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Cmc Consultant Jobs (NOW HIRING)

Allucent

Director, CMC

Cary, NC · On-site +1

Minimum 9 years as a CMC strategy consultant as an independent contractor/consultant or as an employee at a CRO * Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and ...

Allucent

Director, CMC

Cary, NC · Remote

Minimum 9 years as a CMC strategy consultant as an independent contractor/consultant or as an employee at a CRO * Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and ...

Allucent

Director, CMC

Cary, NC · Remote

Minimum 9 years as a CMC strategy consultant as an independent contractor/consultant or as an employee at a CRO * Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Represent CSL in official regulatory CMC capacities, acting as an authorized official or ... Provide regulatory consultation to internal CSL functions, including Global Operation functions ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$300 - $380/hr

There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...

BrainChild Bio

Director, Regulatory Affairs, CMC

$153K - $202K/yr

... expert consultants, and global health authorities. Responsibilities: * Lead all operational and ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...

Immunedge Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...

BrainChild Bio

Director, Regulatory Affairs, CMC

Charleston, WV · Remote

$153K - $202K/yr

... expert consultants, and global health authorities. Responsibilities: * Lead all operational and ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Represent CSL in official regulatory CMC capacities, acting as an authorized official or ... Provide regulatory consultation to internal CSL functions, including Global Operation functions ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Represent CSL in official regulatory CMC capacities, acting as an authorized official or ... Provide regulatory consultation to internal CSL functions, including Global Operation functions ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Represent CSL in official regulatory CMC capacities, acting as an authorized official or ... Provide regulatory consultation to internal CSL functions, including Global Operation functions ...

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Cmc Consultant information

See salary details

$10

$38

$82

How much do cmc consultant jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for cmc consultant in the United States is $38.02, according to ZipRecruiter salary data. Most workers in this role earn between $20.67 and $48.08 per hour, depending on experience, location, and employer.

What is a CMC consultant?

CMC consultants are professionals who specialize in Chemistry, Manufacturing, and Controls (CMC) within the pharmaceutical, biotechnology, and related industries. Their primary role is to provide expert guidance on the development, manufacturing, and regulatory submission of drug products, ensuring compliance with international standards. They assist companies in preparing CMC documentation for regulatory agencies, troubleshooting manufacturing issues, and optimizing processes for quality and efficiency. CMC consultants often work on projects involving drug formulation, process validation, analytical method development, and quality control. Their expertise is crucial for bringing safe and effective therapies to market.

What are the key skills and qualifications needed to thrive as a CMC consultant?

To thrive as a CMC Consultant, you need a deep understanding of Chemistry, Manufacturing, and Controls (CMC) regulations, pharmaceutical development, and quality assurance, often supported by an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, GMP compliance tools, and relevant documentation software is typically required. Strong project management, analytical thinking, and effective communication skills help you collaborate with cross-functional teams and interpret complex regulatory requirements. These skills ensure successful regulatory submissions, product quality, and compliance throughout the drug development lifecycle.

How does a CMC consultant typically interact with cross-functional teams during a project?

As a CMC (Chemistry, Manufacturing, and Controls) Consultant, you'll frequently collaborate with cross-functional teams such as regulatory affairs, quality assurance, and product development. Your role involves translating technical manufacturing and analytical requirements into documentation that meets regulatory standards, while also ensuring alignment with project timelines and goals. Regular meetings, written reports, and collaborative problem-solving are integral parts of daily responsibilities, helping to ensure seamless communication and efficient progress toward regulatory submissions and product launches.

What is the difference between Cmc Consultant vs Regulatory Affairs Specialist?

AspectCmc ConsultantRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, often with certifications in CMC or related fieldsBachelor's degree in life sciences, with certifications in regulatory affairs or compliance
Work EnvironmentConsulting firms, pharmaceutical or biotech companies, project-based rolesIn-house regulatory departments, pharmaceutical companies, government agencies
Industry UsageCommonly hired for CMC-related projects, product development, and compliance consultingResponsible for ensuring regulatory compliance, submissions, and communication with authorities

The main difference between a Cmc Consultant and a Regulatory Affairs Specialist lies in their focus and work setting. Cmc Consultants typically work on product development and compliance projects within consulting firms or client companies, while Regulatory Affairs Specialists handle ongoing regulatory submissions and compliance within organizations. Both roles require similar educational backgrounds but differ in scope and daily responsibilities.

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Cmc Consultant jobs near you
Infographic showing various Cmc Consultant job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 89% Full Time, 6% Part Time, and 4% Contract. Highlights an 71% Physical, 3% Hybrid, and 26% Remote job distribution, with an average salary of $79,074 per year, or $38 per hour.

Director, CMC

Allucent

Cary, NC • On-site, Remote

Full-time

Re-posted 18 days ago

Job description

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Sr. Director, CMC to join our A-team (hybrid*/remote) in the USA. As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products
About the role
As the Sr. Director, CMC, you will:
  • Lead end-to-end CMC strategy across drug substance, drug product, and analytical development-from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
  • Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
  • Prepare product development plans from early development through Phase 4.
  • Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
  • Perform other related duties, as needed.

Requirements
  • Minimum 9 years as a CMC strategy consultant as an independent contractor/consultant or as an employee at a CRO
  • Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
  • Advanced scientific and regulatory knowledge of drug, biologic, or device development
  • Experience in pre-approval products; large biologics experience required.
  • Line management experience required.
  • Prior CRO experience preferred.

Skills:
  • Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, strong written and verbal communication skills in English
  • Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
  • Quality focus
  • Strong emotional intelligence, customer focused leadership and decision-making skills
  • Innovative, creative, and practical thinking including problem-solving skills
  • >10 years' post-degree of directly relevant experience in drug, biologic, or device development desirable

Benefits
Benefits of working at Allucent include:
  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program '

Disclaimers:
*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.
"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."
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