Clinical Supply Program Manager
Position Summary:
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.
This is a full-time salaried position: Monday – Friday, 1st shift.
Demand Led and Decentralised Trial Supply are two of the most exciting clinical trial supply innovations in recent times. Catalent is at the forefront of both advancements within the industry, and the Clinical Supply Program Manager is central to our continued success.
The Clinical Supply Program Manager will be a key member of the Strategic Supply Solutions team, scoping, planning and leading the continued development of these initiatives. You will have significant input in continuous improvement, designing processes, contributing to SOP preparation and technology solutions.
The Clinical Supply Program Manager has overall responsibility and accountability for providing Global Leadership and proactive Client Relationship management to a client or group of clients as appropriate ensuring appropriate communication, business engagement, implementation and service delivery to enable retention, growth and long term mutual business partnership. This will be achieved through leading global teams comprised of Global Project Managers and Project Managers across Demand-Led and Direct To Patient trials.
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.
The Role:
Work with Director and other SMEs to gain a thorough understanding of Decentralized Trials, Direct to Patient shipping requirements, Site to Patient, DCT technologies, and industry trends; become an SME capable of training others, while staying current with trends and customer needs
Work with Director to manage DCT activities for new opportunities to achieve sales and new business goals from identification through contract award
Work with Project Managers to set up projects for success and act as point of escalation for all DTP and DCT related activities once in execution mode. Provide project oversight and solutioning, as needed
Work with Director to expand DTP and DCT services in Europe and ROW - audits of partners, process mapping and SOP creation. Train internal teams on capabilities and process
Work with PM and BD to respond to customer inquiries and requests for information from both internal and external customers in a timely manner
Lead the identification, development, implementation and control of Continuous Improvement activities required by the Program
Develop, maintain and train Global SOPs relating to DLS Program and Project Management
25% travel expectations (global)
Other duties as assigned
The Candidate:
Bachelor's degree in Science or related discipline with 2+ years of relevant experience, preferred
High school diploma or equivalent with 8+ years of relevant experience, required
Pharmaceutical experience, required
In depth understanding of clinical trials and other business services
Thorough knowledge of GMP
Good knowledge of drug development process and GCP requirements in clinical development
Proficiency with MS Office Programs, including MS Project, WorkFront
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
Why You Should Join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
WellHub - program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.