Senior Associate

Kelly; Madison (WI); On-site; USD 76,000 - 79,000; Full time

Benefits offered by this job

401K match

Medical, dental, vision benefits

Paid time off including holidays

Job summary

Kelly is seeking a Senior Associate for Biomanufacturing, Downstream/mRNA in Madison, WI. The role operates on-site in a GMP facility with a 2pm–12am shift (Sun–Wed or Wed–Sat). Compensation ranges from $76,000 to $79,000 plus a 10% shift differential.

Responsibilities include troubleshooting downstream purification steps for mRNA, following BPRs and SOPs, GDP documentation, and leading continuous improvement projects. Mentoring and onboarding duties may apply.

Qualifications

• Degree or equivalent with relevant biomanufacturing experience.
• Experience in GMP manufacturing environments preferred.
• Proficient with MS Office and SOPs.
• Knowledge of cGMP and GDP practices is desirable.

Responsibilities

• Perform downstream purification activities for mRNA production.
• Follow BPRs, SOPs, and GDP in a cGMP setting.
• Identify deviations and drive safety, quality, and efficiency improvements.
• Mentor junior staff and participate in onboarding.
• Lead shift huddles and communicate with clients in PIP meetings.

Skills

Biomanufacturing

Troubleshooting

Mentoring

GDP/Documentation

Education

High School Diploma or equivalent

Associate's or Bachelor's in science/engineering/biomanufacturing

Master's degree in STEM

Tools

TrackWise

ComplianceWire

JD Edwards

DeltaV

Unicorn

Microsoft Word

Microsoft Excel

Job description

Senior Associate – Biomanufacturing, Downstream/mRNA

Location: Madison, WI (100% On-site)

Shift: 2pm–12am (Sunday–Wednesday or Wednesday–Saturday)

Compensation: $76,000–$79,000 ($36.54–$37.98 hourly equivalent) plus a 10% shift differential

Position Summary

A leading Contract Development and Manufacturing Organization (CDMO) is seeking a skilled Senior Associate to join their Biomanufacturing, Downstream/mRNA team at an advanced Good Manufacturing Practice (GMP) facility. This position offers the opportunity to support the production of biopharmaceutical products in a highly specialized environment, using state-of-the-art single-use systems.

Key Responsibilities

• Perform advanced troubleshooting and basic downstream purification activities for mRNA production, including IVT reactions, chromatography, TFF, viral filtration, bulk drug substance filling, and column packing/qualification.
• Accurately follow Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in compliance with cGMP requirements and “right-first-time” execution.
• Document all activities following Good Documentation Practices (GDP).
• Identify deviations and proactively contribute to safety, quality, and efficiency improvements.
• Participate in and lead Continuous Improvement activities and projects.
• Mentor junior team members and serve as an onboarding buddy for new colleagues; may become a Certified Trainer.
• Communicate updates to clients during Person in Plant (PIP) meetings.
• Participate in daily shift huddles, lead shift handovers, and help maintain cleanroom and equipment standards.
• Perform housekeeping and additional assigned duties as needed.

Qualifications

• High School Diploma or equivalent with a minimum of 7 years relevant experience, OR
• Associate’s or Bachelor’s degree in a scientific, engineering, or biomanufacturing field with 3+ years of experience, OR
• Master’s degree in a STEM discipline with 1+ year of relevant experience.
• Previous GMP manufacturing experience preferred.
• Proficiency in Microsoft Word, Excel, and general office software.
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and chromatography software such as Unicorn.
• Ability to meet physical requirements, including routine lifting up to 10 lbs (occasionally up to 50 lbs), and working in a clean room environment.

What’s Offered

• Defined career path with annual reviews and feedback
• Diverse and inclusive work culture
• Opportunities for growth and development within an expanding organization
• 152 hours of paid time off (PTO) plus 8 paid holidays
• Generous 401K match
• Medical, dental, vision benefits
• Tuition reimbursement support

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.