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Senior Specialist, GMP Quality Assurance

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 currently seeking a Senior Specialist, GMP Quality Assurance.  This individual will have responsibility for supporting process validations, lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional will assure company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards established by company as well as regulations of applicable authorities.  Reporting to the Director of Quality Operations, the candidate will have an opportunity to join a rapidly growing Quality Organization and assist in the development and implementation of quality systems and processes.

Responsibilities:

  • Support process validation activities, review validation protocols and reports
  • Represent Quality Operations on CMO project teams, manage relationships with CMO’s.  This may include periodic visits to CMO’s, as required
  • Manage review of product release and stability data, support method transfers and validations.
  • Conduct activities in support of clinical and commercial product release for drug substance, drug product, and finished goods for all phases of development including review and approval of Master Batch Records along with executed records
  • Work with CMO’s and Blueprint management to raise/resolve change controls, deviations and investigations.
  • Support Quality Management Reviews
  • Provide input and support for the development and improvement of quality operations processes
  • Provide QA support for regulatory filings
  • May support supplier audits and regulatory inspections
  • Establish and maintain effective working relationships with key internal and external stakeholders

Qualifications:

  • Bachelor’s degree in biology, chemistry, life sciences or related field.   3-5 years of GMP quality experience preferably a virtual Pharmaceutical/Biotech setting. Validation and commercial experience preferred
  • Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations.
  • Exercises judgment within broadly defined practices and policies in determining solutions and actions.
  • Demonstrates ability to identify and recognize quality issues that will result in critical delays in schedule or operations and may jeopardize overall business activities.
  • Knowledge of drug substance, drug product, finished goods; and solid dosage manufacturing principles, equipment and processes.
  • Experience in packaging, labeling, and distribution for commercial launch and/or post approval preferred.   

Capabilities:

  • Ability to effectively prioritize and support multiple projects and tasks
  • Strong interpersonal and communication skills
  • 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 may 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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