Scientist, Upstream Vector Process Development

Location
Cambridge, MA, United States
Posted
Oct 23, 2018
Ref
871816
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approaches. bluebird bio seeks an experienced professional to join the upstream vector process development group. In this role you will have a position within the process and analytical development organization, specializing in late stage process development responsibilities.

Responsibilities:
  • Authoring CMC sections of regulatory files (MAA, BLA, IND, IMPD, scientific advice), including responses to questions from regulatory agencies
  • Author product impact assessment for deviations and support any subsequent investigations
  • Support and/or lead technology transfer of LVV manufacturing process to internal and external manufacturing sites
  • Work with key stakeholders to develop process monitoring capabilities using statistical process control concepts
  • Support late stage process development activities such as control strategy documents and process characterization activities
  • Build strong relationships across the organization to accomplish cross-functional tasks as well as identify and develop action plan for deficiencies
  • Identify risks and drive continuous improvement through technological innovation and alignment with regulatory and commercial manufacturing requirements

Qualifications
  • A MS in life sciences or engineering, with 5 to 8 years relevant industry/academic experience or BS with 8-10+ years relevant experience
  • Strong knowledge of GMPs, including Deviations, CAPA, and Change control is a must
  • Experience authoring CMC sections of regulatory files is a must
  • Previous experience interfacing with regulatory inspectors is preferred
  • Previous management experience is a plus
  • Familiar with statistical approach to process monitoring is strongly desirable
  • Prior experience in the gene therapy field is a plus but not required
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
  • Outstanding communication, analytical, and organizational skills
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
  • Above all else, an absolute passion for addressing the critical unmet needs of patients.