Associate Scientist II, QC

Position Summary

St. Petersburg is our softgel development and manufacturing Center of Excellence in North America, with capacity of 18 billion capsules per year. We are the inventors of the rotary die encapsulation process featured in RP Scherer softgel technology which delivers a consumer preferred oral drug delivery solution which can enhance bioavailability of poorly soluble API. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Quality Control laboratory supports testing and release of raw materials, intermediate and finished products, and all critical systems supporting manufacturing operations such as purified and potable water, compressed gases, captive zone environmental analysis, as well as cleaning and process validation support. The department provides analytical services to manufacturing, Technical Services, Validation and new material qualifications. A

The Associate Scientist II, QC will independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. The Associate Scientist II, QC communicate results in written and oral presentations. Help in writing Procedures, Specifications and Test Methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies.

If you share a passion for patient care in the growing world of pharmaceutical manufacturing and would like to be part of a global drug development and delivery leader, then this might be for you!

The Role

• Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
• Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water and manufacturing environmental sampling and testing according to the effective Specifications, protocols, Methods and Compendial monograms.
• Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.
• Maintains cultures according to ATCC and departmental Standard Operating Procedures.
• Performs identification of microorganisms using techniques such as API, Gram Stain, etc. Prepares reagents, standards, Medias, etc. needed for analysis.
• May be required to work with potent and teratogenic compounds.
• Capable of working under moderate supervision. Responsible for login of samples (routine and non-routine) into GLIMS database and logbooks
• Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks. Required to perform basic statistics to support analytical testing.
• Other duties as assigned.

The Candidate

• Requires BS or BA with college course work in related sciences. Experience in an analytical laboratory preferred but not required. Must possess good interpersonal skills. Ability to effectively communicate with co-workers. Good organizational skills required
• Experience with U.V. spectroscopy
• Experience with IR and AA instrumentation
• H.P.L.C. and G.C. instrumentation experience
• 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.

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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