QC Global Raw Materials Manager - Cambridge, MA

Location
Cambridge, MA, United States
Posted
Aug 08, 2018
Ref
1155654
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced Manager to lead the newly created Global Raw Materials function. This individual will be responsible for further developing the global raw materials strategy, harmonizing raw materials requirements and incoming testing approaches across external and internal manufacturing sites, and overseeing vendor material change notification. This role will develop systems and procedures, build relationships with our CMO/CTO network, and serve as a subject matter expert (SME) for raw materials used globally. This role will also help to assess raw materials requirements (compendial and non-compendial) as we move into new global regions (Japan). The candidate will interface with Quality Assurance, Vendor Management, Supply Chain, Manufacturing, Process development and other cross-functional teams as required.

About the Role:
  • Develop and manage global raw materials strategy and policies
  • Harmonize RM programs across CMO, CTO, and internal manufacturing operations
  • Oversee Vendor Change Notification system
  • Participate in Raw Material Risk Assessments as subject matter expert
  • Assess impact of new global regions on Raw Material requirements
  • Partner with internal (North Carolina) raw materials group on process improvement initiatives
  • Partner with Supply Chain, QA, and Manufacturing on vendor selection and qualification
  • Interface with QA to manage supplier issues and participate in vendor audits
  • Author, review, and/or approve SOPs, policies, risk assessments, and technical reports
  • Interface with cross-functions teams service as SME for Raw Materials
  • Contribute to regulatory filings
  • Lead and support CAPA/Continuous Improvement Initiatives


About You:
  • BS or MS in a Chemistry, Biochemistry, Microbiology, Biology, or other related field
  • 5+ years of related experience within the biopharmaceutical industry managing a raw materials program
  • 3+ years of supervisory experience
  • Demonstrate a strong initiative and scientific leadership
  • Demonstrated knowledge of cGMP/ICH/FDA/EU regulations
  • Demonstrated knowledge of USP, EP, and JP monographs
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Superb organizational, analytical, and communications skills and "do-what-it-takes" attitude
  • A passion for addressing the critical unmet medical needs of patients
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself