Scientist I - Quality Control, Data Review

Catalent Pharma Solutions; Alabama; On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Competitive PTO + 8 holidays

Job summary

Catalent’s Madison site seeks a Scientist I in Quality Control, Data Review to execute cGMP testing with accuracy. You will operate basic/moderate lab equipment, assist in drafting docs, and review data for consistency while supporting data entry and lab housekeeping.

The role emphasizes adherence to GMP/GDP, SOPs, and routine logbook checks. Join a growing biopharma team committed to quality and continuous improvement.

Qualifications

• Master’s Degree in Biology, Biotechnology, Chemistry, or related life sciences field.
• Bachelor’s Degree with a minimum of 3 years of industry experience.
• Associate Degree with a minimum of 6 years of industry experience.
• High School Diploma with a minimum of 7 years of industry experience.
• Strong understanding of analytical chemistry and lab equipment.
• Familiarity with clean room procedure, aseptic technique, and general lab equipment.
• Knowledge of cGMP, GDP, or GLP.
• Experience following SOPs and general lab equipment like micropipettes.

Responsibilities

• Review a variety of different tests.
• Read and update standard operating procedures (SOPs).
• Perform monthly routine checks of logbooks in the lab.
• Ensure adherence to protocols and methods.
• Follow GMP and GDP guidelines.
• Review analytical and microbiological data.
• All other duties as assigned.

Skills

SOP experience

GMP knowledge

Laboratory techniques

Micropipette handling

Education

Master's Degree in Biology/Biotechnology/CChemistry

Bachelor’s Degree + 3 years industry

Associate Degree + 6 years industry

High School Diploma + 7 years industry

Tools

EMPOWER HPLC

SEC

CE

cIEF

RP-HPLC

ELISA

Plate-based assays

Job description

Scientist I - Quality Control - Data Review

Position Summary:

• Shift: M-F 8am-5pm
• 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, Data Review to join our team. In this role, you will execute and document cGMP Quality Control testing with accuracy and compliance. You will operate basic and moderately complex equipment, assist in authoring technical documents, and review analytical data for consistency. You will also support data entry, lab housekeeping, and preventive maintenance while contributing to team meetings and training sessions.

The Role:

• Review a variety of different tests
• Read and update standard operating procedures (SOPs)
• Perform monthly routine checks of logbooks in the lab
• Ensure adherence to protocols and methods
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Review analytical and microbiological data
• All 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
• Preferred: Strong understanding of analytical chemistry and simple and moderately complex lab equipment
• Familiarity with clean room procedure, aseptic technique, and general lab equipment experience
• Knowledge of cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP)
• Experience following standard operating procedures (SOP)
• General laboratory equipment experience, including micropipettes

Preferred Skills & Background

• Experience with EMPOWER system for High-Performance Liquid Chromatography (HPLC)
• Knowledge of Size Exclusion Chromatography (SEC), Capillary Electrophoresis (CE), Capillary Isoelectric Focusing (cIEF), and Reverse Phase HPLC (RP-HPLC)
• Background in Enzyme-Linked Immunosorbent Assay (ELISA) and plate-based assays
• Experience with compendial methods, appearance, pH, concentration, and osmolality testing

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]. 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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