Manager, Vector Analytics

Location
Cambridge, MA, United States
Posted
Jul 26, 2018
Ref
967287
Hotbed
Genetown
Required Education
Associate 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/associate manager to oversee an established testing laboratory which supports process development and process characterization testing for multiple stages of our gene therapy and immune oncology products. This includes managing, developing, and/or supporting testing of samples, coordinating testing and data review/trending and managing a small group of associate scientists in their day to day activities. The candidate will interface with multiple process development groups as well as the assay development group and the method validation and tech transfer groups. A strong operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role, as well as experience managing and mentoring.

About the Role:
  • Develop and mentor a team of associate and senior associate scientists in their day to day activities
  • Oversee the testing and reporting of results from assays run internally and externally to various stakeholders
  • Coordinate method transfers from Vector Analytics group to other internal and external labs; provide ongoing support for methods after transfers
  • Author, review, and/or approve test methods, SOPs and technical protocols and reports ; implement and oversee control tracking
  • Implement and manage instrument maintenance/calibration, sample handling and tracking, data integrity and control
  • Participate and/or lead in providing the necessary information for regulatory filings and inspections.
  • Provide representation for Vector Analytics on CMC teams

About You:
  • BS or MS in a scientific discipline, 10+ years of related experience in an analytical/quality operations role is required
  • Must have demonstrated experience (2+ years) of direct supervision of associate scientists
  • Experience in (or comprehensive understanding of) a wide range of molecular biology assays, including cell based bioassays, qPCR, ELISA, and HCP
  • Experience in method transfer and/or method qualification a plus
  • Experience with document management systems
  • Demonstrate a strong initiative and scientific leadership
  • Some knowledge of 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 can 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