Scientist I, Analytical Research & Development

Position Summary 

Catalent, Inc. 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.

St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, in-process and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of non-commercial products and materials. The Scientist I, Analytical Research & Development will assist with Development and Validation with some supervision. The Scientist I, Analytical Research & Development will run routine test methods in support of drug substance and drug product sample testing as required. 

Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

The Role

• Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.

• Preparation of reagents/standards/medias needed for analysis according to methods.

• Safe handling of potent and teratogenic compounds. Disposal of hazardous waste according to environmental regulations and company procedures.

• Tabulation/interpretation of results as recorded in notebooks, reports and logbooks.

• Assures right-first-time execution of departmental methods and SOPs.

• Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.

• Assist with writing and reviewing analytical methods, protocols and SOPs. Supports Material Evaluation Process for new materials if required.

• Other duties as assigned.

The Candidate

• Bachelor’s degree (BS) in a scientific field with 5 plus years’ experience in lab, 3 in GMP required OR

• Master’s degree (MS) in a scientific field with 3 plus years’ experience in GMP lab required OR

• Doctorate in scientific field with 1 plus years’ experience in lab required.

• Experience with common pharmaceutical laboratory techniques such as: UV/VIS, IR and AA Spectroscopy HPLC, UHPLC and GC separations Dissolution, Rupture and Disintegration testing, Expertise in wet chemistry techniques such as titrations, extractions and digestions. 

• Knowledge of the following: Safety and hazardous waste requirements, Data acquisition applications and databases, Sound foundations of cGMPs, ICH and USP/EP guidance documents.

• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.

• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.

Why you should join Catalent: 

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• 152 hours of PTO + 8 paid holidays.

• Medical, dental and vision benefits effective day one of employment. 

• Defined career path and annual performance review and feedback process.

• Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

• Dynamic, fast-paced work environment.

• Positive working environment focusing on continually improving processes to remain innovative.

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. 

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.