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Cmc Biotech Jobs (NOW HIRING)

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

Lead and execute global CMC regulatory strategies for assigned programs across all phases of ... in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs ...

Atomic

CMC Consultant

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 ...

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How much do cmc biotech jobs pay per hour?

As of Aug 3, 2026, the average hourly pay for cmc biotech in the United States is $28.94, according to ZipRecruiter salary data. Most workers in this role earn between $21.39 and $33.41 per hour, depending on experience, location, and employer.

What are CMC Biotech professionals?

CMC Biotech professionals specialize in Chemistry, Manufacturing, and Controls (CMC) within the biotechnology industry. They are responsible for developing, manufacturing, and ensuring the quality and regulatory compliance of biopharmaceutical products from early development through commercialization. Their work includes process development, scale-up, analytical testing, and creating documentation for regulatory submissions. CMC experts play a crucial role in bringing safe and effective biotech therapies to market.

What are some common challenges faced by CMC Biotech professionals when working cross-functionally with other departments?

CMC (Chemistry, Manufacturing, and Controls) Biotech professionals often collaborate closely with teams in research, quality assurance, regulatory affairs, and production. A common challenge is aligning timelines and expectations across departments, as regulatory requirements and quality standards may evolve during product development. Effective communication and proactive project management are crucial to ensure that all teams are aligned, especially when handling complex data or responding to regulatory feedback. Building strong cross-functional relationships and maintaining flexibility can help CMC professionals successfully navigate these challenges.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the documentation and processes ensuring the quality, safety, and efficacy of a biotech product throughout development and production. Professionals working in CMC roles are involved in formulation, process development, quality control, and regulatory compliance to meet industry standards. These roles often require knowledge of Good Manufacturing Practices (GMP) and relevant regulatory guidelines.

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, and they oversee research and development strategies within biotech companies.

What are CMC jobs?

CMC jobs refer to roles in Chemistry, Manufacturing, and Controls within the biotech or pharmaceutical industry, focusing on developing and ensuring the quality of drug products. These positions often require knowledge of regulatory standards, laboratory skills, and experience with documentation and validation processes.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) Biotech professional, and why are they important?

To thrive as a CMC Biotech professional, you need a strong background in biochemistry, molecular biology, regulatory affairs, and process development, often supported by an advanced degree in life sciences or chemical engineering. Familiarity with regulatory submission tools (such as eCTD), quality management systems, and analytical instrumentation is critical. Strong project management, attention to detail, and cross-functional communication skills help ensure effective collaboration and compliance. These competencies are essential for developing safe, effective biotech products while meeting stringent regulatory standards.

What biology jobs pay over $100k?

In the biotech field, roles such as senior research scientist, bioprocess engineer, and regulatory affairs director often pay over $100,000 annually. These positions typically require advanced degrees, specialized skills in laboratory techniques or regulatory compliance, and several years of experience.
More about Cmc Biotech jobs
What states have the most Cmc Biotech jobs? States with the most job openings for Cmc Biotech jobs include:
What job categories do people searching Cmc Biotech jobs look for? The top searched job categories for Cmc Biotech jobs are:
Cmc Biotech jobs near you
Infographic showing various Cmc Biotech job openings in the United States as of July 2026, with employment types broken down into 2% As Needed, 90% Full Time, 1% Part Time, 1% Temporary, and 6% Contract. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution, with an average salary of $60,196 per year, or $28.9 per hour.

Director, CMC Regulatory Affairs

Vir Biotechnology

San Francisco, CA • On-site

$195K - $272K/yr

Full-time

Medical, Retirement, PTO

Re-posted 8 days ago

Job description

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
Vir Biotechnology is seeking an a highly motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. You should bring both a track record of successful regulatory submissions that demonstrates core capability in technical (CMC) development, as well as a passion to challenge conventional paradigms and influence global Health Authorities. We are looking for someone with experience or willingness to expand to cover multiple modalities. The ideal candidate will contribute to a culture of high performance, empowerment, continuous learning and diversity and inclusion. This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and lead high quality regulatory submissions to health authorities.
This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.
WHAT YOU'LL DO
  • As a member of the CMC project teams, provide strategic CMC regulatory leadership to develop and execute sound regulatory strategies that meet global regulatory requirements and enable Vir business objectives
  • Provide CMC regulatory expertise to enable global development and registration for INDs, CTAs, BLAs and MAAs
  • Identify and communicate regulatory risks and facilitate the development and execution of risk mitigation strategies in concert with Technical Operation functions
  • Plan strategy for and lead HA interactions for CMC specific issues
  • Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable)
  • Ensure overall dossier compliance with regulatory requirements
  • Ensure compliance with internal SOP's and policies
  • Contribute to regulatory excellence by identifying opportunities and supporting continuous improvement

WHO YOU ARE AND WHAT YOU BRING
  • B.S., M.S., Ph.D. or other relevant advanced degree or certificate
  • 10+ years experience in pharmaceutical product development including strong global Regulatory CMC leadership
  • Regulatory CMC experience leading both development projects (IND/CTA) and initial registration (BLA/MAA)
  • Experience with CMC regulatory considerations for late stage and/or commercial large molecules (biologics) is required experience with combination product or oligonucleotide experience is a plus
  • Preference will be given to candidates with recent experience with initial BLA and/or NDA (CMC sections). Management of US post-market, biologic product CMC changes is a plus
  • Experience with Health Authority interactions is desirable
  • Thorough understanding of major FDA, EMA, ICH, EudraLex CMC guidelines
  • Global clinical filing experience (US, EU, UK, CA,). Working knowledge of other global clinical territories procedures a plus
  • Ability to effectively present to Senior Management

#LI-AS1
#LI-Onsite
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $195,500 to $272,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
For hires based in the United States, Vir Biotechnology, participates in E-Verify.
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