Senior Associate Process Engineer, Manufacturing Science and Technology

Location
Cambridge, MA, United States
Posted
Nov 09, 2018
Ref
1298791
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 therapy approach. The Manufacturing Science and Technology (MSAT) organization at bluebird bio is a team of scientists and engineers responsible for the technical support and oversight of late stage and commercial manufacturing processes for small molecules, oligonucleotides, lentiviral-based vectors and stem and immune cell-based therapies across internal and external manufacturing sites.

The focus of the Sr. Associate Process Engineer role is to support late-stage and commercial lentiviral vector manufacturing processes through the planning, execution and analysis of at-scale and scale-down experiments to enhance process understanding and performance. The chosen candidate will have the opportunity to participate in the transfer, improvement, and evaluation of manufacturing activities for our rare disease and oncology pipelines. We seek candidates with proven ability to successfully work independently and collaboratively across functions to enhance product quality, quantity, and process efficiency. We are passionate about transforming the lives of patients, incredibly cool science, and bird puns.

About the role:
  • This is a lab-based position with a focus on lentiviral vector manufacturing technology to support investigations and continuous improvement initiatives, including independent planning, execution, and analysis of experiments at manufacturing scale and qualified scale-down model.
  • Authoring and review technical documentation related to internal and external manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
  • Works cross-functionally across Program/CMC Teams, Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide technical assessment for engineering and process changes in a cGMP environment.
  • Proactively identify and propose mitigations to risks as part of continuous improvement in alignment with regulatory and commercial manufacturing requirements.

About you:
  • Master's degree and 1-3 years of directly related experience or bachelor's degree and 3-5 years of directly related experience
  • Degree emphasis in Chemical Engineering, Biochemistry, Bioengineering, Molecular Biology, or related field preferred
  • A successful candidate will possess excellent communication skills, including writing and oral presentation, and the flexibility to move between the planning and execution of each required function, as needed
  • General knowledge of process development and pharmaceutical manufacturing for biologics including upstream and downstream unit operations
  • Demonstrated aseptic technique with adherent mammalian systems
  • Experience with quality systems including Deviations, CAPA, and Change control is preferred
  • Prior experience in the gene therapy field is a plus, but not required
  • Track record of completing deliverables within specified timelines
  • Self-motivated with a "do-what-it-takes" approach to problem solving
  • 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/values: b colorful, b cooperative, and b yourself
  • Above all else, an absolute passion for addressing the critical unmet needs of patients