As part of the Sanofi Biologics Development organization in Framingham, the Drug Substance Manufacturing Biologics (DSMB) is responsible for the GMP production of cutting-edge biologic drug substance material to support clinical candidate programs. The group is responsible for transferring in and implementing the cell culture/production, purification, and formulation bioprocesses for early stage biotherapeutic clinical product candidates and works closely with the Upstream and Downstream Process Development as well as Biologics Process Engineering groups to understand each of the products that come through the area. DSMB also interacts closely with the Quality Assurance (QA), Bioprocess Engineering, Validation, and other groups to ensure cGMP’s and manufacturing schedules are maintained. Operations’ main functions are the execution of manufacturing campaigns, leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives.
This role is responsible for managing an upstream manufacturing department and ensuring execution of production plan, compliance initiatives, and project/campaign scheduling across multiple shifts.
Provide managerial oversight and subject matter technical expertise (SME) to a group of individuals while also participating in on-the floor activities to ensure adequate execution of manufacturing campaigns in a multi-product GMP facility.
Lead adaptation of new technology into the area as appropriate
Ensure timely issue escalation of issues to manufacturing leadership and cross-functional support team
Lead cross functional teams to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
Maintain and track KPIs for the assigned area
Partner with other senior managers for the following:
- Design departmental training plan and manage execution
- Ensure inspection readiness of assigned manufacturing areas
- Drive/Sponsor improvements and efficiency initiatives
- Identifies opportunities to improve manufacturing process and practices
- Partners with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S, and VSM
Bachelor’s Degree in a Life Sciences or Engineering field such as Chemistry or Biology or related discipline with a minimum of 10 years of experience in a cGMP manufacturing environment or an Associate’s Degree (or equivalent) with 12 years of experience in a cGMP manufacturing environment
Extensive experience with Upstream Bioprocess unit operations/technologies and background
In depth knowledge of biopharmaceutical cGMP manufacturing operations
At least 5 years of experience in managing direct reports or teams
Track record in successfully demonstrating people management skills including ability to develop self, build high performance teams, develop others and maintain accountability.
Excellent communication skills
Ability to influence and build relationships
Track record in successfully managing more than one large, complex manufacturing operation at a time
Experience working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering, and Validation
Experience authoring and reviewing GMP procedures, documents, investigations, change controls.
Experience in troubleshooting, investigation, and root cause and risk analysis in a cGMP environment
Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives.
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