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Full-time
high school, associate degree, bachelor degree, postgraduate degree
Sign-on Bonus, 401k Match, Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off
Posted 1d ago
~40 hrs/week
Responsibilities
Responsible for the downstream purification of mRNA products, including chromatography and filtration, within a GMP clean room environment. The role involves following batch production records, documenting activities, and participating in continuous improvement projects.
Requirements
Requires a high school diploma with 4+ years of experience, or a scientific degree with 1+ years of experience, or a Master's in STEM. Preference is given to candidates with GMP manufacturing experience and proficiency in chromatography software.
Full job description
Associate - Biomanufacturing, Downstream/mRNA
Position Summary:
Work Schedule: 10pm-8am (Sunday-Wednesday or Wednesday – Saturday shift availability)
100% on-site
$5,000 sign-on bonus offered
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 Biomanufacturing Associate position is an intermediate-level position in the Manufacturing team and is responsible for the manufacturing of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures under supervision.
The 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.
The 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 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.
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 [email protected]. 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 [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Championing the missions that matter™. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) and trusted partner to pharma, biotech, and consumer health companies worldwide. We put patients first in everything we do, helping people live better and healthier lives through every product we help develop, manufacture and deliver. With over 1,000 active development programs at any given time, we launch over 100 new products and line extensions annually. Catalent has supported half of all FDA approvals over the past decade, and our teams working at over 40 global sites help us produce over 60 billion doses every year.
Our strength lies in our people: teams across our more than 40 sites and thousands of passionate scientists and technicians who bring expertise in development sciences, delivery technologies, and multi-modality manufacturing. What unites us is our commitment to championing our partners’ missions as our own, anticipating customer needs, solving complex challenges and ultimately making a difference in the lives of patients across the globe.
At Catalent, you will be able to directly have an impact, solving problems and ensuring excellence for our customers. Our focus on delivering meaningful outcomes alongside our customers means your work directly impacts millions of people around the world. Join us in championing the missions that matter.
Catalent is headquartered in Tampa, Florida, with over 40 global sites. Visit www.catalent.com to learn more.
Offices: 101 E Kennedy Blvd, Tampa, Florida 33602, US · 14 Schoolhouse Road, Somerset, NJ 08873, US · Frankland Road, Blagrove, Swindon, Wiltshire SN5 8YG, GB · 4-9-17 Akasaka, Minato-ku, Tokyo 107-0052, JP · 160 Pharma Dr, Morrisville, NC 27560, US
Championing the missions that matter™. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) and trusted partner to pharma, biotech, and consumer health companies worldwide. We put patients first in everything we do, helping people live better and healthier lives through every product we help develop, manufacture and deliver. With over 1,000 active development programs at any given time, we launch over 100 new products and line extensions annually. Catalent has supported half of all FDA approvals over the past decade, and our teams working at over 40 global sites help us produce over 60 billion doses every year.
Our strength lies in our people: teams across our more than 40 sites and thousands of passionate scientists and technicians who bring expertise in development sciences, delivery technologies, and multi-modality manufacturing. What unites us is our commitment to championing our partners’ missions as our own, anticipating customer needs, solving complex challenges and ultimately making a difference in the lives of patients across the globe.
At Catalent, you will be able to directly have an impact, solving problems and ensuring excellence for our customers. Our focus on delivering meaningful outcomes alongside our customers means your work directly impacts millions of people around the world. Join us in championing the missions that matter.
Catalent is headquartered in Tampa, Florida, with over 40 global sites. Visit www.catalent.com to learn more.
Offices: 101 E Kennedy Blvd, Tampa, Florida 33602, US · 14 Schoolhouse Road, Somerset, NJ 08873, US · Frankland Road, Blagrove, Swindon, Wiltshire SN5 8YG, GB · 4-9-17 Akasaka, Minato-ku, Tokyo 107-0052, JP · 160 Pharma Dr, Morrisville, NC 27560, US