Director, CMC Product Development
Join our journey towards better therapies
Do you want to join an exciting biotech company and play a key role in advancing cutting-edge antibody therapies for life-threatening diseases? Do you bring deep expertise in CMC development of biologics, a strategic mindset combined with hands-on execution, and thrive in a dynamic start-up environment? If so, we would love to hear from you.
About Commit Biologics
Commit Biologics is a pioneering biotech company developing next-generation complement-powered immune engagers for the treatment of a range of serious diseases including cancers and autoimmune diseases. We are advancing a growing pipeline of innovative biologics toward clinical development and are seeking a highly experienced CMC Director to lead our Chemistry, Manufacturing, and Controls strategy.
The position
As CMC Director, you will be responsible for defining and executing the CMC strategy across our pipeline, from late discovery through clinical development. You will play a critical role in ensuring robust, scalable, and regulatory-compliant manufacturing processes to support clinical trials.
This is a hands-on leadership role requiring both strategic oversight and operational execution in a dynamic biotech environment.
The position will report to the head of Commit R&D.
Location: Copenhagen or Aarhus, Denmark
Key responsibilities
· Define and lead the CMC strategy for multiple biologics programs
· Oversee process development, scale-up, and manufacturing (drug substance and drug product)
· Manage and coordinate CDMOs and external partners
· Ensure preparation and delivery of high-quality CMC documentation for regulatory submissions (IND/CTA, IMPD, BLA)
· Lead technology transfer and manufacturing readiness for clinical supply
· Establish and maintain quality standards
· Drive analytical development and comparability strategies
· Contribute to regulatory interactions and health authority responses
· Build and manage internal CMC capabilities as the company grows
Qualifications
· PhD, MSc, or equivalent in biochemistry, biotechnology, pharmaceutical sciences, or related field
· 10+ years of experience in CMC development of biologics, preferably antibodies
· Proven track record advancing programs from preclinical into clinical development
· Strong expertise in bioprocess development, manufacturing, and analytical characterization
· Experience working with CDMOs and global regulatory agencies (FDA, EMA)
· Deep understanding of GMP requirements and regulatory expectations
· Ability to operate both strategically and hands-on in a fast-paced biotech setting
Personal Profile
· Collaborative and solution-oriented mindset
· Strong leadership and stakeholder management skills
· Ability to balance scientific rigor with pragmatic decision-making
· Comfortable working in a growing, entrepreneurial environment
Why Join Commit Biologics?
· Be part of a cutting-edge immunotherapy platform with strong differentiation
· Work alongside a highly experienced and scientifically driven team
· Influence key development decisions and company strategy
· Competitive compensation and equity package
· Flexible and international working environment
Contact and application process
At Commit Biologics, we view diversity as a strength and warmly encourage all qualified individuals regardless of personal background to apply.
To apply, kindly submit your application to carreer@commitbio.com. We look forward to receiving your application no later than May 15, 2026. Interviews will be conducted on a rolling basis, and we reserve the right to close the recruitment process once the right candidate has been found.
If you have any questions regarding the position or our organization, please feel free to reach out through carreer@commitbio.com.
