Associate Lead I - Biomanufacturing, Compliance

Associate Lead I - Biomanufacturing, Compliance

Position Summary:

• Work Schedule: Sunday – Wednesday, 2pm-12am
• 100% on-site (Madison, WI)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Associate Lead I for Biomanufacturing Compliance helps drive the end-to-end execution of clinical and commercial production in a cGMP environment, delivering high-quality biologics in alignment with regulatory and client requirements. The team’s capabilities span solution preparation, cell banking, upstream and downstream processing, mRNA and molecular therapeutics, and small-scale fill/finish. Operating through integrated Process Execution and Process Compliance teams, Manufacturing ensures safe, right-first-time batch delivery while embedding continuous improvement to optimize processes, increase efficiency, and expand capacity. This collaborative model enables strong on-the-floor support, rapid issue resolution, and consistent adherence to compliance standards which creates a high-impact, growth-oriented environment for professionals in biomanufacturing.

The Role:

• Facilitate Rapid Response Team as deviations occur, documenting critical information to determine true root cause.
• Provide timely review of logbooks as needed to ensure data complies with cGMP expectations. Actively engage in Inspection Readiness activities and teams.
• Assist to track/monitor and provide timely, accurate information regarding status of open investigations.
• Participate in initiatives to improve process compliance culture, including on-going cGMP understanding and application, including 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 regarding specific employees or groups or equipment.
• Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results as it relates to GMP compliance.
• Supports authoring Standard Operating Procedures (SOPs) for new processes, systems or technologies or when gaps are identified.
• Assists in identifying improvements for safety and provides on the floor manufacturing support.
• Other duties as assigned.

The Candidate:

• Must have a minimum of High School Diploma/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 STEM related field.
• Related experience encompasses proficiency in Microsoft Office and capable of learning and using quality and scientific systems (e.g., TrackWise®, ComplianceWire®, JD Edwards®, 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.

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
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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 DisabilityAccommodations@catalent.com. 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.