills help drive complex projects and effective collaboration. These capabilities ensure products meet safety, efficacy, and compliance standards throughout the drug development lifecycle.

What are some common challenges faced by professionals in CMC management, and how can they be addressed?

Professionals in CMC (Chemistry, Manufacturing, and Controls) Management often encounter challenges such as navigating complex regulatory requirements across different markets, ensuring consistent product quality during scale-up, and managing cross-functional communication between R&D, manufacturing, and regulatory teams. Addressing these challenges involves staying updated with evolving regulations, fostering strong collaboration among teams, and implementing robust quality management systems. Clear documentation and proactive risk management are also essential to overcome hurdles and ensure smooth product development and approval processes.

What is the difference between Cmc Management vs Cmc Specialist?

AspectCmc ManagementCmc Specialist
CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; often requires experience in CMCSimilar educational background; may require specific certifications in regulatory affairs or quality assurance
Work EnvironmentOversees teams, manages projects, liaises with regulatory agenciesPerforms detailed review, documentation, and data analysis within the CMC process
Employer & Industry UsagePharmaceutical and biotech companies, regulatory agenciesPharmaceutical companies, contract research organizations, regulatory consulting firms

In summary, Cmc Management involves overseeing the entire CMC process, managing teams, and strategic planning, while Cmc Specialists focus on detailed technical work, data review, and documentation within the CMC scope. Both roles require relevant education and experience but differ in scope and responsibilities.

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Cmc Management jobs near you
Infographic showing various Cmc Management job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution, with an average salary of $118,816 per year, or $57.1 per hour.

Associate Director, CMC Program Mgmt

South San Francisco, CA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

$159K - $207K/yr

Other

Medical, Retirement

Posted 15 days ago

Job description

Key Accountabilities/Core Job Responsibilities:
  • Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research, pre-IND, and first-in-human through later phases, including pivotal Phase 2/3 and NDA/MAA/BLA submissions.
  • Manage CRO/CMO vendor selection; serve as point of contact for outsourced CMC projects and early-stage biotherapeutics requiring large-scale material production.
  • Facilitate, manage, and lead internal CMC project teams.
  • Establish and maintain CMC project timelines and budgets; track deliverables and ensure integration into overall project plans.
  • Proactively outline risks and mitigations; communicate risks/issues to CMC, project teams, and senior management.
  • Provide regular updates to senior management on status, timelines, risks, and future CMC needs.
  • Collaborate with technical leaders, Program Directors, and cross-functional teams to develop and execute drug development strategies and plans.
Qualifications/Skills:
  • BA/BS in Science/Math/Engineering or related field with 12+ years relevant biotech/pharma/CMO CMC experience (or Master’s with 10+ years).
  • Advanced degree and CMC experience with novel constructs (e.g., bi-specifics, enzyme fusions) preferred.
  • Experience managing CMC activities at CROs/CMOs required.
  • Drug Substance and Drug Product GMP experience required.
  • Command of project management practices and software.
  • Thorough understanding of the drug development process.
  • Excellent leadership/interpersonal skills; ability to build relationships with internal teams and CRO/CMO collaborators.
  • Strong conflict management; effective under high pressure.
  • Ownership mindset; results- and detail-oriented.
Compensation/Benefits:
  • Salary range: $159,000–$207,000.
  • Competitive total rewards package including 401k, healthcare coverage, and ESPP.
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