Principal Engineer, Material Science

Location
Cambridge, MA, United States
Posted
Nov 15, 2018
Ref
1187577
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 Materials Science role is to lead the technical assessment of raw materials and product contact materials to bluebird bio's manufacturing processes across our integrated product platforms and late-stage pipeline. The position will develop and deploy appropriate strategies to assess and mitigate risk that process materials present to product quality and supply throughout process development, technology transfer, process validation, commercial manufacturing and process lifecycle. The Materials Science role will help to build a cross-functional team to develop and implement a comprehensive raw material and process consumable strategy to ensure the robust supply of all components of bluebird bio's novel gene therapy products in a cGMP compliant environment.

About the role:
  • 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;
  • Performs material criticality assessments and works closely with Quality to establish raw material specifications and testing strategies;
  • Participates in material supply criticality assessments and works closely with Supply Chain to evaluate alternative materials and vendors;
  • Establishes and deploys a comprehensive single-use technology strategy throughout the bluebird bio product platforms;
  • Leads the design and execution of Extractables & Leachables risk assessments and studies;
  • Leads the technical assessment of manufacturing deviations with raw material-related contributing factors;
  • Collaborates with external supply chain to provide technical assessment of bill of material changes throughout the supply chain (e.g. supplier change notifications, RM testing changes)
  • Collaborates with global and site functions to identify areas of improvement for yield and robustness and to build organizational capabilities in materials science and materials risk management;
  • Contributes to Triage/Leveling of Deviations and Change Control related to raw material and process/product contact materials;
  • Leads technical impact assessment of Change Controls, corrective and preventative actions and manufacturing deviations related to raw material and process/product contact material
  • Identifies areas for incremental process yield and robustness improvements for late-stage and commercial programs;
  • Leads technical CMC input for regulatory interactions related to control of materials;
  • Contributes to establishing industry-wide best practices for cell and gene therapy.


About you:
  • MS/PhD degree in chemistry, biochemistry or chemical engineering field with focus in materials science.
  • 12+/8+ years' experience in biopharmaceutical late-stage development and/or manufacturing;
  • Demonstrated success in delivering process improvements through a raw material or process consumable strategy
  • Direct experience with leading in a matrix organizational structure;
  • Strong writing, editing and presentation skills required
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail-oriented and good problem-solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions.
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself