Associate Scientist Ii, Qc

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.
• 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.
• 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.
• Capable of working under moderate supervision. Responsible for login of samples (routine and non-routine) into GLIMS database and logbooks
• May be required to work with potent and teratogenic compounds.
• 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.

The Candidate

• 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.
• H.P.L.C. and G.C. instrumentation experience
• Experience with IR and AA instrumentation
• Experience with U.V. spectroscopy
• 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
• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.

Why You Should Join Catalent

• 19 days accrued PTO + 8 paid holidays
• Generous 401K match
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• Several Employee Resource Groups focusing on D&I
• Employee Stock Purchase Program

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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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