Senior Scientist, Analytical Research & Development

Catalent Pharma Solutions; Saint Petersburg (FL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Tuition reimbursement

WellHub program

PTO 152 hours + 8 holidays

Health benefits from day one

Career development path

Inclusive culture and ERGs

Job summary

Catalent in Saint Petersburg, FL, seeks a Senior Scientist in Analytical Research & Development. The role focuses on developing and validating analytical methods for drugs across the development pipeline, with direct client interactions and cross-functional collaboration in a CDMO setting.

You will drive method transfer, ensure data integrity, and support validation activities while working on a diverse portfolio of molecules for softgel products.

Qualifications

• Doctorate in a scientific field with 3+ years in lab and GMP experience.
• Master's degree with 5+ years lab and 3+ years GMP experience.
• Bachelor's degree with 10+ years lab and 8+ GMP experience.
• Minimum 5 years experience with identification or separation techniques (HPLC, UPLC, GC, MS, NMR) and method development/validation.
• VISION: read documents, differentiate color, 20/30 vision; able to work extended hours.

Responsibilities

• Develop, validate, and routinely execute instrumental test methods for Drug Substances/Products and analyze data per cGMP.
• Lead designated projects, including client communications and cross-functional collaboration.
• Analyze finished products, in-process materials, and raw materials per specifications and protocols.
• Write, review, and support methods, deviations, SOPs, and investigations; lead method transfer activities.
• Audit results for accuracy, data integrity; maintain records in notebooks and logs per regulations.
• Safely handle potent/teratogenic compounds; prepare reagents and manage waste disposal.
• Contribute to continuous improvement by training colleagues and coordinating team activities.
• Other duties as assigned.

Skills

HPLC

UPLC

GC

MS

NMR

GMP

Method development

Project leadership

Education

Doctorate in scientific field

Master's in scientific field

Bachelor's in scientific field

Job description

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.

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

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.

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.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.