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Position:
Vice President of CMC

Employer:
Nura Bio

Description:

Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio's research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system. 

We are seeking a dynamic and experienced Vice President of CMC to lead and oversee all aspects of Chemistry, Manufacturing, and Controls for our drug development programs. As a senior leader, you will drive the strategic and operational direction of CMC activities, ensuring alignment with regulatory requirements and corporate objectives. This role will play a critical part in advancing our pipeline from early-stage development through commercialization. 

Nura Bio offers a comprehensive generous medical and dental insurance, vision, life and disability insurance, health savings account, flexible savings, and dependent care, 401(k) plan, and highly attractive stock options. 

Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment. 

To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!

Please send your CV with a cover letter delineating why you are interested to joinus@nurabio.com

 



Qualifications/Experience:

What You Will Do:

The Vice President of CMC, reporting to Sr. Vice President of Development Sciences, will lead the CMC function and oversee the execution of CMC activities of small molecule therapeutics in development. The CMC activities include development of chemical processes for and manufacturing of drug substances, formulation development and product maufacturing, and management of clinical trials (CTMs). This individual will also contribute to discovery pharmaceutics and assist with the selection of development candidates. Specific responsibilities include, but are not limited to the following:

  • Plan and manage development of chemical processes and manufacturing of drug substance, formulation dvelopment and product manufacturing, CTM activities, and development and validation of analytical methods for drug substance and product
  • Oversee release testing of drug substance, CTMs; review and QC testing results; work with others to resolve any manufacturing or analytical issues
  • Oversee stability studies of drug substance and drug product, including review and approval of stability protocol, stability data and reports
  • Provide technical input to and/or create specifications for drug substance and drug product; recommend and justify retest data and/or shelf life drug substance and drug product
  • Lead the preparation and review of CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs) and interact with regulatory agencies to address inquiries
  • Ensure reliable supply chain operations, including vendor selection, contract negotiation, and management of external manufacturing partners (CMOs)
  • Collaborate with Quality Assurance to establish and maintain GMP compliance across all CMC activities
  • Provide early pharmaceutics and formulation input to discovery project teams
  • Other project support as needed

What You Will Bring:

  • Ph.D in Chemistry or pharmaceutical sciences with minimum 15 years of experience in the CMC of small molecule therapeutics
  • Deep expertise in drug substance and drug product development, manufacturing, and regulatory submissions
  • Knowledge and understanding of GMP and GXP guidelines and regulatory requirements with respect to drug substance, drug product and/or CTMs
  • A track record of management of CMC activities internally and externally
  • Exceptional leadership qualities, cultivate strategic thinking, communicate clearly, decision and problem-solving skills, working independently, and build open and collaborative relationships with key stakeholders (internal, board, external)
  • Ability to thrive in a fast-paced, entrepreneurial environment with a hands-on approach


Location: South San Francisco, CA

Contact: joinus@nurabio.com

Post Date: 1/27/2025 9:36:05 AM
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