Senior Scientist, Analytical Research & Development

Position Summary

• Work Schedule: Standard Hours; Monday through Friday

• 100% on-site

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.

The Candidate

• 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.

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