Senior Scientist I – Quality Control

Senior Scientist I, Quality Control (Weekend shift)

Position Summary:

• Work Schedule: Friday- Sunday 6am-6pm
• 100% on-site

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 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.

Catalent Pharma Solutions in Madison, WI is hiring a Senior Scientist I, Quality Control.  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. This position requires a variety of skills necessary for biotech company operations. Perform routine testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. Position will Analyze and interpret results in written and oral format. Additionally, this position will support Preventative Maintenance and basic Laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review and contributions to process improvement initiatives.

The Role:

• Independently executes and properly documents cGMP Quality Control testing.
• Independently operates basic, moderately complex, and complex cGMP Quality Control equipment.
• Authors technical documents such as SOPs and reports.
• Coordinates with Supervisor to prioritize and schedule activities to meet deadlines.
• Supports continuous process improvement initiatives.
• Interacts as an SME for internal and external customers.
• Supports training of specific analytical techniques.
• Performs self-review of analytical data for accuracy and consistency with SOP.
• 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.
• Accurately completes routine and preventive maintenance on basic, moderately complex, and complex equipment.
• 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
• Master’s Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 4 years of industry experience.
• Bachelor’s Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 6 years of industry experience.
• Associate Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 10 years of industry experience.
• High School Diploma or equivalent with a minimum of 11 years of industry experience.
• Preferred:
• Strong understanding of analytical chemistry and simple, moderately complex, and complex lab equipment.
• Experience writing technical documents.
• Experience maintaining and troubleshooting Quality Control equipment.
• Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
• cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.
• Experience following standard operating procedures (SOP).
• General laboratory equipment experience, including micropipettes

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of PTO + 8 paid holidays
• Generous 401K match 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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 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.

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 spam@catalent.com for us to investigate with local authorities.

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