Sr. Manager - QC Microbiology

Location
Durham, NC, United States
Posted
Jul 26, 2018
Ref
967215
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 Senior Manager, QC Microbiology to build and lead the QC Microbiology group and bluebird bio's new gene therapy manufacturing site. This includes developing the environmental monitoring and trending program, establishing best practices within the QC Microbiology lab, and providing oversight for the testing of release, stability, and routine EM samples. This role will develop and maintain all documentation with regards to testing requirements and strategies and serve as a subject matter expert (SME) for microbiology and sterility assurance issues and provide technical expertise aligned with current GMPs and current industry practice. The candidate will interface with Quality Operations, Quality Assurance, Manufacturing, Facilities, and other cross-functional teams as required.

About the Role:
  • Lead, manage and develop QC Microbiology team
  • Manage, develop and maintain the Environmental Monitoring and Utility Monitoring Programs, and prepare quarterly and annual trend reports
  • Accountable for managing the sterility assurance program to ensure quality, product specifications, and adherence to current regulations and bluebird bio standards
  • Manage QC Microbiology activities and prioritize work to ensure site timelines are met
  • Author, review, and/or approve SOPs/policies and technical reports
  • Review and approve QC Microbiology investigations and deviations
  • Interface with cross-functions teams service as SME for Microbiology
  • 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 Microbiology, Biology, or other related field
  • 8+ years of related experience within the biopharmaceutical industry with experience in aseptic processing required, experience in site start-up operations is a plus
  • 3+ years of supervisory experience
  • Track record of leading a QC Microbiological testing lab supporting
  • Demonstrate a strong initiative and scientific leadership
  • Demonstrated knowledge of cGMP/ICH/FDA/EU regulations
  • 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