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CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...

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Cmc In Biotech information

How is CMC used in pharmaceuticals?

In the context of CMC (Chemistry, Manufacturing, and Controls) in biotech jobs, CMC involves developing and controlling the processes for producing pharmaceuticals, ensuring product quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, often requiring knowledge of regulatory requirements and laboratory skills.

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that drugs are manufactured consistently, meet quality standards, and comply with regulatory requirements, often working with laboratory techniques, quality assurance, and regulatory submissions.

What is the highest paying job in biotech?

In biotech, senior executive roles such as Chief Scientific Officer (CSO) or Vice President of Research typically have the highest salaries, often exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and leadership skills in research and development environments.

What are CMC jobs?

CMC jobs in biotech refer to roles involved in Chemistry, Manufacturing, and Controls activities, which ensure the quality, safety, and efficacy of biopharmaceutical products. These positions often require knowledge of regulatory requirements, laboratory skills, and experience with process development and validation. CMC professionals play a critical role in drug development and manufacturing compliance.
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Infographic showing various Cmc In Biotech job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 1% Part Time, 4% Contract, and 9% Summer. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution.

Director/Associate Director, Cell Therapy CMC & Manufacturing

QLD Biotherapeutics Inc

Boston, MA

Full-time

Posted 27 days ago

Job description

Director/Associate Director, Cell Therapy CMC & Manufacturing

We are seeking a highly experienced and visionary leader of CMC & Manufacturing to lead our cell therapy development programs. The successful candidate will help lead CMC strategy, manage process development and manufacturing activities, and play a key role in advancing programs into first-in-human clinical trials. This role requires demonstrated success in bringing at least one cell therapy program from preclinical through IND and into clinical trials.

Key Responsibilities

  • Lead/support the development and implementation of CMC strategy for cell therapy programs.
  • Lead process development and optimization for iPSC- or MSC-derived products and drive process development, scale-up, and tech transfer.
  • Contribute to regulatory filings (CMC sections of IND/CTA).
  • Collaborate with CMC, R&D, QC, QA, and clinical teams across China and the U.S. to ensure a seamless transition from preclinical to clinical development.
  • Support resource planning, budgeting, and project management for CMC deliverables.
  • Provide strategic leadership to ensure clinical readiness and robust supply chain for first-in-human studies.

Qualifications

  • PhD (preferred) or MS in Cell Biology, Immunology, Bioengineering, or related field.
  • 8+ years of biotech/pharma experience with at least 5 years in cell therapy CMC leadership.
  • Hands-on experience with iPSC/MSC biology, process development, and GMP compliance.
  • Proven track record of advancing programs into IND/clinical development.
  • Deep knowledge of GMP regulations, regulatory expectations, and cell therapy manufacturing platforms.
  • Excellent leadership, communication, and cross-functional team management skills.
  • Strong interpersonal and communication skills; ability to thrive in a fast-paced, collaborative biotech environment.
  • Strong leadership, project management, and cross-functional communication skills.

We are an equal opportunities employer and welcome applications from all qualified candidates.

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