Senior Scientist, Quality Control

Job Title: Senior Scientist, Quality Control

City: Madison

State: WI

JOB DESCRIPTION:

• Oversee testing of process samples, raw materials, finished products, and stability samples performed at contract testing sites
• Review and approve invoices for contract testing laboratories
• Analyze and interpret results from cell bank characterization testing, unprocessed bulk harvest testing, drug substance and drug product testing
• Review and archive data and contribute to process improvement initiatives
• Use and Operate cGMP Quality Control equipment including Spectramax spectrophotometers, Agilent HPLC, Waters UPLC, PA800 Plus Capillary Electrophoresis instruments, and ICE3 instruments.
• Use validated software including SoftMax Pro, Empower, and Protein Simple CFR to assist in processing data obtained from the analytical instruments and interpreting the results
• Develop comprehensive specifications for the finished products that meet regulatory requirements and industry standards by outlining the acceptable ranges for critical quality attributes such as strength, potency, purity, impurities, and sterility
• Author product specification documents for master cell banks, working cell banks, end of production cells, unprocessed bulk harvest, drug substance, and drug product
• Develop a robust testing strategy for in-process and finished products encompassing a range of analytical techniques to comprehensively evaluate and meet the highest standards of quality, safety, and efficacy.
• Author batch production sampling directives
• Author Certificates of Analysis for cell banks, unprocessed bulk harvest, drug substance and drug product.
• Author viral testing strategy, sampling directive, and product specification SOPs
• Author qualification reports for unprocessed bulk harvest testing methods
• Design and execute in-use compatibility studies for Drug Products
• Lead continuous process improvement initiatives.
• Represent QC as a cell line characterization Subject Matter Experts (SME) for internal and external customers
• Knowledge of FDA, EP, JP, and ICH requirements for biologics and cell banking
• Enter cell bank, unprocessed bulk, drug substance, and drug product data into Labvantage Laboratory Information Management System (LIMS) or laboratory reports
• Initiate and lead investigations or deviations in TrackWise
• Participate in team meetings and/or training sessions

EDUCATION AND EXPERIENCE: Requires a Master’s degree in Chemistry and 6 years of experience in job offered or 6 years of experience in Related Occupation

RELATED OCCUPATION:  

Analyst, Quality Control or any other job title performing the following job duties:

• Executing and properly documenting cGMP Quality Control testing.
• Operating basic and moderately complex cGMP Quality Control equipment.
• Completing routine and preventive maintenance on basic to moderately complex equipment.
• Assisting in authoring technical documents including SOPs and reports.
• Performing self-review of analytical data for accuracy and consistency with SOP and enters data into the Laboratory Information Management System (LIMS) or laboratory reports.
• Coordinating with Supervisor to prioritize and schedule activities to meet deadlines.
• Supporting continuous process improvement initiatives and training in specific analytical techniques.
• Initiating and assisting with records in TrackWise.
• Maintaining batch records and/or laboratory notebook and completing all laboratory documentation in clear and accurate language and according to SOP.
• Attending training and applying learning on routine operation, maintenance, and theory or laboratory instrumentation, SOPs, and regulatory guidelines.
• Peer review data to ensure data is well organized with complete documentation.
• Applying applicable regulatory authority and guidelines with training and demonstrate a theoretical understanding of the work tasks assigned.

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. 

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.

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