Manager, QC Raw Materials (Durham, NC)

Location
Durham, NC, United States
Posted
Sep 24, 2018
Ref
1224227
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, QC Raw Materials to lead the QC Raw Materials function at bluebird bio's new gene therapy manufacturing site in Durham, NC. This includes receipt, inspection, sampling, testing, and retains program for raw materials at the site. In addition, this individual will partner with Corporate QC to ensure the raw materials program complies with bluebird bio's raw material policies. This role will develop and maintain all documentation with regards to site testing requirements and strategies and serve as a subject matter expert (SME) for the raw materials program at the site and provide technical expertise aligned with current GMPs and current industry practice. The candidate will interface with Corporate Quality Control, Quality Operations, Quality Assurance, Manufacturing, and other cross-functional teams as required.

About the Role:
  • Develop and manage the sites raw material program
  • Develop and manage site raw material retrain program
  • Develop and manage site raw material specifications
  • Ensures timely inspection, testing, and sampling of raw materials
  • Manage and review Contract Test Lab data
  • Partner with Corporate QC to develop raw material qualification program
  • Develop in-house raw material testing capabilities
  • Interface with QA to manage non-conforming materials, supplier issues, and participate in vendor audits
  • Author, review, and/or approve SOPs/policies and technical reports
  • Review and approve raw material investigations and deviations
  • Interface with cross-functions teams service as SME for Raw Materials
  • Participate and/or lead in providing the necessary information for regulatory filings and inspections
  • 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