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Head Of Cmc Jobs (NOW HIRING)

BeiGene, Inc.

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC. Essential Functions of the job: * Lead, develop, and continuously strengthen the U.S. Biologics Regulatory ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

This position reports to the Head of Regulatory Affairs. Essential Functions : * Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · Remote

$153K - $202K/yr

This position reports to the Head of Regulatory Affairs. Essential Functions : * Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ

$154K - $204K/yr

This position reports to the Head of Regulatory Affairs. Essential Functions : * Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial ...

Neion Bio

Head of Biologics Development & CMC

Manhattan, NY · On-site

$170K - $230K/yr

We are looking for an exceptional Head of Biologics Development & CMC to lead the development of therapeutic proteins produced using Neion Bio's egg-based biomanufacturing platform. This person will ...

Neion Bio

Head of Biologics Development & CMC

Manhattan, NY · On-site

$170K - $230K/yr

We are looking for an exceptional Head of Biologics Development & CMC to lead the development of therapeutic proteins produced using Neion Bio's egg-based biomanufacturing platform. This person will ...

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Head Of Cmc information

What are some typical challenges the Head of CMC faces when overseeing cross-functional development teams in pharmaceutical manufacturing?

As the Head of CMC (Chemistry, Manufacturing, and Controls), one common challenge is coordinating efforts between R&D, regulatory, quality assurance, and manufacturing teams to ensure alignment on timelines and compliance standards. Balancing innovative process development with strict regulatory requirements and managing resource constraints are also frequent hurdles. Effective communication and proactive project management are essential to navigate shifting priorities, address technical issues quickly, and keep all teams focused on delivering high-quality products within set deadlines.

What is the difference between Head Of Cmc vs Cmc Manager?

AspectHead Of CmcCmc Manager
ResponsibilitiesOversees entire CMC development, strategy, and regulatory compliance at a senior levelManages day-to-day CMC activities, ensuring project milestones and quality standards are met
Required CredentialsAdvanced degree in life sciences, extensive industry experience, leadership skillsBachelor's or Master's in related field, relevant industry experience
Work EnvironmentStrategic planning, cross-department collaboration, senior management meetingsOperational tasks, project management, team supervision

The Head Of Cmc typically holds a senior leadership role, focusing on strategic oversight and regulatory compliance, while the Cmc Manager handles daily operational activities. Both roles require relevant industry experience, but the Head Of Cmc's responsibilities are broader and more strategic.

What are Head Of CMC roles and responsibilities?

A Head of CMC (Chemistry, Manufacturing, and Controls) oversees all aspects of the drug development process related to manufacturing and quality. They are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled according to regulatory standards. This role involves leading cross-functional teams, managing relationships with external partners, and ensuring timely submission of regulatory documents. The Head of CMC also plays a key role in problem-solving, process optimization, and maintaining compliance throughout the product lifecycle.

What is a head of CMC?

The head of CMC (Chemistry, Manufacturing, and Controls) is a senior professional responsible for overseeing the development, manufacturing, and regulatory compliance of pharmaceutical products. They ensure that drug development processes meet quality standards and regulatory requirements, often coordinating cross-functional teams and managing documentation for regulatory submissions.

What jobs pay 500,000 a year in the US?

High-level executive roles such as Chief Executive Officers (CEOs), Chief Medical Officers, and some specialized investment bankers often earn annual salaries of $500,000 or more, especially in large corporations or financial firms. These positions typically require extensive experience, advanced degrees, and leadership skills, and compensation may include bonuses, stock options, or other incentives.

What does a CMC leader do?

A CMC (Chemistry, Manufacturing, and Controls) leader oversees the development, manufacturing, and regulatory compliance of pharmaceutical products. They coordinate cross-functional teams to ensure quality, consistency, and adherence to industry standards throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a Head of CMC, and why are they important?

To thrive as a Head of CMC (Chemistry, Manufacturing, and Controls), you need deep expertise in pharmaceutical development, regulatory requirements, and process optimization, typically supported by an advanced degree in chemistry, pharmacy, or a related field. Experience with quality management systems, regulatory submissions (e.g., IND, NDA, BLA), and industry-standard software such as LIMS or ERP platforms is essential. Strong leadership, strategic thinking, and cross-functional communication skills distinguish top performers in this role. These capabilities are critical for ensuring product quality, regulatory compliance, and the successful advancement of drug candidates through the development pipeline.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, with salaries often exceeding $150,000 annually. These roles require extensive experience, leadership skills, and knowledge of industry regulations, often supported by advanced degrees and certifications like RAC (Regulatory Affairs Certification).
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Head Of Cmc jobs near you
Infographic showing various Head Of Cmc job openings in the United States as of July 2026, with employment types broken down into 10% Internship, 1% As Needed, 74% Full Time, 12% Part Time, 2% Contract, and 1% Summer. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution.
Vice President, Head of CMC

