Associate Scientist II, Quality Control

St. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St. Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.

Position Summary

We have an opportunity for an Associate Scientist II - Quality Control to join our team. In this role, you will perform analysis of finished products, in-process materials, raw materials, and validation samples following established specifications and protocols. You will also handle microbiological identification, prepare reagents, and maintain accurate records in compliance with Good Manufacturing Practices. This position requires attention to detail, adherence to safety standards, and the ability to work under moderate supervision in a dynamic laboratory environment.

Shift: Tuesday-Saturday, 8am-5pm, Salaried
Location: St. Petersburg, FL
100% Onsite

The Role

• Analyze finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to assigned specifications, methods, and protocols.
• Perform analysis of finished products, validation samples, moisture testing, gas, water, and environmental sampling and testing following effective specifications, protocols, and compendial monographs.
• Cultivate and identify microorganisms on selective and non-selective media; maintain cultures per ATCC and departmental Standard Operating Procedures.
• Identify microorganisms using techniques such as API and Gram Stain.
• Prepare reagents, standards, and media needed for analysis.
• Work with potent and teratogenic compounds as required.
• Log samples into GLIMS database and logbooks; interpret and record results in approved notebooks, reports, and logbooks.
• Perform basic statistical analysis to support testing; verify calculations and results for accuracy and integrity.
• Assist with receiving, labeling, and storing solvents and reagents; maintain inventory of glassware, chemicals, and materials.
• Calibrate analytical equipment such as balances, pH meters, and KF analyzers; maintain and clean laboratory instruments and equipment.
• Dispose of hazardous waste according to regulations and procedures.
• File and maintain laboratory records following Good Manufacturing Practices and applicable SOPs.
• Assist in writing, reviewing, or revising procedures and laboratory investigations.
• Perform other laboratory-related duties as required, including cleaning glassware.
• Work shifts in support of manufacturing, including weekends and holidays; hours may change based on departmental needs.

The Candidate

Minimum Requirements

• Bachelor’s degree required.
• Ability to work effectively under pressure to meet deadlines.
• Ability to sit, stand, walk regularly and occasionally lift up 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.
• Be accessible to manufacturing, laboratory, and office staff.
• Ability to use required office equipment.

Preferred Skills & Background

• UV spectroscopy, IR and AA instrumentation, HPLC and GC instrumentation, autoclave and Vitek systems, dissolution testing,
• Wet chemistry techniques such as titrations, extractions, digestions, and preparation of test solutions.
• Knowledge of safety and hazardous waste requirements, data acquisition applications and databases, and conducting and writing laboratory investigations.

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continual improvement and innovation.
• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement to help you finish your degree or earn a new one.
• Employee Resource Groups focusing on diversity and inclusion.
• Environmentally friendly initiatives, including regular participation in beach clean-up activities.
• Defined career path with annual performance reviews and potential for growth within an expanding team.
• WellHub program promoting physical and mental wellness.
• Perkspot offering exclusive discounts from over 900 merchants in various categories.

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

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