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Product Development 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.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.

The **Product Development Manager** is responsible for ensuring the efficient, timely execution of R&D activities in the Laboratory and Operations. This includes the coordination of staffing, the timely procurement of raw materials, supplies and equipment as well as the establishment of processes and procedures to ensure the successful completion of R&D activities within the required project timelines. The **Product Development Manager** will be providing leadership, managing assigned personnel, ensuring organizational alignment, implementing and improving processes and procedures, ensuring safety and cGMP compliance, and providing training to the scientific team.

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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Role

+ Provide strategic technical expertise and guidance to the formulation team to enhance the development of robust, innovative, and scalable formulations, ensuring alignment with regulatory requirements, quality standards, and project timelines to achieve successful product development and commercialization.

+ Develops and sustains customer relationships through direct interaction, responsiveness and accountability.

+ Interfaces with internal and external customers on the Operations requirements for their products and process improvements.

+ Develop and maintain a strategic lab planning process to support resource and finite scheduling of the Development group to achieve Product Development performance goals.

+ Ensure clear visibility of milestone completion dates and confirm that resources (personnel, equipment, and supplies) are adequate to meet project requirements.

+ Provide leadership and day-to-day management of quality, safety, and compliance activities.

+ Guide and coach scientific personnel in formulation development, robust process design, and writing batch documentation based on a Quality by Design (QBD) approach.

+ Other duties as assigned.

The Candidate

+ PhD/MS in Analytical Chemistry, Chemistry, Pharmaceutics or related science with 5+ years relevant pharmaceutical analytical development experience required OR

+ BS in a related science with 10+ years pharmaceutical development experience required, preferably with FDA-regulated products (Rx, generic and consumer health) and 4+ years of managerial experience. Contract development experience preferable.

+ Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently

+ Flexibility required to work outside normal working hours of 8:00 a.m. – 5:00 p.m.

Why you should join Catalent:

+ Tuition Reimbursement – Let us help you finish your degree or earn a new one!

+ WellHub program to promote overall physical wellness.

+ 152 hours of PTO + 8 paid holidays.

+ Medical, dental and vision benefits effective day one of employment.

+ Defined career path and annual performance review and feedback process.

+ Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

+ 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.

+ 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 (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) .