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Scientist, Analytical Development

Blueprint Medicines is a top-tier, publicly-traded (BPMC) Biopharmaceutical Company focused on discovering, developing and commercializing highly-selective kinase inhibitors for genomically defined diseases.  Originally funded by Third Rock Ventures, the company has built a sophisticated genomics platform and a one-of-kind annotated compound collection which is delivering a pipeline of novel therapies.  In just three years, four programs have been established in genomically defined cancers and one program in the rare genetic disease space.

Job Summary:

Blueprint Medicines seeks an exceptional candidate for a 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:

  • Lead the analytical needs for pipeline compound(s) to support Drug Substance (DS) and Drug Product (DP) development, from pre-Development Candidate stage to product launch
  • Design and perform or manage the method development, validation, and transfer activities both internally and through Preferred Provider CROs/CMOs
  • Author and/or review analytical protocols and technical reports
  • In collaboration with other CMC and Non-Clinical functions, develop phase-appropriate quality control strategies, including specifications, for drug substances and drug products
  • Work with Regulatory Affairs and 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 3+ years or BS/MS with 6+ 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 manne

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.

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