Senior Scientist I, QC

Senior Scientist I - Quality Control, Method Validation.

Summary

Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.

The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment to ensure the Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility.

The Method Validation team is responsible for analytical testing, data analysis, document writing, and data reporting to support phase-appropriate method validation of analytical methods. These methods directly support the Stability and Release and In-Process testing teams.

This is a full-time on-site position, Monday – Friday 8am-4:30pm.

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

• Independently executes and properly documents cGMP Quality Control Methods and testing.
• Authors technical documents such as SOPs and reports.
• Interacts as an SME for internal and external customers.
• Supports training of specific analytical techniques.
• Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
• Performs general lab housekeeping in adherence to 5S standards.
• Initiates and leads investigations or deviations in Trackwise.
• Performs self-review of analytical data and technical review of peers' analytical data for accuracy and consistency with SOP's.
• Actively participates in team meetings and/or training sessions.
• Other duties as assigned.

The Candidate

• PhD Degree in Biology, Biotechnology, Chemistry or related life sciences field; OR
• Master's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 4 years of industry experience; OR
• Bachelor's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience; OR
• Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 10 years of industry experience; OR
• High School Diploma or equivalent with a minimum of 11 years of industry experience
• Experience writing technical documents.
• Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
• cGMP, Good Documentation Practices (GDP) or Good Laboratory Practices (GLP) knowledge experience.
• HPLC, CE experience required, (icIEF) strongly preferred.
• Strong understanding of analytical chemistry and simple, moderately complex, and complex lab equipment.

Physical Requirements

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping.
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
• Must comply with EHS responsibilities for the position.
• Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.
• Working conditions will be Heating Ventilation and Air Conditioned controlled.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

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.

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