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.
This is an excellent opportunity to develop the GMP/GLP QC function at Blueprint Medicines and support the development and implementation of GMP/GLP quality systems to ensure that Blueprint’s testing and control strategy is in compliance with US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials. Reporting to VP of Quality, the Director of QC will provide oversight of third party GMP and GLP contract testing labs including but not limited to technical transfer, method qualification and validation as well as routine GMP testing (in process, lot release and stability testing). The Director of QC will support the portfolio of clinical development programs to ensure timely delivery of clinical supplies and will assemble, review and trend release, IPC, and stability data, generating reports as necessary to support specification and expiry setting. Analytical method support will include but will not be limited to continuous monitoring of method performance (e.g., control charting, invalid rates, etc.), investigation/OOS management, data integrity reviews, and authoring and/or review of relevant sections of IND/NDA and APQR (i.e., IPC/raw materials testing and control, method validation, specifications, batch analysis, reference standard, and stability).
- Ensure successful technical transfer, method validation and routine GMP and GLP testing in collaboration with Analytical Development and external QC test labs
- Support the development and management of QC specifications for in-process, release and stability testing programs
- Ensure all GMP and GLP testing is conducted in accordance with SOPs, compendia, approved methods, and in accordance with the company’s and regulatory agencies’ policies and procedures
- Direct aspects of contract GMP and GLP testing labs including finished product, in-process, raw material, and stability testing
- Support the development of QC systems and SOPs, such as sample management, shipping, release testing and laboratory investigations
- Work independently to review and trend QC data, generating stability and other trending reports as necessary
- Prepare, analyze and trend QC data
- Support QC deviations, investigations, analytical method performance trending and work with external testing laboratories on root cause analysis and investigation actions.
- Participate in regulatory agency inspections, and assists in observational resolutions, as needed and
- Prepare appropriate sections of regulatory filings and performs data integrity reviews as necessary.
- A Bachelor’s Degree in Chemistry, Biochemistry or a related discipline with at least 10 years of relevant industry experience
- Experience validating methods and monitoring commercial method performance
- Experience drafting protocols, data reports and QC/QA compliance documents required
- Experience with statistical analysis of analytical data and stability studies preferred
- Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration, team-building skills and communication skills
- Independently motivated and detail-oriented with good problem solving ability
- Demonstrated effective time management skills
- Strong professionalism and interpersonal skills
- Sound judgment and commitment to ethical conduct
- Must be willing to travel domestically and internationally up to [15-20%]
- Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
- Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
- Effective Planning – Embedding discipline and thoroughness in our approaches.
- Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity; comfortable in a results-driven, highly accountable environment where you can make an impact.
- Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Relationship Building – Builds productive working relationships across a diverse spectrum of people.
- Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
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.