Associate Manager, Cellular Therapy Manufacturing Operations

Location
Cambridge, MA, United States
Posted
Oct 11, 2018
Ref
967219
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

This Manufacturing Operations Associate Manager will support the organization by providing manufacturing operations and technical oversight for early to late stage clinical study material production. In this position, you will spend the majority of 2019 embedded full-time at our contract manufacturer based in New Jersey as the bluebird manufacturing representative. At the end of 2019, this role will transition from person-in-plant to being full-time at bluebird bio's Cambridge, MA headquarters. You will oversee planning, manufacture, disposition, and excursion management. Through collection and trending of data, you will help build process understanding and identify process improvements where needed. This position requires a strong understanding of cellular processing and GMP operations, and a prominent ability to handle soft-skills situations with tact and finesse.

About the role:
  • Be the primary point of contact with contract manufacturing organizations (CMOs) and manage day-to-day operations
  • Provide technical support of GMP manufacturing runs for ongoing clinical studies carried out by CMOs
  • Serve as person-in-plant for on-going clinical manufacturing, as well as process engineering and/or training runs
  • Work closely with Quality Assurance and CMOs as applicable for successful resolution of deviations, CAPAs, Change Controls, etc.
  • Review, collect and trend data from manufacturing batches to help identify trends, assess performance, build process understanding, and enable improvement activities.
  • Manage timelines and deliverables for technology transfer to CMOs including raw material and equipment procurement
  • Work closely with internal stakeholders to map out and execute process improvement activities to drive alignment, simplification and cost reduction
  • Work with and develop training curricula and module content for CMO personnel; conduct onsite or offsite training on manufacturing processes
  • Own and drive to conclusion change controls associated with improvements across numerous processes
  • Participate in internal technology transfer activities, planning meetings and interact effectively with cross functional departments
  • Up to 10-30% travel with frequent weekend work

About you:
  • BS/MS with 5 - 7 years of experience in pre-clinical development, or cGMP manufacturing of clinical and/or commercial programs, with experience in cellular and gene therapies a significant plus
  • Experience working with CMOs, and experience conducting tech transfers highly desirable
  • Good understanding of applicable regulations and standards (e.g., GMP, and AABB)
  • Prior cGMP manufacturing experience for clinical-stage cell or gene therapies is highly favorable
  • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
  • Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
  • Independently motivated, detail oriented and good problem-solving ability
  • Proficient with timeline development and project tracking using MS Project is a plus
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself


bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE.We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a fast growing company provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio, 60 Binney Street, Cambridge, MA 02142 www.bluebirdbio.com

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.