Senior Director, Commercial Manufacturing Operations

Senior Director of Manufacturing Operations, Commercial

Position Summary:

Reporting to the site VP GM, the Senior Director of Commercial Manufacturing Operations is a key leadership role at Catalent’s Maryland sites, responsible for driving the strategic direction and operational success of gene therapy commercial operations. This position involves leading a high-performing, cross-functional team to ensure the seamless execution of commercial manufacturing processes, while meeting both client expectations and internal performance goals. The Senior Director will leverage extensive expertise in commercial high volume and pace manufacturing to ensure the successful execution of gene therapy programs. This role is pivotal in cultivating strong client relationships, maintaining operational excellence, and working closely with site leadership to advance Catalent’s commitment to delivering high-quality, innovative gene therapy solutions.

With more than 30 years of experience in biologics services and partnerships with more than 20 premier gene therapy companies, Catalent is the trusted gene therapy CDMO partner for custom viral vector development and scalable manufacturing of adeno-associated virus (AAV) vectors, next-generation vaccines, and oncolytic viruses. We have experience with more than 60 gene therapy programs across various stages of development, a commercially approved manufacturing facility, and a total plasmid and gene therapy footprint of 600,000+ square feet. 

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Role

• Direct and lead a commercial manufacturing operations team. Lead and manage multiple teams across commercial manufacturing campaigns, ensuring continuous and effective 24/7 responsible for upstream, downstream, and fill finish functions, ensuring "right first time" and "on-time" delivery of operations.
• Demonstrate strong and effective collaboration across all functional leaders and teams, ensuring alignment of priorities and delivering excellence in operational execution.
• Partner with Human Resources to attract, onboard, develop and retain top talent, ensuring a positive and comprehensive growth experience for all team members.
• Lead by example, promoting and upholding organizational values and goals to inspire the team. Serve as a key member of the site leadership team, with accountability for business results within the Commercial business and the full Baltimore site business.
• Foster and maintain strong customer relationships, ensuring high client satisfaction and cultivating a "green" client temperature status to promote repeat business.
• Engage with clients during collaborative presentations and throughout the commercial manufacturing process, ensuring seamless communication and alignment with client needs, while proactively addressing any issues.
• Oversee end to end manufacturing: upstream, downstream, fill finish commercial production, including protein production and purification from microbial and cell culture processes, through bulk drug substance and drug product.
• Effectively reduce deviations, ensuring CAPA robustness in manufacturing. Appropriate Ensure KPIs and Operating Mechanisms/Reviews are in place (eg. Tier process) to provide necessary focus and escalation on all elements of operational performance
• Troubleshoot and resolve process and equipment issues, ensuring proactive communication with clients and internal stakeholders. Develop, revise, and ensure compliance with commercial manufacturing procedures and specifications, maintaining regulatory & safety standard adherence.
• Ensure the successful technical transfer of commercial manufacturing projects in collaboration with the Tech Transfer team, simplifying processes as programs approach commercialization and eliminating deviations.
• Ensure the implementation of GMP and safety training processes, with an emphasis on cross-training and improving production records.
• Define, execute lean transformation initiatives