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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 position?

A CMC (Chemistry, Manufacturing, and Controls) position in biotech involves overseeing the development, manufacturing, and quality control of biopharmaceutical products. Professionals in this role ensure that products meet regulatory standards and are produced consistently, often requiring knowledge of GMP (Good Manufacturing Practice) and regulatory guidelines.

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, producing, and ensuring the quality of a biopharmaceutical product. CMC professionals are responsible for regulatory compliance, process validation, and quality assurance to meet industry standards and facilitate product approval.

What is the CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes ensuring the quality, safety, and efficacy of a biotech product throughout development and production. Professionals in this field often work on regulatory submissions, quality assurance, and process validation to meet industry standards.

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Infographic showing various Cmc In Biotech job openings in Oregon as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 4% Part Time, 1% Temporary, and 7% Contract. Highlights an 80% Physical, 4% Hybrid, and 16% Remote job distribution.

Associate Director, Regulatory CMC

Praxis Precision Medicines, Inc.

OR • On-site, Remote

Full-time

Posted 6 days ago

Job description

Location: This position may be performed remotely but requires flexibility and a willingness to travel as needed. 

Position Summary 

The Associate Director, Regulatory CMC will be responsible for the planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products, including small molecule and antisense oligonucleotide (ASO) programs. This role will work closely with cross-functional partners and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management activities. 

The ideal candidate is a hands-on regulatory professional with strong CMC technical knowledge, a proactive ownership mindset, and a commitment to excellence, who thrives in a fast-paced biotech environment, takes full accountability for assigned programs, effectively partners with cross-functional teams, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes. 

Primary Responsibilities 

  • Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director. 
  • Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements. 
  • Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams. 
  • Support health authority interactions including briefing documents and information request responses. 
  • Maintain regulatory compliance for CMC activities supporting clinical and commercial supply. 
  • Assist with post-approval change management, comparability assessments, manufacturing changes, and technology transfers. 
  • Manage external consultants, CMOs, CROs, and regulatory vendors. 

Qualifications and Key Success Factors 

  • Bachelor's, Master's, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant scientific discipline; 10+ years of progressively responsible experience in Regulatory CMC and/or technical CMC, or an equivalent combination of advanced education and experience. 
  • Demonstrated technical CMC expertise gained through hands-on experience as a subject matter expert in one or more CMC disciplines (e.g., formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality), with the ability to independently interpret complex scientific and manufacturing data and translate technical conclusions into sound regulatory strategies. 
  • Extensive hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions, with strong knowledge of FDA and global CMC regulatory requirements across development and commercial stages. 
  • Experience supporting small molecule drug products; experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred. 
  • Demonstrated leadership of complex CMC regulatory activities, including health authority interactions, and the ability to influence cross-functional teams, build consensus among technical SMEs, and effectively work with external manufacturing, testing, and other development partners. 
  • Demonstrated ownership mindset with a proactive, can-do attitude and strong commitment to excellence; takes full accountability for assigned Regulatory CMC programs, anticipates and independently resolves complex issues, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes. 
  • Strong project management, organizational, written, and verbal communication skills, with the ability to manage multiple programs and priorities effectively in a fast-paced, cross-functional environment. 
  • Proficiency in leveraging AI tools and other digital technologies to enhance document preparation, review, data analysis, and day-to-day Regulatory CMC activities while maintaining scientific judgment, data integrity, confidentiality, and compliance with company policies. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

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