Sr Principal Scientist, Cell Culture

Location
Cambridge, MA, United States
Posted
Oct 23, 2018
Ref
1224172
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Lead technical initiatives to deliver scalable, robust manufacturing processes for stem cell and T cell therapies, including development of integrated control strategies and implementation of technologies to drive continued innovation

Join bluebird bio's enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approach. The Process and Analytical Development organization at bluebird bio encompasses lentiviral vector, gene editing, and cellular drug product processing for oncology and severe genetic diseases. In this role you will have a technical leadership position within the Process and Analytical Development organization, reporting to the Vice President of Process and Analytical Development. The position is ideally suited for a professional with passion for and a proven track record of excellence in cell culture process development. There is great opportunity to leverage cell culture expertise such as media development, 'omics, advanced process control, continuous processing, etc. to lead and evolve our processes and technologies to support a broad oncology portfolio and advance the manufacturing capabilities to scale-out engineered T cell processes. The position is a Director-level matrix leadership role; the successful candidate will work closely with functional leaders and organizations within Pharmaceutical Sciences to achieve goals.

About the role:
  • Develop a vision for industry-leading scientific standards in autologous cell culture for engineered T cell and stem cell therapies
  • Apply biologics development and continuous/automated manufacturing concepts, tools, and practices while driving to re-define how they are applied in this novel and growing field
  • Identify and bring in new technology to improve the process understanding and robustness of autologous cell culture processes
  • Apply Quality by Design principles to develop a deep understanding of the autologous cellular drug product manufacturing process and to define robust, integrated control strategies
  • Identify risks and drive continuous process improvement through technological innovation and alignment with regulatory and commercial manufacturing requirements

About you:
  • A PhD in the pertinent life sciences or engineering, with 10+ years relevant industry experience (or MS with 12+ years) focused on mammalian cell culture process development is required
  • Demonstrated experience leading a diverse technical organization as well as interfacing with external manufacturing providers, partners, and or academic collaborations is required
  • Proven track-record of successfully integrating activities and perspectives across functions is required
  • Must have track record of successfully supporting biologics programs through early or late-stage clinical development.
  • Experience managing scientists and engineers in a research, process development or manufacturing organization is necessary
  • Demonstrated ability to drive technological innovation and implementation in a clinical or commercial manufacturing environment is required
  • Prior experience in the gene therapy field is a plus
  • 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.