Associate Lead I - Biomanufacturing, Training

Catalent; Madison (WI); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, vision benefits from

Job summary

Catalent’s Madison, Wisconsin site is a hi‑tech biologics development and manufacturing facility supporting research through early‑ and mid‑stage clinical production. We seek an Associate Lead I - Biomanufacturing, Training to design, deliver, and maintain training programs ensuring quality and continuous improvement.

The role is 100% onsite with a Monday–Friday 10am–6pm schedule, requiring collaboration with managers and subject matter experts to drive training effectiveness and compliance in a

Qualifications

• Bachelor's degree in a STEM field or 4+ years of related experience.
• Proficiency with quality systems (TrackWise, ComplianceWire) and office software.
• Knowledge of cGMP and SOP development, training and documentation.
• Ability to author/edit procedures and participate in CAPA investigations.

Responsibilities

• Lead and track training programs to ensure compliance and operational excellence.
• Design and deliver effective training materials and SOPs for manufacturing teams.
• Collaborate with managers and SMEs to identify learning needs and evaluations.
• Support cGMP training and audit readiness, including quality system improvements.
• Maintain training records and provide metrics for regulatory compliance.

Skills

MS Office

TrackWise

ComplianceWire

JD Edwards

Unicorn

cGMP knowledge

SOP writing/editing

training delivery

Education

B.S./B.A. in STEM

4+ years experience in related field

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Job description

About Site

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.

Position Summary

We have an opportunity for an Associate Lead I - Biomanufacturing, Training to join our team. In this role, you will support training compliance and lead training sessions to ensure operational excellence. You will collaborate with managers and subject matter experts to design and deliver effective training programs. This position plays a key role in maintaining quality standards and supporting continuous improvement in a dynamic biomanufacturing environment.

Shift: Monday-Friday from 10am-6pm

Location: Madison, WI

100% Onsite

The Role

• Support tracking and monitoring of training to provide accurate reports and metrics for compliance.
• Actively lead training sessions for employees.
• Provide input to assess training requirements and work with managers to address learning needs.
• Assist in developing qualifications and evaluations to ensure training effectiveness in the manufacturing department.
• Help design and develop training, including job-specific tasks, SOP training, FDA current Good Manufacturing Practices, Environmental Health & Safety regulations, and general work skills.
• Support authoring of Standard Operating Procedures for new processes, systems, or technologies related to training needs.
• Provide feedback and support revisions of materials based on evaluation findings.
• Collaborate with Subject Matter Experts to identify needs, target audience, and performance standards.
• Assist in safety improvements and provide on-the-floor manufacturing support.
• Assist Quality Assurance with SOP training as needed.
• Participate in team meetings and track/review training records for accuracy.
• Communicate decisions, policies, and information that affect performance and results.
• Assist in evaluating the effectiveness of the Quality system as it relates to cGMP and training requirements.
• Support cleanroom housekeeping and adherence to 5S standards.
• Work scheduled shift and provide off-shift coverage as required.
• Perform other duties as assigned.

The Candidate

Minimum Requirements

• High School Diploma or GED with at least 4+ years of related experience, or an Associate’s degree in STEM with 1+ years of related experience. No experience required with a Bachelor’s degree in a STEM-related field.
• Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and Unicorn®.
• Ability to apply current Good Manufacturing Practices principles and best practices to ensure compliant, high-quality execution of procedures.
• Foundational knowledge of manufacturing and laboratory operations with the ability to learn new processes and techniques.
• Experience with deviation investigations, including corrective and preventive actions (CAPAs).
• Experience authoring and editing Standard Operating Procedures and related documentation under guidance.
• Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with Environmental Health & Safety responsibilities.

Preferred Skills & Background

• Previous experience training and mentoring others on Good Manufacturing Practice best practices and managing a training program.

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. For accessibility accommodations, you may request assistance by emailing [e-mail]. This option is reserved for individuals who require accommodation due to a disability.