Vice President, Head of CMC

Repertoire Immune Medicines

Cambridge, MA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 23 days ago

Job description

Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power of the human immune system to develop transformative therapies for cancer and autoimmune disease. Using its proprietary DECODETM platform—which maps the immune synapse between T cell receptors (TCRs) and their antigen targets—Repertoire translates unique biological insights into potent and targeted off-the shelf immune medicines. The company integrates deep protein engineering expertise with artificial intelligence, powered by a proprietary DECODE database of over one billion TCR-antigen interactions, to accelerate discovery and optimize drug candidates.
From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoire is advancing a pipeline of T cell-targeted immunotherapies with the potential to address a broad range of cancers and autoimmune disorders. The company’s lead oncology program, RPTR-1-201, a TCR bispecific, has initiated a Phase 1/2 clinical trial across multiple solid tumor indications. Repertoire plans to advance additional TCR bispecific therapies into clinical trials over the next 12-18 months. In autoimmune disease, Repertoire is partnering with leading pharmaceutical companies to develop mRNA tolerizing therapies designed to selectively expand regulatory T cells and reset the immune system.
Repertoire was founded in 2019 by Flagship Pioneering and is supported by a strong investor base. The DECODE platform has been validated through four strategic partnerships with leading pharmaceutical companies—Bristol Myers Squibb, Genentech, Eli Lilly, and Pfizer—representing over $4.5 billion in disclosed total deal value and $185 million in upfront payments received to date.
Role Overview
Repertoire Immune Medicines is seeking an accomplished and strategic Vice President, Head of CMC to lead all Chemistry, Manufacturing, and Controls activities across the company’s growing pipeline of protein biologics. This senior leader will be responsible for establishing and executing CMC strategy from development candidate nomination through clinical development.
The successful candidate will bring deep expertise in biologics CMC development, demonstrated success building teams and processes in both early‑stage and mature organizations, and a strong track record of technology transfer and management of external manufacturing organizations. This leader will work cross‑functionally with research, preclinical, clinical, regulatory, quality, and finance teams to ensure successful execution of CMC activities related to regulatory filings, cGMP manufacturing and clinical supply.
Key Responsibilities
CMC Strategy and Leadership
  • Define and execute end‑to‑end CMC strategy aligned with corporate and clinical development objectives.
  • Lead and develop a high‑performing Technical Development Team encompassing upstream, downstream, analytical, and formulation development.
  • Serve as the primary CMC leader for development candidate selection and progression decisions.
Manufacturing and External Partnerships
  • Identify, select, and manage CDMOs and CROs; negotiate manufacturing, quality, and supply agreements in partnership with executive leadership and finance.
  • Lead seamless technology transfer of manufacturing and analytical processes to external partners for non‑GMP and GMP production.
  • Oversee drug substance and drug product manufacturing from development candidate nomination through clinical supply, ensuring on‑time delivery for regulatory submissions and clinical trials.
  • Monitor manufacturing timelines, budgets, and performance; proactively identify opportunities to accelerate development and control costs.
Technical and Quality Oversight
  • Establish critical quality attributes (CQAs), process controls, and fit‑for‑purpose control strategies to ensure product consistency and robustness.
  • Oversee analytical method transfer, method qualification, stability programs, and product shelf‑life assignments.
  • Provide leadership and oversight of QA activities with external QA consultants and quality systems appropriate for company stage.
  • Oversee clinical labeling, packaging, and supply logistics through supervision of clinical supply partners.
Regulatory Support
  • Review technical documentation and reports from CDMOs and CROs.
  • Author and oversee CMC sections of regulatory submissions and amendments.
  • Partner closely with Regulatory Affairs to support health authority interactions related to CMC.
Organizational Leadership
  • Develop CMC operating plans, milestones, and short‑ and long‑term objectives across all pipeline programs.
  • Build scalable systems and processes appropriate for company growth.
  • Influence company culture through collaborative leadership, mentorship, and cross‑functional partnership.
Qualifications and Experience
  • PhD in Biochemistry, Biology, Biotechnology, Chemical Engineering, Biological Engineering, or a related discipline.
  • 15+ years of experience in the pharmaceutical or biotechnology industry, with substantial leadership responsibility in biologics CMC, process development, and manufacturing.
  • Recognized expert in biologics CMC process, development, and strategy, including application of Quality by Design (QbD) approaches to support robust manufacturing processes and consistent product quality across development stages.
  • Proven experience building and leading teams and developing talent in matrixed and outsourced environments.
  • Extensive experience with technology transfer to CDMOs, including cell line development, upstream and downstream process development, analytical method development, scale‑up, and GMP manufacturing.
  • Hands‑on experience with formulation development and stability studies for drug substance and drug product to support regulatory submissions and clinical trials.
  • Strong working knowledge of drug development across research, preclinical, clinical, and regulatory functions.
  • Experience with bispecific proteins, Fc‑fusion proteins, or other complex biologics preferred.
  • Demonstrated ability to author high‑quality technical documentation for regulatory submissions.
  • Exceptional leadership, communication, and stakeholder management skills, with the ability to drive strategic discussions with senior management and external partners.
  • Proven ability to build consensus and solve complex problems across diverse, cross‑functional teams.
  • Willingness to travel domestically and internationally as needed to support CDMO oversight.
The base salary for this role ranges from $204,000 to $292,000 and is determined based on a candidate’s skills, experience, and internal equity. In addition to a competitive base salary, Repertoire offers a broad range of benefits designed to attract, retain, and motivate top talent, including medical, dental, vision, and life insurance, flexible time off, a 401(k) retirement plan, and short- and long-term incentive opportunities. Compensation and benefits are based on Repertoire’s good faith estimate at the time of publication and may be updated in the future.
Repertoire is committed towards social responsibility and developing an inclusive culture. Much as the power of the immune system lies in the diversity of T and B cells, our work requires the creativity and ingenuity of a diverse workforce.  We believe in actively pursuing equity in all facets of the work experience at Repertoire.  We will continue to educate ourselves about the inequities and barriers present in our society and take action as a company where we can make a difference.
Repertoire is proud to be an Equal Opportunity Employer.

Recruitment & Staffing Agencies: Repertoire Immune Medicines (“Repertoire”) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoire’s internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.
 

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