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Associate Director, Process Chemistry

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-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 Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

Blueprint Medicines seeks an exceptional candidate for an Associate Director of Process Chemistry Research and Development.  This position reports into the Director of Process Chemistry R&D. The right candidate will possess an in-depth understanding of small molecules DS-related activities.

Responsibilities:

  • Oversee late phase drug development with Contract Development and Manufacturing Organizations (CDMOs) including Process Performance Qualification (PPQ)
  • Design and oversee  supporting experiments including Fate, Spike and Purge studies,  and DOE to enable PPQ
  • Work with internal and external teams, as well as preferred CDMOs to manage and deliver high quality chemical processes for API delivery
  • Proactively work to manage vendors with regard to scope, timelines, and deliverables
  • Represent Process Chemistry R&D on CMC Subteams with potential to lead
  • Drafting and reviewing of technical and GMP documents, scientific manuscripts, CMC-regulatory documents for regulatory filings and patent applications
  • Work closely with Medicinal Chemists to ensure synthetic route, pharmaceutical form, and compound properties are appropriate for development
  • Support drug substance scale-up, GLP, and GMP manufacturing activities
  • Oversee the design, planning, and execution of multi-step organic syntheses of small molecules as a member of cross-functional development teams

Desired Skills and Experience

Master’s degree in organic chemistry, in addition to 15-20 years of applicable experience in a pharmaceutical or biotechnology industry role is required

OR 

PhD (or Postdoc) in organic chemistry in addition to 8-12 years of experience in a pharmaceutical or biotechnology industry role is required

Capabilities:

  • Preparation of CMC documents suitable for regulatory filings including New Drug Applications
  • Experience in API manufacturing and PPQ associated with small molecules in clinical development
  • Management of drug substance development and manufacture under an outsourcing model
  • Management of on-time API deliveries for drug safety studies, formulation development, preclinical, and clinical studies
  • Experience with technology transfer and outsourced work on process development, kilo-lab preparation, and plant production
  • Provides scientific guidance to CMO’s on the assigned programs; helps trouble-shooting development and production issues.
  • Management and mentorship of laboratory personnel
  • 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

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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