Associate Lead I - Biomanufacturing Compliance - Training

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. 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 2pm‑10pm

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 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.

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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Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

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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.