Principal Scientist/Associate Director, Quality Control
- Cambridge, MA
Principal Scientist/Associate Director, Quality Control
Requisition Number: QA20-904
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.
The QC principal scientist role will have a vital role in building Blueprint’s quality control organization. Reporting to the Director of QC, this role will lead all QC aspects of one of Blueprint’s development programs as well as play a supporting role for Blueprint’s commercial programs. This individual is a seasoned QC expert with extensive experience in the management of external QC programs. Experience in transition from development to commercial is essential and this role will support commercialization activities internally and externally. This individual will apply his/her expertise collaborating with CMC cross functionally to support specification and expiry setting, vendor management, and data integrity to support Blueprint’s portfolio of development and commercial programs. The ideal candidate has more than 15 years in QC roles of continually advancing responsibility and specific experience in both API and drug product (small molecule).
Further responsibilities, though not exhaustive, are provided below:
- Support the implementation and optimization of GMP 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 and commercial supply.
- Support / lead data integrity review and implementation of best practices for Blueprint oversight of external laboratories’ data.
- Continual monitoring of method performance (through control charting, trend analysis) and support continuous improvement activities at external labs to minimize investigation occurrence.
- Lead complex OOS/OOT investigations by serving as SME and working closely with external laboratories to identify appropriate CAPAs and monitor effectiveness checks.
- Able to communicate to external laboratories clearly and effectively to influence decisions that aim to continually improve and build Blueprint’s relationship with our partners.
- Set shelf-life for drug substance and drug product by utilizing statistical analysis, when appropriate.
- Ensure successful technical transfer, method validation and routine GMP testing in collaboration with Analytical Development and external QC test labs.
- Ensure all GMP testing is conducted in accordance with SOPs, compendia, approved methods, and in accordance with the company’s and regulatory agencies’ policies and procedures.
- Support the development and enhancement of QC systems, processes, SOPs, and policies (e.g. stability data management, Certificate of Analysis/data review, and reference standard policy).
- Work independently to review and trend QC data, generating stability and other trending reports as necessary.
- Participate in regulatory agency inspections, and assists in observational resolutions, as needed, and prepare appropriate sections of regulatory filings (e.g. IND/IMPD/NDA/MAA) and responses to filing inquiries.
- A Bachelor’s Degree in Chemistry, Biochemistry or a related discipline with at least 15 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%
- 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 qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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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