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Cmc Contract Jobs (NOW HIRING)

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Director/ Senior Director, Regulatory CMC

Boston, MA · On-site

$163K - $215K/yr

... managing contract staff and vendors relevant to CMC activities. • Build and maintain strong relationships with internal and external stakeholders. Skills and requirements: • PharmD or PhD ...

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Cmc Contract information

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$17

$26

$49

How much do cmc contract jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for cmc contract in the United States is $26.18, according to ZipRecruiter salary data. Most workers in this role earn between $20.19 and $28.61 per hour, depending on experience, location, and employer.

What is the difference between Cmc Contract vs Cmc Coordinator?

AspectCmc ContractCmc Coordinator
Required CredentialsTypically requires a degree in life sciences or related field, with experience in contract managementUsually requires a degree in life sciences, with some experience in project coordination or administration
Work EnvironmentWorks primarily in legal, regulatory, or contract management departments within biotech or pharma companiesWorks in project teams, supporting CMC activities in pharmaceutical or biotech settings
Employer & Industry UsageCommonly employed in pharmaceutical, biotech, and contract research organizationsFound in similar industries, often supporting CMC teams in drug development

The main difference is that a Cmc Contract focuses on managing and negotiating contracts related to CMC activities, while a Cmc Coordinator handles the coordination and administrative support within CMC projects. Both roles require familiarity with CMC processes, but their responsibilities and focus areas differ.

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Cmc Contract jobs near you
Infographic showing various Cmc Contract job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 18% Part Time, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $54,445 per year, or $26.2 per hour.

Manager, CMC Drug Substance

Albert B Sabin Vaccine Institute, Inc.

Remote

$109K - $130K/yr

Full-time

Posted 13 days ago

Job description

Reports to: Senior Manager, CMC
Location: Remote work, US Only
Why Sabin:
Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership, and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.
Position Summary:
The Manager, CMC Drug Substance provides technical leadership and expertise across Chemistry, Manufacturing, and Controls (CMC) activities supporting vaccine drug substance development. This role focuses on process development, characterization, technology transfer, and GMP manufacturing, supporting programs from late-stage clinical development through process validation, regulatory licensure, and commercialization.
The successful candidate will possess demonstrated experience leading technology transfers across process development and manufacturing environments, with hands-on knowledge of vaccine manufacturing operations and viral vaccine platforms, including adenovirus-vectored vaccines or comparable systems. The individual will provide technical leadership for drug substance development and manufacturing activities, partnering closely with internal teams, contract development and manufacturing organizations (CDMOs), and external stakeholders to support process scale-up, validation, regulatory compliance, and commercial readiness. Success in this role requires strong cross-functional collaboration, sound scientific judgment, and a commitment to advancing vaccine access and global health impact.
Working closely with internal teams, contract development and manufacturing organizations (CDMOs), and external stakeholders, the Manager will drive project execution by coordinating technical activities, managing risks, and ensuring alignment with program objectives, timelines, and regulatory requirements. The role requires strong scientific and technical expertise, sound judgment, and the ability to work effectively across cross-functional teams.
The Manager, CMC Drug Substance will collaborate across CMC, clinical, regulatory, quality, and global health functions to advance vaccine programs through critical development milestones. The ideal candidate combines technical leadership, intellectual curiosity, and a commitment to expanding equitable access to vaccines and improving global health outcomes.
Key Responsibilities:
  • Support the planning, coordination, and execution of vaccine development programs from late-stage clinical development through regulatory submission and commercial supply, partnering with cross-functional scientific, analytical, regulatory, manufacturing, and global health stakeholders to achieve key milestones and timelines
  • Support site selection and onboarding of a new Drug Substance Site
  • Lead the tech transfer of a Phase 3 vaccine manufacturing process to external Drug Substance manufacturing partners, ensuring successful process scale-up, validation, and commercial readiness
  • Execute technology transfer strategies, project plans, governance structures, and risk mitigation plans to ensure successful transfer and lifecycle management of manufacturing processes
  • Lead process characterization, comparability assessments, scale-up/scale-down studies, and process validation activities to establish robust manufacturing processes and support regulatory submissions. Develop and maintain the Drug Substance process control strategy, including process parameter criticality assessments, critical process parameter (CPP) identification, critical in-process controls (cIPCs), and contribute to continued process verification (CPV) strategies
  • Author, review, and approve CMC technical documentation, including technology transfer packages, process characterization reports, validation documentation, regulatory submission content, comparability reports, and responses to Health Authority inquiries.
  • Drive project execution by managing technical deliverables, timelines, risks, and cross-functional dependencies, ensuring alignment with organizational priorities, regulatory requirements, and donor commitments.
  • Ensure compliance with cGMP, regulatory expectations, quality standards, and organizational procedures throughout process development, technology transfer, validation, and commercial manufacturing
  • Contribute to funding proposals, grant reporting, and strategic planning efforts to advance vaccine access and equity worldwide

Requirements
  • Bachelor's degree in biochemistry, chemistry, biology, chemical engineering or related pharmaceutical science
  • Minimum of 7+ years of experience in biopharmaceutical CMC, manufacturing, process development, and technology transfer
  • Demonstrated experience in biopharmaceutical manufacturing, MS&T, and/or process development environments, including hands-on experience with mammalian or viral cell culture, upstream and downstream processing, and purification operations (e.g., chromatography, filtration/ultrafiltration, viral clearance)
  • Prior technology transfer experience, including leading or supporting site-to-site, scale-up, or CDMO transfers
  • Experience with adenovirus-vectored vaccines or other viral vector platforms (e.g., AAV, poxvirus, lentiviral vectors) is strongly preferred; candidates with comparable complex biologics manufacturing experience will also be considered
  • Strong analytical, problem-solving, organizational, communication, and interpersonal skills, with the ability to work effectively both independently and collaboratively across cross-functional teams, global stakeholders, and diverse audiences
  • Commitment to health equity and improving immunization access in underserved populations

Preferred Skills and Experience:
  • Direct experience operating in cGMP-regulated environments, including support for non-conformance investigations, root cause analysis, change control, and CAPA implementation
  • Working knowledge of ICH guidelines and global regulatory requirements (e.g., FDA, EMA, MHRA), with experience supporting late-stage development programs, regulatory submissions (e.g., BLA/NDA), and commercial supply activities
  • Experience working with external manufacturing partners

Other:
  • Subject to a criminal background investigation
  • Request for three professional references
  • Verification of education/degrees
  • Travel up to 25%

Salary Description
$109,000 - $130,000

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