**Scientist II, Product Development** **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 Scientist II, Product Development contributes significantly to the successful timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying out required formulation and process activities. The Scientist II, Product Development supports new product development over the lifecycle of the project which could include benchtop/labscale, demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches. 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** + Executes experimental studies intended to provide supporting data or to resolve technical issues encountered during each project. Defines technical objectives and conveys them to other members of the project team. + May represent the Softgel Product Development department at both internal team meetings and customer meetings relating to assigned projects that may be of diverse scope + Coordinates with Analytical Services, Operations, QC, QA, and other groups to ensure project requirements are met. + Resolves technical issues, makes recommendations for options that would resolve the issue, including a preferred option. + Works independently, supervised on a daily or weekly basis, recognizes key issues likely to affect successful and/or timely completion. For those issues that cannot be resolved, brings them to the attention of the person coordinating the work. + Schedules work in order to ensure timely completion of the required activities. + Proposes and implements recommendations to processes and procedures designed to increase efficiency, safety or quality. + Understands revenue associated with each project phase. Flexible with respect to project priorities and ensures that site and/or departmental business objectives are met. + Complete technical activities, development reports and regulatory support documentation + Maintains an awareness of current scientific practice that may have a relevance to Catalent Pharma Solutions. + When requested, provides other support as required. + Complies with Health, Safety and Environmental responsibilities for the position. + Maintains current training records for required procedures. + Assist in training, development, and evaluation of any Softgel personnel when required. + Complies with departmental and company policies + Other duties as assigned. **The Candidate** + BS in scientific field with 7 plus years’ experience in lab, 3 in GMP or + MS in scientific field with 5 plus years’ experience in GMP lab + Doctorate in scientific field with 3 plus years’ experience in lab **Knowledge/Skills Requirements:** + Working knowledge and application of scientific principles and techniques. Exposure to computer software associated with word processing and spreadsheets required with some exposure to statistical software preferred. + Familiarity with batch processing in a pharmaceutical, cGMP environment + Strong knowledge of cGMP Regulatory requirements for process development, technical transfer, and process changes required + Familiarity with ISPE and ICH guidelines preferred + Design, plan, and execute experiments based upon scientific methods for problem solving and process development purposes preferred + Effective communication, documentation and writing skills required + Basic to advanced statistical analysis and calculations preferred required + Attention to detail and high-level of organizational skills required + Basic project management skills (deliverables, timelines, resources required) is preferred + Basic to advanced encapsulation/softgel manufacturing troubleshooting skills required + Knowledge of equipment and tooling selection and design based on process and cleaning requirements required + Familiarity with cleaning cycle development and design including evaluation of detergents, test methods, and calculation of residual limits preferred + Familiarity with root cause analysis and risk assessment techniques (e.g. FMEA) is preferred **Physical/Mental Requirements:** + Mathematical and reasoning ability + Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. + Ability to work effectively under pressure to meet deadlines. 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 laboratory and pilot plant area(s) and office staff and to use required office equipment. + Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles. + Frequent use of a computer monitor. **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 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .