Scientist I - Quality Control, Microbiology

Catalent Pharma Solutions; Madison, Northern (WI, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Tuition reimbursement

Paid time off

Job summary

Catalent Pharma Solutions in Madison, Wisconsin is seeking a Scientist I in Quality Control – Microbiology. The role involves performing cGMP QC testing, documenting results, and maintaining compliance with SOPs.

You will operate QC equipment, assist in writing SOPs, and ensure accurate data entry in LIMS on a 6am–6pm Sun–Tues shift. The candidate should have a Master’s or Bachelor’s in life sciences with several years of industry experience or higher, familiarity with GMP/GDP, and hands-on lab

Qualifications

• Requires cGMP, GDP/GLP familiarity and strong documentation practices.
• Experience with analytical chemistry and lab equipment.
• Familiar with aseptic technique and clean room procedures.
• Proficient in following SOPs and using LIMS/TrackWise for data entry.

Responsibilities

• Independently execute and document cGMP QC testing.
• Operate routine and moderately complex QC equipment.
• Assist in authoring SOPs and reports.
• Enter data accurately into LIMS and ensure data integrity.
• Maintain lab 5S practices and participate in team meetings.

Skills

cGMP knowledge

GDP/GLP knowledge

Analytical testing

Laboratory techniques

Education

Master’s Degree in Biology/ Biotechnology/ Chemistry

Bachelor’s Degree in Biology/ Biotechnology/ Chemistry

Associate Degree in Biology/ Biotechnology/ Chemistry

High School Diploma with 7+ years industry experience

Tools

HPLC

ELISA

LIMS

TrackWise

Job description

**Scientist I - Quality Control- Microbiology****Position Summary:*** Shift: Sun- Tues 6am-6pm* Location: Madison, WI* 100% OnsiteCatalent’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.