Sr. Manager, QC Bioassay / Biochemistry - NC

Durham, NC, United States
Aug 08, 2018
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 Bioassay / Biochemistry to build and lead the QC Bioassay and Biochemistry function at bluebird bio's new gene therapy manufacturing site in Durham, NC. This includes providing oversite of routine and non-routine analyses of test samples by qPCR, cell-based potency methods, ELISA, and other analytical methods. This role will partner heavily with internal bluebird QC functions to ensure successful analytical method transfers into the laboratories to support site start-up. This role will develop and maintain all documentation with regards to testing requirements and strategies and serve as a subject matter expert (SME) for the issues and provide technical expertise aligned with current GMPs and current industry practice. The candidate will interface with Quality Control, Quality Assurance, Manufacturing, and other cross-functional teams as required.

About the Role:
  • Lead, manage and develop QC Bioassay / Biochemistry team
  • Ensure lab compliance with applicable cGMP regulations and SOPs
  • Manage QC Bioassay / Biochemistry activities and prioritize work to ensure site timelines are met
  • Author, review, and/or approve SOPs/policies and technical reports
  • Review and approve QC investigations and deviations
  • Interface with cross-functions teams service as SME for bioassay and biochemistry methods
  • 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 Biochemistry, Biology, Microbiology, Chemistry or other related field
  • Minimum 10+ years of related experience within the biopharmaceutical industry with experience in qPCR, ELISAs, and cell culture-based potency assays, experience with method transfer and validation strongly desired
  • 5+ years of supervisory experience
  • Track record of leading QC testing in a Commercial FDA/EMA approved lab
  • 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