Associate Scientist II, Analytical Research & Development

Associate Scientist II, 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 Associate Scientist II, Analytical Research & Development once trained will independently test raw materials to both compendial and non-compendial methods.  Once trained, the Associate Scientist II, Analytical Research & Development independently test pre-capsulation, stability and finished product samples as per established methods.  

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

The Role 

• Perform compendial and non-compendial testing on raw materials, drug substances, in-process samples, cleaning samples and finished products as required. 

• Performs assay/CU/dissolution and other single analyte chromatographic testing. Prepares reagents, standards, media and mobile phase as needed for analyses.

• Required to work with potent and teratogenic compounds with proper PPE equipment. Disposal of hazardous waste according to environmental regulations and company procedures.

• Tabulation/ interpretation of results of analysis as recorded in notebooks, reports and logbooks. Assures right-first-time execution of departmental methods and SOPs.

• Supports activities and services necessary to the operations of the department, as assigned. Writes/ reviews analytical methods, deviations, protocols, SOPs and other technical documents.

• Supports Material Evaluation Process for new materials. Shares responsibility for the routine calibration of analytical equipment such as, but not limited to balances, pH meters, KF analyzers, AA, IR, etc. 

• Provides project support for new product development programs under the direction of the lead scientist or group leader. Assist with laboratory investigations using the appropriate Root Cause Analysis tools.

• Participates in inter-departmental task teams. Interfaces with peers in other departments and management. Identifies/implements improvements that will reduce cycle time for testing/release products.

• Other duties as assigned.

The Candidate 

• Associate’s in science with 10 plus years in an analytical lab, 5 in GMP environment OR

• Bachelor’s in science with 3 plus years in an GMP analytical lab 

• Experience with common pharmaceutical equipment: UV/VIS, IR, AA, and Dissolution required.

• Expertise in wet chemistry techniques such as titrations, extractions as per compendia required.

• Familiar with separation chromatographic instruments such as HPLC/UHPLC and GC required. 

• Familiar with pharmaceutical software such as LIMS, TrackWise, Empower, preferred.

• 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.