Manager, Manufacturing Support

Reporting to the Associate Director, Manufacturing Support Devens Clinical Manufacturing, Manager, Manufacturing Support is responsible for managing a team that provides technical leadership associated with the transfer and manufacture of drug substance designated for clinical/launch. The successful candidate will serve as a process technical lead and subject matter expert for Upstream and Downstream operations. The successful candidate will lead a dynamic and highly technical team of engineers by setting 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 the technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing.
Acts as department lead during absence of Associate Director.
Manages team in the Manufacturing Support group responsible for tech transfer and technical oversight of the process.
Works with crossfunctional teams to develop and drive strategic site initiatives
Develops direct reports
Oversees and authors facility fit reports and schedule adherence to each aspect of the tech transfers.
Provides direct interface as subject matter expert with health authority and internal audits.
Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls
Responsible for interacting with crossfunctional teams to forecast and procure required raw materials.
Leads cross functional risk assessments
Leads continuous improvement projects
Identifies and assists in the implementation of new technologies from Development into Operations.
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 required technical guidance 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.
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.
A minimum of 4 years management experience leading a team is highly desired.
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.
Experience in the design, control and operation of biologics upstream and downstream unit operations.
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.

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