Head of Pharmaceutical Development & Manufacturing
The Role & Responsibilities of the Head of Pharmaceutical Development & Manufacturing at Nimbus
Reporting to the Senior Vice President Chemistry, the Head of Pharmaceutical Development & Manufacturing will provide strategic, technical and tactical expertise and oversight to Nimbus’ small molecule development and manufacturing activities. This includes formulation development, API & Drug Product process development, scale-up, tech transfer, pre-clinical and clinical manufacturing, and commercial scale development.
More specifically, the Head of Pharmaceutical Development & Manufacturing will:
- Develop and implement the CMC strategy
- Direct early phase small molecule drug development including formulation, analytical method development & process chemistry
- Own the technology transfer process from research to development by managing API and Drug Product development & manufacturing
- Develop and implement solutions for accelerated small molecule candidate transitions to first in human studies
- Build and maintain an external network of trusted development and manufacturing partners
- Generate the CMC plans & timelines and collaborate with the broader team to ensure successful integration into the project plans
- Represent the department at CMC and project meetings
- Manage vendors and external manufacturing teams to deliver on project timelines and goals
- Support regulatory submissions by authoring and reviewing CMC sections, including INDs, NDAs and IMPDs
- Ensure compliance with regulatory requirements
The Qualifications We Are Seeking
- PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent
- 15+ years of proven track record in small molecule drug development including formulation, process chemistry, drug product development, scale-up and tech transfer
- Extensive expertise advancing candidate molecules from discovery to early phase development and experience in late phase to commercial transitions
- Demonstrated ability to devise and execute integrated, well-coordinated CMC development strategies
- Proven ability to deliver scalable formulations and manufacture prototype dosage forms
- Expertise conducting API and drug product process development and process optimization activities
- Proven ability to achieve manufacturing effectiveness and efficiency
- Ability to be both a strategic leader and a hands-on problem solver
- Experience in building and maintaining a successful, external network of CMC vendors
- Experience in cGMP and CMC IND/NDA/IMPD regulatory filings
- Strong analytical, organizational and communication skills
- Experience managing complex international relationships across diverse culture-specific business practices as well as experience collaborating with internal stakeholders
A Snapshot of Nimbus
Nimbus is a ~ 30 person biotechnology company located in the thriving biotech hub of Cambridge, Massachusetts. We transform drug development by integrating computational drug discovery techniques, a cutting-edge computational chemistry platform and other advanced technologies to design breakthrough medicines for patients.
We focus on promising targets in metabolic disease, oncology and inflammation. These include both emerging and well-validated targets that have proven intractable to others in the pharmaceutical and biotechnology industry.
Nimbus offers a fast-paced, entrepreneurial, team-focused work environment. The culture is intellectually stimulating, flexible and results-oriented. Joining our team offers significant opportunities to grow professionally and personally.
We also offer a top-notch benefits package (health, dental, life, vacation, and employer 401K contribution ). Being part of Nimbus (a Nimbi, if you’re curious), allows you to become part of a small close-knit professional team that strives to bring out the best in each other by working hard and having fun together.