Blueprint Medicines seeks an exceptional candidate for a Director of Analytical Development position to help build, grow, and lead the analytical function within CMC and contribute to the overall CMC strategy of drug development at Blueprint. The ideal candidate is expected to support analytical development of small molecule candidates from pre-Development Candidate stage through NDA for both drug substances and drug products. Specifically, the ideal candidate will have a proven track record of managing CROs and CMOs successfully in developing methods, supporting drug substance and drug product development, and implementing phase-appropriate control strategies for small molecule drug candidates. Experience with IND/CTA authoring/filing, Regulatory Agency interactions, and NDA submissions desired. Experience in growing and developing internal Analytical Development capabilities and CMC project management are a plus.
- Responsible for all Analytical Development strategy development and activities to support Drug Substance (DS) and Drug Product (DP) from pre-Development Candidate stage to product launch
- Grow and develop Analytical Development department, including hiring headcount per approved growth plans and development of internal laboratory analytical development and support capabilities
- Manage all aspects of Analytical Development-related Preferred Providers relationships
- Develop phase-appropriate quality control strategies for drug substances and drug products
- In close collaboration with other CMC and Quality departments, develop and implement phase-appropriate specifications and generate specification justification reports
- Demonstrate extensive knowledge in state-of-the-art analytical technologies including familiarity with QbD approaches to provide analytical support to DS and DP development and manufacturing
- Manage Analytical Development CMC-related program specific development plans and timelines
- Work with Regulatory Affairs/Publishing Preferred Provider CRO’s to author, manage, and coordinate Analytical Development documents, including sections for IND/CTA/NDA submissions and analytical development-related protocols, studies, and reports
- Work with Regulatory Affairs and Quality Operations to ensure ADSM strategies adhere to current and evolving ICH and regional regulatory guidelines, and to contribute to phase appropriate CMC-related meetings with Health Authorities
- PhD in analytical chemistry or related discipline with 8+ years or BS/MS with 12+ years small molecule analytical development experience in the pharmaceutical industry
- Comprehensive understanding of analytical development, regulatory, and quality requirements, including GMPs and ICH guidelines
- Experience in managing analytical outsourcing activities at CROs and CMOs
- Proven track record of implementing phase-appropriate control strategies to support drug substance and drug product development
- Ability and track record of successfully working in cross-functional teams to progress projects as a representative of CMC team and/or CMC team leadership
- Exceptional project management and people skills
- Ability to work in a small company, ability to work under extremely tight timelines
All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
WHO WE ARE:
Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.
We don’t think in small steps. We think in giant leaps.
We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.
We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.