Senior Downstream Biomanufacturing Associate (mRNA)

Catalent Pharma Solutions LLC; Madison (WI); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

152 hours of PTO + 8 paid holidays

401K matching

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent, Inc. in Madison, WI seeks a Senior Associate - Biomanufacturing, Downstream/mRNA to lead downstream purification for mRNA production and ensure cGMP compliance in a 263,000 sq. ft.

GMP facility. The role emphasizes right-first-time execution, documentation per GDPs, and active participation in continuous improvement initiatives. The candidate will mentor junior staff, assist with training sign-off, and collaborate with clients during PIP observations.

Qualifications

• Must have HS diploma or equivalently; alternative degrees with relevant experience accepted.
• Bachelor/Associate degrees in scientific, engineering, or biomanufacturing fields with 3+ years experience or Master’s in STEM with 1+ year experience.

Responsibilities

• Perform advanced troubleshooting and downstream purification for mRNA production activities (IVT, chromatography, TFF, viral filtration, filling).
• Follow BPRs and SOPs per cGMP with right-first-time execution.
• Document activities per GDPs in BPRs and forms.
• Identify deviations and drive safety, quality, and efficiency improvements.
• Lead continuous improvement activities and CI projects; mentor junior team members.
• Potential to be a Certified Trainer and onboard new hires.
• Interact with clients during PIP observations and provide batch status updates.
• Participate in daily shift huddles; maintain 5S in cleanroom and equipment.
• Perform general cleanroom housekeeping and waste disposal.

Skills

GMP knowledge

Biomanufacturing

Problem solving

Education

High School Diploma or equivalent

Bachelor's degree in science/engineering/biomanufacturing

Associates Degree in science/engineering/biomanufacturing

Master’s degree in STEM

Tools

TrackWise

ComplianceWire

JD Edwards

DeltaV

Unicorn (Chromatography software)

Job description

Catalent, Inc. in Madison, WI seeks a Senior Associate - Biomanufacturing, Downstream/mRNA to lead downstream purification for mRNA production and ensure cGMP compliance in a 263,000 sq. ft.

GMP facility. The role emphasizes right-first-time execution, documentation per GDPs, and active participation in continuous improvement initiatives. The candidate will mentor junior staff, assist with training sign-off, and collaborate with clients during PIP observations.