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Head Of Biotech Cmc Jobs (NOW HIRING)

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 ... the biotech/pharma industry * Experience in CMC regulatory lifecycle management, including ...

argenx SE

WI · On-site

$114.22 - $157.05/hr

## Head of Rewards & Recognition, Developed MarketsApplylocations: Gent, Belgiumtime type: Full ... We are building a new kind of biotech company, one that maintains its roots as a science-based ...

Pathos

Director, CMC - Biologics & ADC

New York, NY · On-site

$210K - $250K/yr

... biotech. There is no middle management. There are no layers of approval. The company is designed ... the Head of CMC with Research, Clinical, Regulatory, and Quality colleagues in a fast-moving ...

New

Aspect Biosystems

Head of Quality Assurance

Fremont, CA

$191K - $202K/yr

Biotech Industry Tenure: 10+ years of progressive Quality Assurance leadership experience within a ... Direct experience authoring, reviewing, and approving Quality/CMC sections for regulatory ...

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Head Of Biotech Cmc information

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How much do head of biotech cmc jobs pay per year?

As of Aug 13, 2026, the average yearly pay for head of biotech cmc in the United States is $159,999.00, according to ZipRecruiter salary data. Most workers in this role earn between $150,000.00 and $170,000.00 per year, depending on experience, location, and employer.

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

AspectHead Of Biotech CmcBiotech Cmc Manager
ResponsibilitiesOversees entire CMC strategy, leads cross-functional teams, and makes high-level decisionsManages day-to-day CMC operations, implements plans, and supervises staff
Experience & CredentialsAdvanced degree (PhD/MSc), extensive industry experience, leadership skillsBachelor's or Master's degree, relevant industry experience, technical expertise
Work EnvironmentStrategic, leadership-focused, often in senior management meetingsOperational, project-focused, in labs or manufacturing settings

The Head Of Biotech Cmc typically holds a senior leadership role, responsible for strategic direction and decision-making, while the Biotech Cmc Manager focuses on managing daily operations and project execution within the biotech CMC department.

What skills and qualifications are needed to thrive as a Head of Biotech CMC?

To thrive as a Head of Biotech CMC (Chemistry, Manufacturing, and Controls), you need deep expertise in biotechnology, pharmaceutical development, and regulatory compliance, often backed by an advanced scientific degree. Familiarity with GMP, quality management systems, and regulatory submission platforms like eCTD is typically required. Exceptional leadership, strategic thinking, and cross-functional communication skills help drive complex projects and align multidisciplinary teams. These competencies are essential to ensure product quality, regulatory approval, and the successful scale-up of biotechnological products.

What are the responsibilities of a Head of Biotech CMC?

A Head of Biotech CMC (Chemistry, Manufacturing, and Controls) oversees the development, manufacturing, and quality control of biotechnological products throughout their lifecycle. They ensure that processes comply with regulatory requirements and meet industry standards for safety and efficacy. Their duties include leading cross-functional teams, managing timelines and budgets, and developing strategies for scale-up and technology transfer. Additionally, they play a key role in interacting with regulatory agencies and facilitating the submission of documentation for product approval.

What challenges does a Head of Biotech CMC face when scaling up production from clinical to commercial stages?

One of the key challenges for a Head of Biotech CMC is ensuring that processes developed at the clinical stage can be effectively and compliantly scaled up for commercial manufacturing. This often involves addressing differences in equipment, maintaining product quality and consistency, and navigating regulatory requirements across multiple regions. Additionally, coordinating cross-functional teams—such as R&D, quality assurance, and supply chain—is essential to resolve technical issues quickly and keep projects on track. Proactive communication and robust risk management strategies are critical for success in this role.
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Head Of Biotech Cmc jobs near you
Infographic showing various Head Of Biotech Cmc job openings in the United States as of August 2026, with employment types broken down into 5% Internship, 80% Full Time, 5% Part Time, and 10% Contract. Highlights an 71% In-person, and 29% Remote job distribution, with an average salary of $159,999 per year, or $76.9 per hour.

CMC Director, Regulatory Affairs

Altimmune

Morristown, NJ • On-site

$154K - $204K/yr

Full-time

Re-posted 26 days ago

Job description

Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for treatment of obesity, metabolic dysfunction-associated steatohepatitis (MASH), alcohol-associated liver disease (ALD), and alcohol use disorder (AUD). For more information, please visit www.altimmune.com.

Job Description: This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline development, and regulatory intelligence). 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 applications
  • Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals
  • Responsible for the preparation of all CMC sections/information filed in support of global clinical trial and marketing applications; ensures all CMC regulatory filings are prepared accurately and completed in a timely manner
  • Manages global CMC regulatory projects as assigned and assists in the development of relevant timelines and ensures execution to meet corporate goals
  • Performs regulatory assessments of CMC changes, identifying global regulatory filing requirements
  • Responsible for submission of supporting amendments and updates to relevant applications for CMC-related changes
  • Manages the preparation and submission of formal CMC-related regulatory meeting requests and briefing packages and coordinates meetings with regulatory agencies
  • Leads CMC-related FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's development programs
  • Interprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligence
  • Represents and participates in project/program teams and sub-teams, as required
  • Participates in the development, review, and implementation of departmental SOPs and processes.

Job Requirements (Essential knowledge, skills and attributes):

  • 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 industry
  • Experience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC modules of eCTD submissions
  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies
  • Ability to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing CMC filing requirements for approval of marketing and clinical trial applications for drugs and biological products
  • Excellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
  • Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs)
  • Must be self-motivated with a positive attitude and ability to work well with others
  • Excellent oral and written communication skills.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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