Associate Director, Drug Product Enabling Technologies

Location
Cambridge, MA, United States
Posted
Nov 20, 2018
Ref
1240453
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Novel gene therapy platform

We are seeking a highly talented and motivated candidate to drive bluebird bio's drug product manufacturing toward commercial readiness. This role reports to bluebird's senior director of drug product manufacturing and will focus on two areas: (1) driving cross-functional efforts to identify, evaluate, develop, and integrate novel manufacturing and analytical technologies into our drug product manufacturing processes and (2) implementing process improvements to achieve requisite scalability, flexibility and efficiency. The successful candidate will leverage deep technical understanding, acute analytical skills, and demonstrated experience managing cross-functional stakeholders and projects to deliver robust technological infrastructure to support highly-scalable cell therapy manufacturing operations.

About the role:
  • Lead a cross-functional team in the evaluation and integration of manufacturing & analytical enabling technologies. Near-term focus will be on identifying solutions for the automation of these operations (for example, cell processing, sample handling, data collection)
  • Assess and deliver impactful changes to the manufacturing and analytical testing process that decreases variability, risk and cost of goods without impacting safety, potency or ongoing clinical supply.
  • Design and implement a comprehensive program of process designs and improvements that are compliant with CMC, regulatory, QA and QC demands, within the allotted timeline, scope and budget.
  • Build and lead an agile team (1-4 FTEs) to design and execute a holistic strategy on manufacturing technologies and operational improvements.
  • Identify opportunities to collaborate with external entities (academic, engineering, etc.) in creative ways to advance bluebird enabling technologies initiatives.
  • Partner with research, process development, manufacturing, and analytical sciences to identify areas of opportunity to introduce enabling technologies.
  • Develop and manage key supplier relationships to enable innovation and cost containment through mutual accountability and trust.
  • Lead development of proposals for leadership meetings to drive strategy and facilitate decision-making.


About you:
  • You have 8+ years of experience in biotech/pharma, preferably in the autologous cell therapy space. An advanced degree in a relevant scientific/engineering discipline preferred.
  • You have experience in pre-clinical development, cGMP manufacturing or similar areas supporting clinical / commercial technical operations.
  • Your experience spans internal and external technical project leadership with a demonstrated ability to influence both peers and senior leadership to deliver highly cross-functional development projects.
  • You have a deep interest in and working knowledge of technologies relevant to autologous cell production to enable integration of strategies around manufacturing data systems, cell processing, and analytical testing.
  • You are experienced with working in a matrix environment and managing interactions between internal team members and with external partners.
  • You excel at relationship building.
  • You possess strong verbal and written communication as well as active listening skills.
  • You are highly self-motivated, detail-oriented, with demonstrated ability to work independently to effectively manage competing priorities in an extremely fast-paced environment.
  • Previous management experience is required, with demonstrated focus on mentoring and developing members of a team.
  • 10 to 20% travel may be required
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself