Scientist I - Quality Control- Microbiology

Catalent Pharma Solutions; Alabama; On-site; USD 65,000 - 85,000; Full time

Job summary

Catalent's Madison site is seeking a Scientist I - Quality Control- Microbiology to perform cGMP QC testing and maintain compliant documentation. The role involves operating QC equipment, contributing to SOPs, and ensuring data integrity within LIMS and TrackWise. Strong aseptic technique and GMP knowledge are required.

The position offers on-site work in Madison, WI with opportunities to collaborate across teams and contribute to biopharmaceutical development and manufacturing.

Qualifications

• Master's or Bachelor's degree with industry experience in life sciences.
• Experience with analytical chemistry and lab equipment.
• Familiarity with cGMP, GDP, GLP and SOPs.

Responsibilities

• Execute and document cGMP QC testing.
• Operate basic to moderately complex QC equipment.
• Assist in authoring SOPs and reports.
• Review analytical data for accuracy with SOPs.
• Enter data into LIMS or lab reports.
• Maintain 5S lab housekeeping.
• Initiate and assist with TrackWise records.
• Perform routine and preventive maintenance on equipment.
• Participate in team meetings and training.
• Perform other duties as assigned.

Skills

cGMP knowledge

GDP/GLP familiarity

SOPs experience

Aseptic technique

Micropipettes

Laboratory equipment handling

LIMS data entry

TrackWise experience

HPLC (preferred)

ELISA (preferred)

Education

Master's Degree in Biology/ Biotechnology/ Chemistry or related life sciences

Bachelor's Degree in Biology/ Biotechnology/ Chemistry or related life sciences with 3+ years experience

Associate Degree in Biology/ Biotechnology/ Chemistry with 6+ years experience

High School Diploma with 7+ years experience

Tools

LIMS

TrackWise

SOP software (if any)

Job description

Position Summary

Shift: Sun- Wed 6am-4pm Location: Madison, WI 100% Onsite

Catalent's Madison, Wisconsin site is a state-of-the-art biologics development and manufacturing facility supporting customers from research through early-and mid-stage clinical production.

Located at 726 Heartland Trail in Madison, the approximately 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single-use systems to enable rapid scale-up and customization.

The site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high-yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing.

Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent's global biologics network and Wisconsin's growing life sciences ecosystem.

We have an opportunity for a Scientist I - Quality Control- Microbiology to join our team. In this role, you will perform cGMP Quality Control testing and ensure accurate documentation. You will operate laboratory equipment, assist in preparing technical documents, and maintain compliance with established procedures. This position involves active participation in team activities and maintaining a clean and organized laboratory environment.

The Role

• Independently execute and properly document cGMP Quality Control testing.
• Operate basic and moderately complex cGMP Quality Control equipment.
• Assist in authoring technical documents such as Standard Operating Procedures (SOPs) and reports.
• Perform self-review of analytical data for accuracy and consistency with SOPs.
• Enter data into Laboratory Information Management System (LIMS) or laboratory reports.
• Perform general lab housekeeping in adherence to 5S standards.
• Initiate and assist with records in Trackwise.
• Accurately complete routine and preventive maintenance on basic to moderately complex equipment.
• Actively participate in team meetings and training sessions.
• Perform other duties as assigned.

The Candidate

• Master's Degree in Biology, Biotechnology, Chemistry or related life sciences field.
• Bachelor's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 3 years of industry experience.
• Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience.
• High School Diploma or equivalent with a minimum of 7 years of industry experience.
• Experience with analytical chemistry and simple and moderately complex lab equipment.
• Familiarity with clean room procedures, aseptic technique, and general lab equipment.
• Knowledge of cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
• Experience following Standard Operating Procedures (SOPs).
• General laboratory equipment experience, including micropipettes.
• Preferred Skills & Background Experience with High-Performance Liquid Chromatography (HPLC) and Enzyme-Linked Immunosorbent Assay (ELISA).

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
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• 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. 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 [e-mail].

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.