Analytical Laboratory Clerk, Research & Development

Analytical Laboratory Clerk, 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 that 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 department provides analytical services to manufacturing, process development, validation and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also support CMC development activities in support of client regulatory filings.  Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg’s Quality departmental policies.

The Analytical Laboratory Clerk, Research and Development supports AR&D by maintaining an operating laboratory, including tasks such as: disposing of laboratory waste, stocking the warehouse with solvents, ensuring solvents in the laboratory are stocked, restocking of lab consumables, performing routine review of standard inventory and removal of expired standards, and other services as necessary. The Analytical Laboratory Clerk, R&D is responsible to maintain reference standard and column inventories as well as reference standard COA database.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.  

The position is 100% on-site at our St. Petersburg, FL location.

The Role  

• Responsible to maintain reference standard and column inventories as well as reference standard COA database.

• On a routine basis, ensures that the laboratory is in an audit ready state.  The laboratory assistant will be responsible for cleaning of the dissolution baths, water baths, sonicators, and wiping down the bench tops.

• Assist with gathering of supplies for analysts to execute daily work assignments.

• Performs additional daily cleaning of communal areas to ensure hygienically safe for next user. 

• Ensures general use equipment areas are neat, clean and clear. 

• Assists with gathering data and making copies of reports and notebooks for customer and regulatory audits.

• Separately, assists with providing copies of notebook pages to auditors for efficient auditing process on an as needed basis. 

• Embraces the continuous improvement attitude and contributes to laboratory operational excellence. Assists others in the implementation of continuous improvement initiatives in the laboratory.

• Maintains a safe work environment.  Builds and maintains communication and collaboration with various departments such as product development, quality control, safety, metrology, quality assurance and others as necessary. 

• Comply with Catalent, FDA, EPA and OSHA regulations, performing all work in a safe manner.

• Other duties as assigned. 

The Candidate  

• Requires a minimum of a high school diploma. 

• Previous experience in chemical, medical or pharmaceutical setting or laboratory a plus.

• General understanding of both chemical and biological hazards.

• Vision Requirement:  ability to read documents in English.

• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and o