Job Title: Sr. Analytical Scientist

City: Winchester

State: KY

JOB DESCRIPTION:

• Apply deep and complex knowledge in both the theoretical and practical aspects of analytical chemistry, especially quantitative analysis;
• Utilize spectroscopic, chromatographic and wet chemistry procedures;
• Work with various analytical methods including cleaning verification, assay and impurities, dissolution, residual solvents for raw materials, in-process samples or finished products testing;
• Perform routine quality control testing for raw materials, in-process samples and finished product for commercial manufacturing operations;
• Utilize analytical techniques including, troubleshooting of HPLC or GC instrumental problems, dissolution methods, or related substance assays;
• Communicate analytical results and potential issues with supervisors and necessary team members;
• Perform peer review of analytical testing and write up as necessary.
• Maintain contemporary, accurate, legible, and complete experimental records in accordance with Good Manufacturing Procedures (GMP) and Standard Operational Procedures (SOPs);
• Utilize drug product formulations and manufacture processes to work closely with product development and process transfer teams on testing of product development and process validation batches and providing proper data interpretation;
• Prepare and review technical documents, including validation/transfer/verification protocols and reports, analytical test procedures, technical reports, and analytical investigations for review;
• Conduct studies for method development/evaluation, validation, transfer and verification according to scientific justifications and current regulatory guidance (e.g., ICH, FDA, USP, EP, etc.);
• Provide training to Quality Control Analysts after methods are validated/transferred/verified;
• Author and review SOP’s that fall within defined area of subject matter expertise;
• Develop discriminatory dissolution methods to identify the suitable formulation for clinical studies
• Perform pre formulation studies to identify and develop stable drug product formulations
• Perform forced degradation studies to derive the specifications for degradation impurities compliant with ICH Q3B guidelines
• Write the specification and justify the limits as per ICH Q3B
• Perform risk assessment of elemental impurities as per ICH Q3D and conduct the analysis based on the risk assessment using ICP-MS/OES instrument.
• Work closely with stability team and compile the stability summary data and reports required for the regulatory filings.

EDUCATION AND EXPERIENCE: Requires a Master’s degree in Chemistry or Related Occupation and 2 years of experience in job offered or 2 years of experience in the Related Occupation.

RELATED OCCUPATION:

Analytical Scientist or any other job title performing the following job duties:

Applying deep and complex knowledge in both the theoretical and practical aspects of analytical chemistry, especially quantitative analysis; Utilizing spectroscopic, chromatographic and wet chemistry procedures; Working with various analytical methods including cleaning verification, assay and impurities, dissolution, residual solvents for raw materials, in-process samples or finished products testing; Performing routine quality control testing for raw materials, in-process samples and finished product for commercial manufacturing operations; Utilizing analytical techniques including, troubleshooting of HPLC or GC instrumental problems, dissolution methods, or related substance assays; Communicating analytical results and potential issues with supervisors and necessary team members; Performing peer review of analytical testing and write up as necessary. Maintaining contemporary, accurate, legible, and complete experimental records in accordance with Good Manufacturing Procedures (GMP) and Standard Operational Procedures (SOPs).

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 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.

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