Senior Director, Clinical Operations

Title: Senior Director, Clinical Operations

Location: Harmans, MD

Position Summary:

Reporting to the site VP GM, the Senior Director of Clinical Operations is a key leadership role at Catalent’s Maryland sites, responsible for driving the strategic direction and operational success of gene therapy clinical operations. This position involves leading a high-performing, cross-functional team to ensure the seamless execution of clinical manufacturing processes, while meeting both client expectations and internal performance goals. The Senior Director will leverage extensive expertise in clinical program delivery, including manufacturing, technical transfer, project management, and supply chain operations, 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 clinical operations team responsible for operations, supply chain, manufacturing support teams (MST), project management (PM), and quality assurance (QA) functions, ensuring "right first time" and "on-time" delivery of client milestones and programs.
• Lead and manage multiple teams across clinical manufacturing campaigns, ensuring continuous and effective 24/7 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. Foster and maintain strong customer relationships, ensuring high client satisfaction and cultivating a "green" client temperature status to promote repeat business.
• Partner with Business Development to ensure new program scopes are optimized for successful execution. Engage with clients during presentations and throughout the clinical manufacturing process, ensuring seamless communication and alignment with client needs, while proactively addressing any issues.
• Oversee upstream (direct line resources) and downstream (dotted line resources) clinical production, including protein production and purification from microbial and cell culture processes, through bulk drug substance and drop product.
• 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 clinical manufacturing procedures and specifications, maintaining regulatory adherence.
• Ensure the successful technical transfer of clinical 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.
• Collaborate with senior management to initiate new clinical production projects, developing stra