Scientist I, Analytical Research & Development

Catalent - St. Petersburg, FL

Full-time - Entry Level

St. Petersburg, FL

Chemical Manufacturing

About the position

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. The St. Petersburg facility is our primary soft gel development and manufacturing site in North America, with a 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 the 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. This role involves running routine test methods in support of drug substance and drug product sample testing as required. The responsibilities include the analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to assigned specifications, methods, and protocols. The position requires the preparation of reagents, standards, and media needed for analysis according to methods, as well as the safe handling of potent and teratogenic compounds. Proper disposal of hazardous waste according to environmental regulations and company procedures is also essential. The Scientist I will tabulate and interpret results as recorded in notebooks, reports, and logbooks, ensuring right-first-time execution of departmental methods and SOPs. This role supports activities and services necessary for the routine operations of the department, audits and verifies results, and assists with writing and reviewing analytical methods, protocols, and SOPs. Additionally, the Scientist I supports the Material Evaluation Process for new materials if required and performs other duties as assigned.

Responsibilities

• Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to assigned specifications, methods, and protocols.
• Preparation of reagents, standards, and media 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 and interpretation of results as recorded in notebooks, reports, and logbooks.
• Assures right-first-time execution of departmental methods and SOPs.
• Supports activities and services necessary to the routine operations of the department.
• Audits and verifies results, including 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.

Requirements

• Bachelor's degree (BS) in a scientific field with 5 plus years' experience in lab, 3 in GMP or Master's degree (MS) in a scientific field with 3 plus years' experience in GMP lab or Doctorate in scientific field with 1 plus years' experience in lab.
• 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 safety and hazardous waste requirements, data acquisition applications and databases, sound foundations of cGMPs, ICH and USP/EP guidance documents.

Benefits

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes