• Senior Director, Clinical Operations

    Catalent Pharma Solutions (Harmans, MD)


    Title: Senior Director, Clinical Operations

    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 strategies to meet contract objectives and achieve business goals. Communicate departmental progress and results effectively through regular governance processes.

    + Forecast and plan clinical activities and resource requirements, including developing and maintaining rolling 12-month forecasts that achieve growth plans.

    The Candidate:

    + B.S. in Engineering or Science discipline and 12+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 10+ years of GMP biologic manufacturing experience. Some or all of this experience should be in either upstream or downstream processing.

    + Manufacturing experience includes mammalian or microbial cell culture and scale-up, the isolation and purification of proteins, antibodies, etc., extensive experience with chromatography equipment, columns, TFF, CIP procedures, and those processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity).

    + Must have experience in a CDMO or CMO environment and must have significant clinical manufacturing experience

    + Minimum of 6 years of leadership experience required

    + Experience with P&L desired

    + Experience with forecasting, project management required

    + Customer facing experience required

     

    The anticipated salary range for this position in Maryland is $280k - $320k plus variable incentive compensation. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

    Why You Should Join Catalent:

    + 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.

    + Dynamic, fast-paced work environment.

    + 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.

    **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

     

    personal initiative. dynamic pace. meaningful work.

     

    Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

     

    Catalent is an Equal Opportunity Employer, including disability and veterans.

     

    If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

     

    Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

     

    Important Security Notice to U.S. Job Seekers:

     

    Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

     

    California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .