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Cmc Consulting Jobs (NOW HIRING)

Immatics NV

Senior CMC Program Manager

Houston, TX

$110K - $111K/yr

Experience coordinating external vendors, CMOs, CDMOs, or consulting partners * Strong ... Manage CMC deliverables, milestones, and critical paths while ensuring alignment with overarching ...

Immatics NV

Senior CMC Program Manager

Houston, TX · On-site

$110K - $111K/yr

Experience coordinating external vendors, CMOs, CDMOs, or consulting partners * Strong ... Manage CMC deliverables, milestones, and critical paths while ensuring alignment with overarching ...

CMC Phoenix

Pharmacist

Phoenix, AZ

$61 - $64/hr

College Medical Center Phoenix (CMC Phoenix) is seeking a full-time Pharmacist to join our team and ... Provide medication therapy consultations and support to healthcare staff and patients. * Document ...

CMC Phoenix

Overnight Pharmacist

Phoenix, AZ

$61 - $64/hr

College Medical Center Phoenix (CMC Phoenix) is seeking a full-time Pharmacist to join our team and ... Provide medication therapy consultations and support to healthcare staff and patients. * Document ...

UTMB Health

Staff Psychiatrist, CHS-CMC - CASUAL

Stafford, TX · On-site

$217K - $271K/yr

Works under the general direction of the UTMB - CMC, CHS medical director, with extensive latitude ... Regularly participates in clinical consultations with mental health and medical staff. * Conducts ...

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How much do cmc consulting jobs pay per hour?

As of Jun 22, 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 are some typical responsibilities of a CMC Consultant on a daily basis?

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 is a CMC Consulting job?

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 key skills and qualifications needed to thrive in the Cmc Consulting position, and why are they important?

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
Associate Director, Regulatory Affairs CMC

Associate Director, Regulatory Affairs CMC

Crispr Therapeutics

South Boston, MA • On-site

Full-time

Posted 6 days ago

Job description

Job Description:
Company Overview
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
This position is a key leadership role for the development of the Zugo-cel CAR-T franchise at CRISPR. Reporting to the Head of Regulatory Affairs, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strategies where little precedent exists. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.
Responsibilities
  • Act as Regulatory CMC Lead for assigned programs providing strategic guidance to development teams on complex Regulatory CMC topics.
  • In close collaboration with the CMC team, plan, prepare, and submit high-quality CMC related applications including INDs and CTAs globally.
  • Communicate with regulatory agencies on CMC topics, as appropriate.
  • Lead and support Health Authority meeting strategy and preparation for CMC topics.
  • Assess proposed technical changes and provide strategic regulatory guidance to enable global implementation.
  • Drive adherence to CMC regulatory guidelines relevant for the development of transformative gene-based medicines.
  • Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance and provide regulatory advice to program teams.
  • Build and maintain strong relationships with internal and external stakeholders.

Minimum Qualifications
  • Bachelor's degree required in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.
  • Prior regulatory CMC experience with a demonstrated track record of significant accomplishments:
    • Associate Director:
      • 12+ Years of relevant experience with a bachelor's degree
      • 10+ Years of relevant experience with an advanced degree
  • Must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics).
  • Current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these principles to Regulatory CMC strategies for novel products.
  • Working knowledge of eCTD requirements for submission to US and ex-US regulatory agencies for IND, IMPD, CTA, BLA, NDA, MAA.
  • Exceptional ability to communicate verbally and in writing, and superb organizational skills required.
  • Ability to manage multiple priorities within a dynamic organizational and team structure.

Preferred Qualifications
  • A PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.
  • Late phase IND/CTA/GMO submission authoring, and understanding of FDA/EMA requirements for corresponding dossier development

Competencies
  • Collaborative - Openness, One Team
  • Undaunted - Fearless, Can-do attitude
  • Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
  • Entrepreneurial Spirit - Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Associate Director, Regulatory Affairs CMC: Base pay range of $165,000 to $180,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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