Bristol Myers Squibb Senior Engineer, Manufacturing Support: Cell Banking Facility in Devens, Massachusetts

Reporting to the Manager, Manufacturing Support Devens Clinical Manufacturing, the Engineer, Manufacturing Support is responsible for providing technical oversight for the cell banking facility. The successful candidate will serve as a process technical lead and Subject Matter Expert for Upstream operations in the cell banking facility and lead the tech transfer into the facility. In addition to this, the successful candidate will provide support for technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing. The individual will be a key contributor to a dynamic and highly technical team of engineers by setting appropriate objectives and priorities, overcoming obstacles, and delivering results within project timelines and will build and maintain effective collaborations with all site support teams. This position is Monday through Friday, first shift, but requires on-call availability in support of coverage for 24/7 manufacturing operation.

Summary:

Reporting to the Manager, Manufacturing Support Devens Clinical Manufacturing, the Engineer, Manufacturing Support is responsible for providing technical oversight for the cell banking facility. The successful candidate will serve as a process technical lead and Subject Matter Expert for Upstream operations in the cell banking facility and lead the tech transfer into the facility. In addition to this, the successful candidate will provide support for technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing. The individual will be a key contributor to a dynamic and highly technical team of engineers by setting appropriate objectives and priorities, overcoming obstacles, and delivering results within project timelines and will build and maintain effective collaborations with all site support teams. This position is Monday through Friday, first shift, but requires on-call availability in support of coverage for 24/7 manufacturing operation.

Key responsibilities:

  • Leads tech transfer and provides technical oversight of the manufacturing process in the cell banking facility

  • Responsible for interacting with cross functional teams to forecast and procure required raw materials.

  • Provides coordination of receiving the vials into the facility.

  • Interacts with QC to coordinate requires testing of the cell banks.

  • Manages the re-qualification requirements for cell banks.

  • Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls

  • Supports the technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing.

  • Oversees and authors facility fit reports and schedule adherence to each aspect of the tech transfer.

  • Support of health authority and internal audits

  • Identifies and assists in the implementation of new technologies from Development into Operations.

  • Leads continuous improvement projects

  • Responsible for process and equipment change controls.

  • Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements

  • Provides technical input for SOP’s required for manufacturing.

  • Provides required technical guidance and approval for manufacturing batch records.

  • Compiles data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary.

  • Reviews and approves single-use consumable drawings required for the manufacturing facility.

  • Actively participates in an environment which fosters safety, quality and continuous improvement in cost and customer service.

  • Support Maintenance activities, including review and approval of Preventative maintenance (PM), drawing updates, and support of out of Specification investigations related to Calibration of critical equipment.

  • Support future capital projects from start to finish, including defining user requirements, supporting installation, commissioning, and Validation activities ensuring equipment functions to current User requirement specifications.

Qualification:

  • B.S. in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 10 years relevant experience in the biopharmaceutical industry., or its equivalent.

  • M.S., in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 8 years relevant experience in the biopharmaceutical industry., or its equivalent.

  • PH.D., in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 4 years relevant experience in the biopharmaceutical industry., or its equivalent.

  • Mastery of SOPs, cGMPs and the know how to work and manage within a regulatory environment.

  • Proven experience in successful execution and management of process technical transfer.

  • Expertise in mammalian cell culture and upstream processing.

  • Strong Experience in investigating process deviations and developing issue resolving CAPAs.

  • Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties.

  • Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to lead people and multi-disciplinary teams.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.