Senior Scientist, Analytical Research & Development

Catalent Pharma Solutions • St. Petersburg, FL

11d • Onsite

About The Position

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.

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.
• 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: Senior