Associate Scientist II, Analytical Research & Development

Associate Scientist II, Analytical Research & Development

Position Summary

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

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.

Once trained, the Associate Scientist II will independently test raw materials to both compendial and non-compendial methods. Once trained, the Associate Scientist II independently test pre-capsulation, stability and finished product samples as per established methods. Analyze data, document results, maintain laboratory notebook according to cGMP and internal SOPs. Communicate results in written and oral presentation as needed. 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.

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 Role

• Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and 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.

• Writes/ reviews analytical methods, deviations, protocols, SOPs and other technical documents.

• Shares responsibility for the routine calibration of analytical equipment such as, but not limited to balances, pH meters, KF analyzers, etc.

• Other duties as assigned.

The Candidate

• AS in science with 10 plus years in an analytical lab, 5 in GMP environment, or BS in science with 3 plus years in an GMP analytical lab.

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

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds.

• Working with potential hazards will require wearing proper personal protective equipment.

Why You Should Join Catalent

• Competitive medical benefits and 401K

• 152 hoursof PTO + 8 Paid Holidays

• Dynamic, fast-paced work environment

• Opportunity to work on Continuous Improvement Processes

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 ~~~ . 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ~~~ for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (~~~) .