Senior Scientist, Analytical Research & Development

Catalent Pharma Solutions • St. Petersburg, FL

1d • Onsite

About The Position

Senior Scientist, Analytical Research & Development Position Summary Work Schedule: Standard Hours; Monday through Friday 100% on-site Join Catalent’s flagship softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility. The Senior Scientist, Analytical Research & Development supports the development and validation of analytical test methods, raw material evaluation, and testing of non-commercial materials to advance product development, manufacturing, process validation, and new material qualifications in accordance with regulatory and quality standards. At Catalent, this role offers exceptional exposure to a diverse portfolio of molecules formulated into the softgel platform — spanning women’s health, oncology, prescription therapeutics, and more — providing hands-on experience from development through commercial validation. As part of a CDMO environment, the position delivers broad cross-functional collaboration and the opportunity to build advanced analytical skill sets. The Role Independently develop, validate, and routinely execute instrumental test methods in support of Drug Substances and Drug Products; analyze data, document results in accordance with cGMP and internal guidelines, and communicate findings through written and oral presentations. Serve as lead scientist for designated projects, including direct client communications, participation in project team meetings and teleconferences, and support of new product development in collaboration with customers and suppliers. Perform analysis of finished products, in-process materials, raw materials, fill moisture, cleaning verification/validation samples, and support the Material Evaluation Process for new materials according to assigned specifications, methods, and protocols. Write, review, and support analytical methods, deviations, protocols, specifications, SOPs, and laboratory investigations using appropriate Root Cause Analysis tools; lead analytical method transfer activities as required. Ensure right-first-time execution of departmental methods and SOPs; audit and verify analytical results for accuracy and data integrity; maintain proper records in notebooks, reports, and logbooks in compliance with FDA, EPA, OSHA, and company regulations. Safely handle potent and teratogenic compounds; prepare reagents, standards, and media; manage hazardous waste disposal; support ordering and maintenance of laboratory materials and equipment. Contribute to continuous improvement by training colleagues, leading and coordinating personnel training, participating in inter-departmental teams, interfacing with management, self-scheduling assignments, and working flexible hours as required to support production and validation schedules. Other duties as assigned.

Requirements

• Doctorate in scientific field with 3-years’ experience in lab, 2 in GMP required OR Master’s in scientific field with 5+yrs experience in lab, 3 in GMP required OR Bachelor’s in scientific field with 10-yrs experience in lab, 8 in GMP required
• Minimum of 5 years’ experience with identification or separation techniques such as HPLC, UPLC, GC, MS, NMR and experience with method development and or validation.
• VISION: Ability to read written documents and computer monitors, differentiate color, and maintain 20/30 vision with or without corrective lenses; able to work extended or off-hours as required.
• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.

Responsibilities

• Independently develop, validate, and routinely execute instrumental test methods in support of Drug Substances and Drug Products; analyze data, document results in accordance with cGMP and internal guidelines, and communicate findings through written and oral presentations.
• Serve as lead scientist for designated projects, including direct client communications, participation in project team meetings and teleconferences, and support of new product development in collaboration with customers and suppliers.
• Perform analysis of finished products, in-process materials, raw materials, fill moisture, cleaning verification/validation samples, and support the Material Evaluation Process for new materials according to assigned specifications, methods, and protocols.
• Write, review, and support analytical methods, deviations, protocols, specifications, SOPs, and laboratory investigations using appropriate Root Cause Analysis tools; lead analytical method transfer activities as required.
• Ensure right-first-time execution of departmental methods and SOPs; audit and verify analytical results for accuracy and data integrity; maintain proper records in notebooks, reports, and logbooks in compliance with FDA, EPA, OSHA, and company regulations.
• Safely handle potent and teratogenic compounds; prepare reagents, standards, and media; manage hazardous waste disposal; support ordering and maintenance of laboratory materials and equipment.
• Contribute to continuous improvement by training colleagues, leading and coordinating personnel training, participating in inter-departmental teams, interfacing with management, self-scheduling assignments, and working flexible hours as required to support production and validation schedules.
• Other duties as assigned.

Benefits

• Tuition reimbursement to support educational goals
• WellHub program to promote physical wellness & Access to Perkspot discounts from over 900 merchants
• 152 hours of PTO plus 8 paid holidays
• Medical, dental, and vision benefits effective day one
• Defined career path with annual performance reviews & strong potential for career growth within a mission-driven organization
• Inclusive culture with active Employee Resource Groups & Community engagement and green initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree