Biomanufacturing Training Lead I

Catalent; Madison (WI); On-site; USD 65,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits (

Tuition reimbursement)

Paid time off

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. The 102,700‑square‑foot GMP site specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, with flexible single‑use systems to enable rapid scale‑up.

The Associate Lead I - Biomanufacturing, Training role supports training compliance and leads

Qualifications

• Proficiency with quality and scientific systems (TrackWise, ComplianceWire, JD Edwards, Unicorn).
• Experience applying GMP principles to high-quality procedures.
• Ability to learn manufacturing and laboratory operations.
• Experience with deviation investigations and CAPA.
• Experience in authoring/editing SOPs under guidance.

Responsibilities

• Lead training sessions and track training compliance metrics.
• Assess training requirements with managers and address learning needs.
• Develop qualifications and evaluations for manufacturing training.
• Design training materials including SOPs, FDA GMP, and EH&S topics.
• Support SOP training for new processes and technologies.
• Collaborate with SMEs to identify needs and performance standards.
• Assist on the floor with safety improvements and QA training.
• Maintain training records and communicate policy updates.
• Evaluate effectiveness of the Quality system as it relates to training.
• Support 5S housekeeping and on‑site shift coverage.

Skills

Microsoft Office

TrackWise

ComplianceWire

JD Edwards

Unicorn

GMP principles

SOP authoring

CAPA investigations

Training delivery

Quality systems

Education

Associate7s degree in STEM

Bachelor7s degree in STEM

High School Diploma or GED

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Job description

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. The 102,700‑square‑foot GMP site specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, with flexible single‑use systems to enable rapid scale‑up.

The Associate Lead I - Biomanufacturing, Training role supports training compliance and leads