Manager - Manufacturing Sciences & Technology, Operational Engineering

Catalent - Madison, WI

Full-time - Manager

Madison, WI

Chemical Manufacturing

About the position

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market-leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's. 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. The MS&T organization supports the Madison facility as well as the Catalent Biologic's network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement. The team is broken down into three key subgroups: MS&T, Upstream Technology Transfer; MS&T, Downstream Technology Transfer; MS&T, Operational Engineering; and MS&T, Technical Writing. The Operational Engineering group primary function is to provide technical support for the manufacturing execution team. This includes on the floor or on-call support during execution. The team will be the subject matter experts on the manufacturing process and equipment and provide input in the design of consumables and batch records/SOPs to support operational success. This is a full-time on-site position, Monday - Friday 8:00am-5:00pm. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

Responsibilities

• Lead a team in technical support of Manufacturing, including on the floor support and technical improvements for equipment and processes.
• Lead a group of engineers, scientists, and other colleagues to provide technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.
• Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
• Support technology transfer of processes into manufacturing for both internally and externally developed processes.
• 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.
• Participate in and support strategic alignment across Catalent Biologics sites and the Madison site.
• 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.
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
• Responsible for maintaining a high-performing team by hiring, training, motivating, evaluating, and developing staff (direct reports and others).
• Other duties as assigned.

Requirements

• Bachelor's degree in a STEM discipline and 9+ years related experience, OR
• Master's degree in a STEM discipline and 7+ years related experience, OR
• Doctorate Degree in a STEM discipline and 4+ years related experience.
• Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally required.
• Minimum of 3 years' experience in a people leadership role preferred.
• Ability to work with and lead other groups to develop, qualify, and transfer methods and drive complete investigation, deviation, and change control practices.
• Strong technical knowledge and hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.
• Influential leader/SME of Upstream (mammalian cell culture) or Downstream (e.g., depth filtration/clarification, chromatography, tangential flow filtration, viral filtration, BDS fill, etc.) manufacturing processes across cGMP biologics production scales.
• Experience in facility fit, process scaling, and technology transfer required.
• Experience in equipment engineering and process improvements.
• Excellent written and verbal communication skills with internal and external customers.
• Experience with operating and troubleshooting process equipment, including single-use systems and consumables.
• Experience working on late phase, process performance qualification, and commercial programs is a plus.

Nice-to-haves

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement