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Associate Director, Analytical Development

Associate Director, Analytical Development

Cambridge, MA

 

At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare.  We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease.  We do this by leveraging our one-of-a-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally.  This prolific scientific platform has enabled Blueprint Medicines to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

Job Summary:

Blueprint Medicines seeks an exceptional candidate for an Associate Director 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 one or more projects to support Drug Substance (DS) and Drug Product (DP) development, from pre-clinical development to product launch
  • Influence the scientific and strategic direction of development projects
  • Anticipate and pro-actively address internal and/or external scientific challenges or regulatory issues
  • Oversee method development, validation, and transfer activities both internally and through CROs/CMOs
  • In collaboration with other CMC and Non-Clinical functions, develop phase-appropriate control strategies for drug substances and drug products
  • Author, manage, and coordinate AD related sections for regulatory submissions in collaboration with CMOs and internal stakeholders
  • Influence the selection, purchase, and installation of new laboratory equipment
  • May manage a team of analytical chemist

Qualifications:

  • PhD in analytical chemistry or related discipline with 10+ years or BS/MS with 15+ 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:

  • A 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 solve complex problems drawing on a broad knowledge analytical techniques and drug development
  • Ability to motivate self and others to deliver analytical methods, reports, and submissions within the project timelines
  • Comfortable working in a results-driven, highly accountable environment where you can make a clear impact
  • Communicates in an open, clear, complete, timely and consistent manner

 

All applicants will receive consideration for employment without regard to race, age, 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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