The Director of Drug Product Development (small molecule oral solids dosage) will support expansion of the company’s operations and will support Drug Product projects from all phases of development from pre-clinical to late phase/commercial. This role will report to our Vice President of CMC.
In this role, you will:
- Lead drug product development of oral solid dosage from lead candidate optimization to clinical development and through commercialization
- Provide guidance and oversight of contract manufacturing organizations (CMOs) through technology transfer, formulation and process development, optimization, qualification and validation of activities related to DP manufacturing operations. Be present on the manufacturing site, as necessary.
- Develop phase-appropriate oral solids dosage forms for clinical and commercial use.
- Design and oversee pre-formulation, formulation and process development, scale-up and clinical manufacturing activities, including primary packaging, labeling and distribution.
- Author and review development reports, technical memos, batch records, and relevant CMC sections for various regulatory filings (IND, IMPD, NDA, MAA).
- Participate in vendor selection and contract negotiations with external partners.
- Create and manage drug product risk assessment and risk register.
- Assure suitable forecasts of API and DP needs for the clinical programs to ensure uninterrupted drug supply.
- Serve as a drug product SME on project teams and/or sub-teams.
These Qualifications Will Help This Role Be Successful
- PhD in Pharmaceutical Sciences, Chemical Engineering, or related Physical Sciences with 10+ years of experience, or MS with 12+ years, or working in small molecule oral solids drug product development in the pharmaceutical or biotechnology industry.
- In-depth knowledge and hands-on experience in pre-formulation, formulation and process development of small molecule oral solid dosage forms.
- Proven experience managing scale-up and manufacturing of pharmaceutical dosage forms.
- Thorough understanding of cGMP compliance and ICH guidelines.
- Experience writing CMC drug product sections in regulatory filings.
- Direct experience managing CMOs. GMP experience is required.
- Experience in pre-formulation, formulation development, and manufacturing process selection and scale-up based on Quality by Design principles.
- Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
- Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.
- Positive, adaptable, can-do attitude with quick learning ability.
- A desire to be part of a highly innovative company aimed at helping patients with serious diseases.
Additional preferred qualifications:
- Experience with enabled formulations such as spray dried dispersions.
- Strong understanding of pre-formulation principles including solid-state characterization.
A Snapshot of Nimbus
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create 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. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.
Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
Join Nimbus. We are making a difference and you can too.
Nimbus 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 does not accept unsolicited resumes from any source other than directly from candidates.