Associate Lead I - Biomanufacturing, Compliance

Catalent; Madison (WI); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision benefits (

Tuition Reimbursement

Paid time off & holidays

Day-one benefits availability

Résumé du poste

Catalent in Madison, Wisconsin, seeks an Associate Lead I - Biomanufacturing, Compliance to support cGMP manufacturing operations and ensure adherence to SOPs and regulatory requirements. This role helps maintain quality and drives continuous improvement in a high‑performing team.

The position emphasizes thorough deviation investigations, internal audits, CAPA implementation, and ongoing cGMP training, with a 100% onsite schedule on a night shift.

Qualifications

• Requires knowledge of cGMP principles and quality systems.
• Experience with deviation investigations and CAPAs.
• Ability to author and edit SOPs and related documentation.

Responsabilités

• Facilitate Rapid Response Team when deviations occur and document root cause data.
• Review logbooks for cGMP compliance and track investigations.
• Support internal audits and assist in corrective actions.
• Identify training needs and communicate policies affecting GMP.
• Assist in SOP creation for new processes or technologies.
• Contribute to safety improvements and provide floor support.
• Participate in CAPA programs and ongoing cGMP training.
• Perform other duties as assigned.

Connaissances

cGMP knowledge

CAPA & deviation

SOP writing

Data review

Microsoft Office

Formation

High School Diploma

Associate’s degree in STEM

Bachelor’s degree in STEM

Outils

TrackWise

ComplianceWire

JD Edwards

Unicorn

Description du poste

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, Compliance to join our team. This role supports cGMP manufacturing operations and ensures compliance with Standard Operating Procedures, regulatory, and client requirements. The position plays a key part in maintaining quality and compliance standards while contributing to continuous improvement initiatives. It offers the chance to work in a dynamic environment dedicated to patient safety and operational excellence.

Shift

Wednesday - Saturday, 11:00pm - 9:00am

($5,000 Sign-On Bonus Available)

Location: Madison, WI

100% Onsite

The Role

• Facilitate Rapid Response Team as deviations occur, documenting critical information to determine true root cause.
• Provide timely review of logbooks to ensure data complies with cGMP expectations and assist in tracking and monitoring open investigations.
• Participate in initiatives to improve process compliance culture, including ongoing cGMP understanding, self-audit, and CAPA programs.
• Participate in internal audits and assist in closure of applicable findings.
• Identify and assist with training issues, instruction problems, or new educational needs for employees or equipment.
• Inform personnel of communications, decisions, and policies affecting performance and GMP compliance.
• Support authoring Standard Operating Procedures (SOPs) for new processes, systems, or technologies or when gaps are identified.
• Assist in identifying safety improvements and provide on-the-floor manufacturing support.
• Other duties as assigned.

Minimum Requirements

• High School Diploma or GED with at least 4 years of related experience, or an Associate’s degree in a STEM field with 1 year of related experience, or a Bachelor’s degree in a STEM field with no experience required.
• Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and Unicorn®.
• Applies cGMP principles and best practices to ensure compliant, high-quality execution of procedures.
• Demonstrates 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 with authoring and editing SOPs and related documentation under guidance.
• Physical requirements: 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 EHS responsibilities.

Preferred Skills & Background

• GMP experience in manufacturing or quality.

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].

Volunteer Work Disclosure:

Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

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.