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Cmc Consultant Jobs (NOW HIRING)

Atomic

CMC Consultant

Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in ...

ZS

Decision Analytics Consultant- CMC

Manhattan, NY · On-site

$160K - $177K/yr

As a management consulting and technology firm focused on improving life and how we live it, we ... The primary responsibility of this role is to deliver projects in the pharmaceutical CMC ...

Accenture

Accenture is seeking a Consultant to drive project execution in Digital CMC and PLM transformation work within our Supply Chain & Engineering practice for Life Sciences. We work with our ...

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Cmc Consultant information

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$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.

CMC Consultant

Atomic

Remote

Contractor

Re-posted 27 days ago

Job description

About Us:
Indomo is a clinical stage therapeutics company transforming clinic-based procedures into at-home care via device-enabled therapeutics. Indomo's lead program couples a proven corticosteroid with an innovative intradermal self-injection device to create the first fast-acting at-home solution for inflammatory acne lesions.
Position Overview:
Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in advancing our lead asset through the NDA pathway by guiding CMC development, managing external partners, and ensuring regulatory readiness.
This role is ideal for a senior CMC expert who thrives in a hands-on, advisory + execution capacity and is comfortable working closely with a lean internal team and external CDMOs. The consultant will provide both strategic direction and tactical oversight across drug product development, analytical strategy, and integration with our device-enabled delivery system.
Key Responsibilities:
CMC Strategy
  • Help define and execute the overall CMC development strategy to support clinical progression and trial readiness
  • Support outsourced drug substance and drug product development with CDMO, including formulation optimization, stability, and device compatibility
  • Establish critical quality attributes, specifications, and acceptance criteria
  • Guide analytical method development, validation, and lifecycle management

External Vendor & Manufacturing Oversight
  • Interface with external stakeholders, including CDMOs, CROs, and suppliers.
  • Support selection, onboarding, and management of external partners.
  • Review deliverables, ensure timelines are met, and mitigate technical risks.
  • Advise on quality systems and inspection readiness.

Regulatory Support
  • Partner with regulatory team to shape CMC strategy for IND submission.
  • Organize execution of and contribute to regulatory documents (IND, briefing packages, NDA modules).
  • Prepare for and support FDA interactions (e.g., IND, EOP2, Type C meetings).

Qualifications:
Required
  • Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
  • 10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech/pharmaceutical settings.
  • Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance.
  • Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements.
  • Strong track record supporting INDs and/or NDAs.
  • Ability to operate independently in a fast-paced, dynamic startup environment.

Preferred
  • Experience with combination products (drug + delivery device).
  • Successful prior interactions with FDA on CMC topics.
  • Experience supporting programs from early clinical through late-stage development.

Why Join Indomo:
  • Opportunity to shape CMC strategy for an innovative combination product.
  • High-impact role with direct access to leadership and decision-making.
  • Collaborative, mission-driven team.
  • Flexibility in working style and scope.

We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
Atomic is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law.
Please review our CCPA policies here.

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