Analytical Scientist, Analytical Research & Development

Job Title: Analytical Scientist, Analytical Research & Development (AR&D)

City: Winchester

State: KY

JOB DESCRIPTION:

• Communicate analytical results and potential issues with supervisors and team members;
• Test raw materials, pre-capsulation, stability and finished products;
• Analyze data, performing calculations and document results in laboratory notebooks;
• Prepare and review technical documents, including validation, transfer and verification protocols and reports, analytical test procedures, technical reports, certificates of analysis and operating procedures for accuracy, thoroughness and regulatory compliance;
• Perform Quality Control testing of raw materials and in-process samples for commercial manufacturing operations;
• Conduct studies for method development, evaluation, validation, transfer and verification according to scientific justifications and current regulatory guidance;
• Work closely with product development and process transfer teams on testing of product development and process verification batches to provide proper data interpretation;
• Characterize physiochemical attributes of proteins and molecules to test for quality and stability prior to release;
• Work with various analytical methods including cleaning verification, assay and impurities, dissolution, residual solvents for raw materials, in-process samples and finished product testing;

• Identify process improvements that will reduce cycle time to test and release products by troubleshooting existing methods and perform qualification studies to determine if methods are suitable for transfer to Quality Control;
• Perform Operation, Calibration, Qualification, Preventive maintenance and routine troubleshooting of analytical instruments including pH meter, TOC analyzer, analytical balances, K.F, UPLCs, HPLCs, GCs, AAS, UV/Vis Spectrophotometer, Dissolution apparatus, Laser diffraction Partical size analyzes, Liquid partial counter, ICPMS; and
• Perform all of the above-mentioned work throughout drug development, clinical testing and the commercialization of the pharmaceutical product.

EDUCATION AND EXPERIENCE: Requires a Bachelor’s degree in Biotechnology or Related Field and 6 years of experience in the job offered or 6 years of experience in the Related Occupation.

RELATED OCCUPATION:

AR&D Chemist or any other job title performing all listed job duties.

JOB TIME: Full Time

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.

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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.