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Manager, Quality Operations

Job Summary:

Blueprint Medicines is a top-tier, innovative, public 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 one-of-kind annotated compound collection which is delivering a pipeline of novel therapies, and a sophisticated genomics platform.

We are seeking an exceptional candidate for a Manager of Quality Operations.  Reporting to the Director of Quality Operations, the candidate will have an opportunity to join a rapidly growing Pharmaceutical Sciences organization, manage product quality for multiple products in various phases of development and assist in the development and implementation of quality operations processes and procedures. 

Responsibilities:

  • Oversight of the quality activities associated with manufacturing, testing and disposition of clinical materials
  • Represent Quality Operations on CMC and CMO project teams, identify and provide input on quality issues
  • Manage review of product release and stability data, support method transfers and validations.
  • Review and approve API and drug product and packaging batch records (master and executed), perform disposition of clinical products in multiple phases of development
  • Provide quality expertise, advice and/or assistance across the organization as required
  • Provide input and support for the development and improvement of quality operations processes
  • Support review of CMC documents for regulatory filings
  • Lead or support external supplier audits
  • Establish and maintain effective working relationships with key internal and external stakeholders

Qualifications:

  • B.S degree in life sciences, chemistry or equivalent and 5+ years GMP quality experience in a virtual Pharmaceutical/Biotech setting
  • Experience managing relationships with contract manufacturers and testing labs
  • Experience with small molecule and solid oral dosage forms
  • Knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing and testing

Capabilities:

  • Ability to effectively prioritize and manage multiple projects and tasks
  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk based decisions
  • 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
  • Domestic and international travel will be required (5-10%)

 

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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