Senior Scientist I - Quality Control - Data Review

Catalent Pharma Solutions; Alabama; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Defined career path

Annual performance review

Diversity & inclusion culture

Medical, dental, vision benefits day 1

Tuition reimbursement

Job summary

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. We seek a Senior Scientist I - Quality Control - Data Review to execute cGMP testing, review data, and support lab operations on site in Madison.

The role includes reviewing tests, SOPs, data, and training junior staff, while following GMP and GDP practices.

Qualifications

• Ph.D. 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
• Intermediate to advanced proficiency in Microsoft Office preferred
• Familiarity with EMPOWER software preferred

Responsibilities

• Review a variety of different tests
• Review and update Standard Operating Procedures (SOPs)
• Perform monthly routine checks of logbooks within the lab
• Ensure adherence to protocols and methods
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Review analytical and microbiology data
• Assist with training of junior staff
• Help coordinate day-to-day tasks in the supervisor’s absence
• All other duties as assigned.

Skills

HPLC

SEC

CE

cIEF

RP-HPLC

ELISA

Microsoft Office

Education

Ph.D. in Biology, Biotechnology, Chemistry or related life sciences field

Master’s degree in Biology, Biotechnology, Chemistry or related life sciences field (min 4 years experience)

Bachelor’s degree in Biology, Biotechnology, Chemistry or related life sciences field (min 6 years experience)

Associate degree in Biology, Biotechnology, Chemistry or related life sciences field (min 10 years experience)

High School Diploma or equivalent (min 11 years experience)

Tools

EMPOWER software

EMPOWER system

Job description

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 Senior Scientist I - Quality Control - Data Review to join our team. In this role, you will execute and document cGMP Quality Control testing with precision. You will operate equipment, review analytical data, and ensure compliance with SOPs. You will also contribute to technical documentation and support laboratory operations in a collaborative environment.

The Role

• Review a variety of different tests
• Review and update Standard Operating Procedures (SOPs)
• Perform monthly routine checks of logbooks within the lab
• Ensure adherence to protocols and methods
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Review analytical and microbiology data
• Assist with training of junior staff
• Help coordinate day-to-day tasks in the supervisor’s absence
• All other duties as assigned.

The Candidate

• Ph.D. 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

Intermediate to advanced proficiency in Microsoft Office preferred

Familiarity with EMPOWER software preferred

Preferred Skills & Background

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

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.

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.

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.