Production Scientist, Downstream/mRNA (3rd Shift, Weds-Sat)

Catalent Pharma Solutions; United States; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

PTO 152 hours + 8 holidays

401K match

Medical, dental, vision

Tuition Reimbursement

Job summary

Catalent Pharma Solutions is seeking a Production Scientist for downstream/mRNA work on the 3rd shift in Madison, WI. Responsibilities include troubleshooting, performing IVT and downstream purification, chromatography, TFF, and maintaining cGMP/GDP compliant documentation.

The role emphasizes following SOPs, continuous improvement, and coaching newer teammates. On‑site position offers a sign‑on bonus and opportunities to engage with client projects and regulatory compliance.

Qualifications

• Requires GMP manufacturing experience preferred.
• Familiarity with cGMP and GDP documentation practices.
• Experience with IVT, purification, purification steps and QC documentation.

Responsibilities

• Perform downstream purification and support mRNA production activities (IVT, chromatography, TFF, viral filtration).
• Follow BPRs and SOPs accurately to ensure right‑first‑time execution.
• Document all activities per GDP; raise deviations via Rapid Response.
• Identify safety/quality improvements and participate in continuous improvement.

Skills

Troubleshooting

Downstream purification

IVT processing

Chromatography

TFF

cGMP / GDP

Documentation (GDP/BPR)

Continuous Improvement

Education

High School Diploma or equivalent

4+ years relevant experience

Bachelors/Associates in science/engineering

Master’s in STEM (no experience required)

Tools

TrackWise

ComplianceWire

JD Edwards

DeltaV

Unicorn chromatography software

Job description

Position Summary

Production Scientist, Downstream/mRNA (3rd Shift, Weds‑Sat)

Work Schedule: 10pm-8am (Wednesday – Saturday)

Location: Madison, WI

Salary: 100% on‑site $5,000 sign‑on bonus offered

Role

• 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 with a focus 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 identifies safety, quality, and efficiency improvements.
• Actively participates in the Catalent Way (Continuous Improvement Culture).
• Leads “Just Do It” (JDI) Continuous Improvement activities and engage 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.
• We will also accept a Bachelors or Associates Degree in a scientific, engineering, or biomanufacturing discipline with 1+ years of experience, or a Master’s in STEM without any formal experience.
• 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

• This position requires 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 for the position.
• Working conditions will be Heating Ventilation and Air Conditioned controlled.
• Ability to operate within a clean room environment as needed.

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 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].

Visit Catalent Careers to explore career opportunities.

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 [e-mail].

«Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.