Senior Scientist, Analytical Research & Development

Catalent Pharma Solutions LLC; Saint Petersburg (FL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Tuition reimbursement

WellHub program

Perkspot discounts

PTO + holidays

Day one benefits

Career growth opportunities

Job summary

Catalent, Inc. in St. Petersburg, FL, is seeking a Senior Scientist in Analytical Research & Development to advance analytical test methods and validate materials for drug development in a state-of-the-art CDMO environment.

You will independently develop and transfer analytical methods, analyze data, and communicate findings to clients and internal teams, supporting development through validation and materials qualification with compliance to cGMP and regulatory standards.

Qualifications

• Doctorate or Master's with GMP experience required, extensive lab experience.
• Experience with identification or separation techniques and method development/validation.
• Strong data analysis and regulatory/compliance knowledge (cGMP, FDA).

Responsibilities

• Develop and validate analytical test methods for Drug Substances/Products.
• Lead method transfer activities and client communications.
• Analyze data, document results, and ensure data integrity per guidelines.
• Support material evaluation, process validation, and new material qualifications.

Skills

HPLC

UPLC

GC

MS

NMR

Education

Doctorate in scientific field

Master's in scientific field

Bachelor's in scientific field

Job description

Position Summary

Senior Scientist, Analytical Research & Development Position Summary Work Schedule: Standard Hours; Monday through Friday 100% on-site

The Role

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. 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.

The Candidate

• Doctorate in scientific field with 3-years' experience in lab, 2 in GMP required
• Master's in scientific field with 5+yrs experience in lab, 3 in GMP required
• 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.

Why You Should Join Catalent

• 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

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 [e-mail]. 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.

Catalent 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.