Manager - Manufacturing Sciences & Technology

About the role

The Manager will be responsible for the drafting and review of documentation, compilation, and assessment of applicable data, change management, utilization, and monitoring while providing technical input for risk assessments, gap analysis, deviation investigations, change controls, root-cause analysis, CAPAs, and determination of product or process impact. This position will be client-facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward. Use comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead complex projects within a department, group, or team in a single function or focus. Apply technical and functional knowledge to design experiments/projects that contribute to overall direction of department/discipline. Lead a group of 5 to 12 direct reports (Engineers, Scientists, Group Leaders, etc.) in technical support of Manufacturing to drive the facility fit and technical transfer of mammalian biologic processes. Maintain a high performing team by hiring, training, motivating, evaluating, and developing staff. Support technology transfer of processes into manufacturing for both internally and externally developed processes. Responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements. Manage strategic or continuous improvement activities across the teams within the department or across multiple departments within the site. Coordinate with teams in other departments and across business units. Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility. Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing. Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations. Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market. Support the building of business case(s) for process improvement projects. Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports. Other duties as assigned. The Candidate: Bachelor's degree in STEM discipline is required plus a minimum of 9 years of relevant experience defined as: upstream tech transfer, mammalian cell culture, fermentation, leadership, plus hands-on experience with troubleshooting process equipment in a GMP setting - ideally in a CDMO or client-facing environment. We will also accept a Master's degree with 7+ years OR a Doctorate degree with 4+ years of relevant experience. Strong systems knowledge is required, including Microsoft Office, TrackWise or similar QMS, ComplianceWire, Unicorn, DeltaV. Must be a subject matter expert and technical leader in upstream (mammalian cell culture) or downstream (e.g., clarification, chromatography, tangential flow filtration, viral filtration, bulk drug substance fill) manufacturing processes, supporting cGMP biologics production across clinical to commercial scales. Technical Requirement: Demonstrat

Additional Information

Manager - Manufacturing Sciences & Technology (Upstream Technology Transfer) Position Summary: Work Schedule: Monday - Friday, core hours 8am-5pm 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics. The Manager for Manufacturing Sciences & Technology will be a key leader for the Upstream Tech Transfer group. The Upstream and Downstream Technical Transfer groups are the technical liaisons between Process Development (internal or external) and at-scale GMP manufacturing relating to process transfer. This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modeling and facility fit including initial bill-of-material development. The Manufacturing Sciences and Technology (MS&T) department's primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, mRNA, new modalities, etc.), equipment, consumables, technical writing, and drug substance lifecycle management.

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