Technical Services Associate Scientist I

Position Summary

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.

Technical Services is responsible for facilitating commercial technology transfers, ensuring Launch Excellence during the new product introduction process, providing commercial technical support over the lifecycle of all products, and driving continuous improvement throughout the manufacturing environment. The Technical Services Associate Scientist I, executes commercial technology transfers of approved products to Catalent STP as well as provides technical oversight/input on existing commercial products. Successful, timely commercial technology transfers and launches of new products will be performed in a collaborative manner, with this position being the lead technical function, accountable for launch success. Direct operational and investigatory support is required, working closely with the Operations, Quality and Product Development departments 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

• Perform product transfer activities to the manufacturing site from internal sites or business partner locations. Provide technical presentations to senior management as needed (Gate Review).

• Develop manufacturing processes for clinical, registration and commercial batches.

• Prepare Master Batch Records for experimental, registration, scale-up and process validation batches.

• Prepare process development reports and other CMC documentation for regulatory submissions.

• Accurate, timely, and quality performance of all tech transfer activities needed for product submission, approval, and launch.

• Perform Risk Assessment and investigation using investigation tools and techniques (Minitab, GTW….).

• Provide technical presentations to senior management as needed (Gate Review).

• Lead and guide technicians in formulation development and clinical supply manufacturing.

• Other duties as assigned

The Candidate

• BS in a scientific field with 0 years of GMP lab/dept experience required and direct softgel product development experience preferred.

• AS in a scientific field with 5+ years in laboratory experience required and direct softgel product development experience preferred.

• Working knowledge and application of scientific principles and techniques. Exposure to computer software associated with word processing and spreadsheets required with some exposure to statistical software preferred.

• Familiarity with batch processing in a pharmaceutical, cGMP environment.

• Strong knowledge of cGMP Regulatory requirements for process development, technical transfer, and process changes required.

Why You Should Join Catalent

• Cross functional exposure to other areas of Operations

• Medical, Dental, Vision and 401K are all offered from day one of employment

• 152 hours of paid time off annually + 8 paid Holidays

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 DisabilityAccommodations@catalent.com. 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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