Senior Scientist, Analytical Research & Development

About the role

The Senior Scientist, Analytical Research & Development at Catalent is responsible for developing, validating, and executing analytical test methods. This role involves raw material evaluation, testing of non-commercial materials, and supporting product development and manufacturing processes. The position requires extensive experience in identification or separation techniques such as HPLC, UPLC, GC, MS, and NMR.

Responsibilities

• Independently develop, validate, and 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
• 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
• 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

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

Qualifications

• 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.

Skills

• Strong analytical skills
• Excellent communication and presentation skills
• Ability to work independently and as part of a team
• Knowledge of cGMP and regulatory requirements

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

Pay

Competitive pay offered.

Schedule

Standard Hours; Monday through Friday

Contact

To learn more about this opportunity, visit Catalent Careers.