Head of CMC (Chemistry, Manufacturing, and Controls)
The role & responsibilities of the Head of CMC (Chemistry, Manufacturing, and Controls) at Nimbus
Reporting to the Senior Vice President Chemistry, the Head of CMC will provide strategic, technical and tactical expertise and oversight to Nimbus’ small molecule development and manufacturing activities. This includes process chemistry/API generation (drug substance), formulation development, drug product development, tech transfers, pre-clinical and clinical manufacturing, and commercial scale development.
The Head of CMC will:
- Develop and implement a sustainable and adaptable CMC strategy for Nimbus
- Direct preclinical and Phase 1/2 small molecule drug development including process route development, formulation, analytical methods, controls & scale-up
- Own and manage the technology transfer process from research to development of Drug Substance and Drug Product
- Build and maintain a powerful external network of trusted providers of process chemistry, product development and manufacturing partners
- Develop and implement rapid and efficient progress of small molecule candidates to first in human studies
- Create a strategy and track progress of CMC with seamless integration into the broader needs of the development/clinical teams
- Represent CMC at leadership team meetings and board discussions
- Engage with late stage lead optimization teams to select and support the scale-up of synthetic intermediates and route adjustments to the final API
- Integrated member of late stage research teams and all development teams
- Provide the required reports and analyses into regulatory submissions by authoring and reviewing CMC sections of INDs and any other FDA meetings, e.g. type C review meetings
- Ensure compliance within CMC to GMP and GCP standards
Qualifications We Are Seeking
- Ph.D. in Chemistry or Pharmaceutical Sciences or a related molecular discipline such as chemical engineering
- 12+ years of proven track record in small molecule drug development including process chemistry, formulation, drug product development, scale-up and tech transfer
- Experience at overcoming many challenges in CMC development including route-scouting, impurity assessments, compound/IP shipping and packaging
- Expertise in advancing candidate molecules through preclinical to late Phase IIb development and preparation towards NDA filing
- Demonstrated ability to devise and execute integrated, well-coordinated CMC development strategies
- Proven ability to deliver scalable formulations and manufacture prototype dosage forms
- Expertise with process chemistry development and optimization activities including knowledge and experience with state-of-the-art synthetic and biosynthetic methods
- Ability to be both a strategic leader and a hands-on problem solver
- Experience in maintaining and driving a network of active CMC providers (vendors and consultants)
- Demonstrate skillfulness at people/budget management, scientific/business analytics, organization and communication
- Experience managing complex international relationships across diverse culture-specific business practices as well as experience collaborating with internal stakeholders
A Snapshot of Nimbus
Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The company’s LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com.
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Nimbus Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus Therapeutics does not accept unsolicited resumes from any source other than directly from candidates.