Nimbus has an outstanding opportunity for an exceptional Director of Analytical Development and Quality Control to join our team. This role will contribute to the overall CMC strategy of drug development and provide analytical and bioanalytical development of small molecule candidates in preclinical and clinical development for both drug substances and drug products. You will report to our Vice President of CMC.
In this role, you will:
- Guide CRO/CDMO to design and perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity and dissolution methodologies, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization
- Develop phase-appropriate quality control strategy for drug substance and drug products
- Manage product stability study programs
- Guide CRO to develop and validate GLP bioanalytical methods to support DMPK, Toxicology and clinical studies
- Author analytical development and validation reports and analytical sections in IND and NDA filings Precise coordination with QA and Regulatory, as well as other CMC functions, clinical and toxicology, regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing
- Serve as the CMC representative in cross functional project teams
These Qualifications Will Help This Role Be Successful
- PhD in analytical chemistry with 10+ years or MS with 12+ years of analytical development experience in the pharmaceutical industry
- Excellent scientific knowledge in analytical chemistry and organic chemistry
- Experience in managing CROs and CDMOs, preferably on both analytical and bioanalytical projects
- Thorough understanding of cGMP compliance and ICH guidelines
- Experience in drafting analytical sections of INDs and NDAs. Experience in drafting, reviewing and submitting required documentation pertaining to the cGMP and GLP environment
- A proven track record of implementing phase appropriate quality control strategies
- Demonstrated a proven track record of managing CROs and CDMOs in developing methods and quality control strategy for testing of small molecule drug candidates
- Experience with IND filing, and NDA submission are desired.
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment.
- Effective verbal and written communication skills
- Ability and track record of successfully working in cross-functional teams to progress projects as a representative of CMC function
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment
- A desire to be part of a highly innovative company aimed at helping patients with serious diseases
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.