Associate - Biomanufacturing, Downstream/mRNA

Catalent; Madison (WI); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Defined career path

Generous 401(k) match

Medical, dental, and vision benefits

Tuition Reimbursement

Job summary

Catalent in Madison, Wisconsin is looking for a Biomanufacturing Associate to join their team. This on-site position involves manufacturing biopharmaceutical products in a clean room environment, following strict procedures and quality guidelines.

The ideal candidate should have a High School Diploma plus 4 years of experience or a relevant degree. Benefits include a defined career path, generous PTO, and a 401(k) match.

Qualifications

• High School Diploma or equivalent and 4+ years of relevant experience.
• GMP manufacturing experience preferred.
• Ability to operate in a clean room environment.

Responsibilities

• Perform basic troubleshooting and downstream purification for mRNA production.
• Accurately follow Batch Production Records and Standard Operating Procedures.
• Document all activities as per Good Documentation Practices.

Skills

Microsoft Word

Excel

GMP manufacturing

Chromatography

Education

High School Diploma or equivalent

Bachelor’s or Associate’s Degree in scientific field

Master’s in STEM

Tools

TrackWise

ComplianceWire

JD Edwards

DeltaV

Job description

Work Schedule: 6am-4pm (Sunday-Wednesday or Wednesday–Saturday shift availability). 100% on-site.

Position Summary

Biomanufacturing Associate position, intermediate level, responsible for manufacturing biopharmaceutical products within a clean room environment, following detailed instructions and established procedures under supervision.

Responsibilities

• Performs basic troubleshooting and downstream purification for mRNA production activities, such as in‑vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, bulk drug substance filling, and column packing/qualification.
• Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and focuses on “right‑first‑time” execution.
• Documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, forms, and other quality documentation.
• Recognizes deviations from the intended procedure and raises awareness through the Rapid Response process, proactively identifying safety, quality, and efficiency improvements.
• Actively participates in the Catalent Way (Continuous Improvement Culture). Leads “Just Do It” (JDI) Continuous Improvement activities and engages in implementation of CI projects.
• May coach more junior team members on basic execution activities and act as an “onboarding buddy” to bring new team members up to speed on culture and basic workplace expectations.
• May become a Certified Trainer and take responsibility for the final sign‑off of training completion for basic execution activities. Interacts with clients during Person In Plant (PIP) or virtual PIP observations to provide updates on batch schedule and status.
• Participates in daily shift huddles and leads shift exchange activities. Performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards.
• Other duties as assigned.

Candidate

• Must have High School Diploma or equivalent plus at least four (4) years of relevant experience. A Bachelor’s or Associate’s Degree in a scientific, engineering, or biomanufacturing discipline with 1+ years of experience, or a Master’s in STEM without any formal experience, is also acceptable.
• GMP manufacturing experience preferred.
• Ability to use Microsoft Word and Excel, and other Office systems.
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and Chromatography software (i.e., Unicorn).
• Physical requirements: frequent sitting, standing, walking, reading, use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting up to 10 pounds and occasional lifting up to 50 pounds. Must comply with EHS responsibilities. Working conditions will be Temperature and Ventilation Controlled. Ability to operate within a clean room environment as needed.

Benefits

• 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 401(k) match.
• Medical, dental, and vision benefits.
• Tuition Reimbursement.

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, confirming your request for an accommodation, and including the job number, title, and location to [e-mail].