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Cmc Consulting 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 ...

Socket.dev

NY · On-site

$87 - $294/hr

Minimum of 5 years of experience in either consulting or industry in life sciences supply chain and manufacturing space in digital CMC and PLM * Bachelor's degree or equivalent (minimum 12 years ...

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 ...

Syner-G

Vice President, Biologics

Seattle, WA · Remote

Lead and personally execute biologics CMC consulting engagements, serving as the primary technical point of contact across program lifecycle * Provide expert guidance across biologics development ...

taiho

Director, Regulatory Affairs CMC

Princeton, NJ · Hybrid

$157K - $207K/yr

Directs and coordinate regulatory activities of external consultants in consultation with Global ... Fifteen years' previous CMC drug development and regulatory experience (both US and EU\ preferably ...

Taiho Oncology

$166K - $220K/yr

Directs and coordinate regulatory activities of external consultants in consultation with Global ... Fifteen years' previous CMC drug development and regulatory experience (both US and EU\ preferably ...

ZS

Computational Modeling Consultant - CMC

Chicago, IL · On-site

$160K - $177K/yr

As a management consulting and technology firm focused on improving life and how we live it, we ... Partner with pharmaceutical CMC clients to identify high-value opportunities for computational ...

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How much do cmc consulting jobs pay per hour?

As of Aug 28, 2026, the average hourly pay for cmc consulting in the United States is $38.80, according to ZipRecruiter salary data. Most workers in this role earn between $19.71 and $58.41 per hour, depending on experience, location, and employer.

What is a CMC consulting?

A CMC (Chemistry, Manufacturing, and Controls) Consulting job involves providing expert guidance on pharmaceutical product development, regulatory compliance, and manufacturing processes. Consultants help companies navigate FDA and global regulatory requirements, optimize production strategies, and ensure the quality and stability of drug products. They may work on tasks such as preparing regulatory submissions, troubleshooting manufacturing issues, and advising on best practices for formulation and process development.

What are the typical responsibilities of a CMC consultant?

As a CMC Consultant, your daily responsibilities often involve preparing and reviewing regulatory documentation, assessing manufacturing processes for compliance, and providing strategic guidance to clients on CMC-related challenges. You’ll work closely with multidisciplinary teams, including R&D, quality assurance, and regulatory affairs, to ensure all aspects of product development and manufacturing meet global regulatory standards. Problem-solving and clear client communication are key, as you may also participate in client meetings and presentations. This dynamic role offers the opportunity to influence critical milestones in drug development and collaborate with a variety of stakeholders.

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

Excelling in CMC (Chemistry, Manufacturing, and Controls) Consulting requires a robust background in pharmaceutical sciences, regulatory affairs, and process development, typically backed by an advanced degree in a related field. Familiarity with key regulatory submission systems (such as eCTD), knowledge of ICH guidelines, and experience with quality management tools and software are highly valuable. Strong project management, problem-solving abilities, and effective communication skills help consultants navigate complex client needs and cross-functional teams. These competencies are critical for ensuring regulatory compliance, timely project delivery, and high-quality outcomes for clients in the life sciences sector.

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Cmc Consulting jobs near you
Infographic showing various Cmc Consulting job openings in the United States as of August 2026, with employment types broken down into 83% Full Time, 12% Part Time, and 5% Contract. Highlights an 83% Physical, 5% Hybrid, and 12% Remote job distribution, with an average salary of $80,700 per year, or $38.8 per hour.

CMC Consultant

Remote

Atomic
See more jobs at Atomicexternal

Contractor

Re-posted 7 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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