Manufacturing Associate - North Carolina

Location
Durham, NC, United States
Posted
Oct 12, 2018
Ref
967158
Required Education
Bachelors Degree
Position Type
Full time
bluebird bio at Research Triangle - Manufacturing Associate

Join bluebird bio's enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches. bluebird bio seeks a patient-focused leader as an Manufacturing Associate for our new facility in North Carolina's Research Triangle. You will have responsibilities for executing all process steps in the manufacture of lentiviral vector (LVV), a critical starting material in our gene therapy platform. This role will focus on both the facility startup, new product technology transfers and routine (clinical and commercial) manufacturing. As part of new facility design, construction, startup, and transition to routine operations, this individual will work with the cross-functional bluebird team, including Quality Assurance, Quality Control, Facilities, Manufacturing Sciences & Technology, and Process Development to lead day-to-day operations. We seek candidates with proven ability to work in a GMP environment. Specifically, we are looking for team members with track records of building a safety culture, driving the highest standards of a quality mindset, and ensuring uninterrupted supply for patients. As the facility transitions from a capital project to routine manufacturing, the role will be at the center of implementing a cross-functional management system, focusing on identifying KPIs, tracking their performance on a daily basis, and rapidly taking action based upon that performance.

About the role:
  • Through meaningful career development planning, challenging assignments, and ongoing coaching, invest in creating the next generation of leaders at bluebird bio.
  • Establish systems and oversee operations related to GMP vector manufacturing at the site. The scope of manufacturing includes upstream or downstream operations.
  • SAFETY: In compliance with all state and local requirements, identify potential safety hazards and rapidly implement effective actions; Drive a zero-injury mindset on the team
  • QUALITY: Embed the highest standards of compliance with our quality systems into the site's day-to-day activities; author/update procedures to ensure that activities can be executed Right First Time; strictly comply with all written procedures
  • SUPPLY: Follow daily shift schedules and execute all aspects of the process from media/buffer preparation, vial thaw, cell culture, purification, and final aseptic filling.
  • STRATEGY and COST: Successfully execute technology transfers consistent with bluebird bio's overall manufacturing strategy and achieve continuous process improvement through waste reduction and error proofing.

About you:
  • BS in a scientific discipline with 2-15 years of industry experience.
  • Must be skilled at and committed to the development of other team members
  • Hands-on experience in biologics manufacturing is a must, and experience with viral processing is a plus
  • Strong understanding of operational discipline and cGMPs
  • Experience with new facility startups and process technology transfers is preferred.

Should have excellent organizational skills and be able to multitask in a fast-paced environment with changing priorities.
  • This role will be a day-shift position during start-up. However, you must be willing to have a flexible schedule to support 24x7 manufacturing activities. Travel is expected to be
  • Excellent communication 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