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Senior Scientist, Analytical Development

Job Summary:

Blueprint Medicines seeks an exceptional candidate for a Senior Scientist of Analytical Development, Small Molecules (ADSM) position to work in the analytical development 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 experience in managing CROs and CMOs in analytical method development/validation/transfer and stability testing in 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.   

Responsibilities:

  • Accountable for Analytical Development, Small Molecule (ADSM) activities for pipeline compound(s) to support Drug Substance (DS) and Drug Product (DP) development, from pre-Development Candidate stage to product launch
  • Implement QbD approach(es) to provide analytical support to DS and DP development and manufacturing
  • Manage ADSM-related activities through Preferred Providers relationships
  • Develop phase-appropriate quality control strategies for drug substances and drug products
  • Author and/or review analytical development and validation reports
  • In close collaboration with other CMC and Non-Clinical functions, develop and implement phase-appropriate specifications and generate specification justification reports
  • Work with Regulatory Affairs/Publishing Preferred Provider CROs/CMOs to author, manage, and coordinate ADSM-related sections for IND/CTA submissions

Qualifications:

  • PhD in analytical chemistry or related discipline with 5+ years or BS/MS with 10+ years small molecule analytical development experience in the pharmaceutical industry
  • Comprehensive understanding of analytical development, regulatory, and quality requirements, including GMPs and ICH guidelines, and extensive knowledge of state-of-the-art analytical technologies
  • Experience in managing analytical outsourcing activities at CROs and CMOs

Capabilities:

  • 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
  • Ability to work in a small company, ability to work under extremely tight timelines
  • At home in a results-driven, highly accountable environment where you can make a clear impact
  • A team player, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner
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