Associate Lead I – Biomanufacturing Compliance – Training Catalent

Ourlivesmadison; Madison, Northern (WI, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Onsite training opportunities

Job summary

Catalent's Madison, Wisconsin site is seeking an Associate Lead I - Biomanufacturing, Training to help design and deliver training programs that ensure quality and compliance in a GMP biomanufacturing setting.

The role focuses on tracking training, leading sessions, developing SOPs, and collaborating with subject matter experts to support continuous improvement while maintaining operational excellence on a 2pm–10pm shift, onsite in Madison, WI.

Qualifications

• Requires GMP training knowledge and ability to apply GMP principles.
• Capable of managing training programs and mentoring staff.
• Experience authoring SOPs and related documentation under guidance.
• Strong English reading/writing and ability to communicate clearly.

Responsibilities

• Track and monitor training, provide accurate reports for compliance.
• Lead training sessions for employees.
• Develop qualifications and evaluations for training effectiveness in manufacturing.
• Assist in developing SOPs and training materials for new processes and systems.
• Collaborate with SMEs to identify needs and performance standards.
• Support quality system evaluations related to cGMP and training requirements.

Skills

GMP knowledge

Training program management

CAPA experience

SOP authoring

English literacy

Education

High School Diploma or GED

Associate’s degree in STEM

Bachelor’s degree in STEM

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 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.

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.