Quality Control Science and Technology Manager

Location
Cambridge, MA, United States
Posted
Nov 07, 2018
Ref
1224202
Discipline
Quality, Quality Control
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. bluebird bio is leading the gene therapy revolution using our gene addition, cell therapy and gene editing platforms to develop potentially transformative products for patients with severe genetic diseases and cancer.

It's personal at bluebird - where our colorful flock of birds is united by a singular focus: a passionate commitment to changing the lives of patients. Our science, technology, and our people come together to make a difference.

we are always innovating, never stopping and never giving up.

We seek an experienced Quality professional with extensive experience with method implementation, validation, and lifecycle management. The methods will support a wide variety of manufacturing process technical transfers as well as routine Quality Control operations. The QSAT manager will lead a growing team and should have a proven track record as a supervisor or manager in a fast-paced innovation driven setting. The role will interface with internal Quality Control, Analytical and Process Development, Manufacturing Sciences and Technology, and multiple Quality Assurance groups to ensure company procedures and industry guidelines are followed. A strong technical background, and proven track record in Quality Control, with methods related to viral advanced cell therapies, bioassay, cell biology, biochemistry, and molecular biology. This position will require travel.

About the Role:
  • Collaborate internally and externally to manage a team focused on implementation and lifecycle management of analytical, cell-based, and immunological-based test methods
  • Collaborate internally and externally to manage a team focused on manufacturing process technical transfer, in-process testing strategy, analytical and process comparability assessments
  • Support or lead implementation of a monitoring program focused on analytical method performance, including assessment of analytical method system suitability requirements
  • Experience with statistical data analysis for method and process monitoring and reporting
  • Support of cGMP operations, including technical review of change control documentation and reports, deviations, OOS and other manufacturing and laboratory investigations
  • Lead the review of internal SOPs/policies to align with industry standards related to analytical method and critical reagent lifecycle, including continued process verification for viral-based Advanced therapy medicinal products
  • May manage 2+ direct reports and a team of 4+

About You:
  • BS with 10+ years or MS with 8+ years in a biotechnology discipline
  • 10+ years of experience in a GMP/GxP environment is preferred
  • 3+ years of managing direct reports in an analytical or Quality Control laboratory
  • Supervisory experience, including the management of direct reports, overseeing the execution of release and stability testing in an analytical or Quality Control environment
  • Knowledge of designing analytical method validations in accordance with cGMP/ICH/FDA/EU regulations
  • 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