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Sr. Scientist, Formulation

Job Summary:

Blueprint Medicines is seeking an exceptional candidate for a Scientist of Formulation Sciences.  The candidate will contribute to the planning and execution of all activities related to the development and manufacturing of small molecule oral drug formulations, in support of Blueprint Medicines’ pre-clinical and clinical programs.

Responsibilities:

  • Ensure optimal formulation and manufacturing principles, theories, and techniques for product development are applied to deliver phase-appropriate formulations to support non-GLP and GLP pre-clinical studies, clinical development, and commercial needs
  • Develop and execute on late-stage strategies to support aggressive project timelines
  • Manage and collaborate with multiple CROs and CMOs during various phases of pharmaceutical development, including drug substance characterization and drug product manufacturing, GLP and GMP, for small molecules.
  • Manage DP CMC-related program-specific development plans and timelines.
  • Represent Formulation Sciences and Pharmaceutical Sciences on multidisciplinary project teams, working collaboratively to ensure project progression
  • Oversee DP scale-up and GMP manufacturing
  • Collaborate with Quality operations to review and approve master and executed batch records, manage variances and oversee investigations.
  • Coordinate and collaborate with Process Chemistry and Supply Operations to monitor and plan appropriately to support drug product clinical needs.
  • Work with Regulatory Affairs/Publishing Preferred Provider CRO's to author, manage and coordinate DP-related sections for IND/CTA submissions
  • Establish and maintain effective working relationships with key internal and external stakeholders.

Qualifications:

  • PhD in pharmaceutics, chemical engineering or material sciences with 5+ years or Masters degree with 8+ years as a team member of various drug development programs.
  • Experience managing relationships with CROs, CMOs and testing labs.
  • Knowledge of small molecule and solid oral dosage forms.
  • Experienced in late stage program development including process validation

Capabilities:

  • Comprehensive understanding of the drug product formulation process, quality and regulatory development
  • Comprehensive understanding of the physical and chemical characterization of molecules, including solid state and solution properties.
  • Knowledge of late stage development requirements, including registration stability and process validation strategies
  • Experience with technologies to enhance poorly soluble and/or bioavailable candidates and the physical and chemical characterization of molecules
  • Ability to effectively prioritize and manage multiple projects and tasks
  • 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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