Scientist I - Quality Control, Data Review

Catalent Pharma Solutions; Alabama; On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Paid time off + holidays

Job summary

Catalent’s Madison site seeks a Scientist I - Quality Control, Data Review to execute and document cGMP QC testing with accuracy. 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 and lab housekeeping while participating in team meetings and training sessions. This is an onsite role in Madison, WI with a defined shift schedule.

Qualifications

• Master’s degree in biology/biotech/chemistry or related life sciences field.
• Bachelor’s degree with minimum 3 years of industry experience.
• Associate degree with minimum 6 years of industry experience.
• High school diploma with minimum 7 years of industry experience.

Responsibilities

• Review a variety of tests and data for accuracy and compliance.
• Read and update SOPs to reflect current methods.
• Perform monthly checks of lab logbooks and ensure GMP/GDP adherence.
• Review analytical and microbiological data for consistency.
• Assist in data entry and lab housekeeping.

Skills

Analytical skills

Lab techniques

Documentation

Education

Master's degree in biology/biotech/chemistry or related life sciences

Bachelor’s degree + 3+ years industry experience

Associate degree + 6+ years industry experience

High school diploma + 7+ years industry experience

Tools

EMPOWER HPLC

HPLC

SEC

CE

cIEF

RP-HPLC

ELISA

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 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.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.