Catalent Pharma Solutions Inc

Senior Associate - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions Inc • $70K — $95K *
Madison, WI 53711In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • High School Diploma or equivalent with 7+ years of relevant experience, or Bachelor's/Associate's in a scientific or engineering field with 3+ years of experience, or Master's in STEM with 1+ year of experience.
  • Prior experience in GMP manufacturing is preferred.
  • Proficiency in Microsoft Word and Excel, with familiarity in TrackWise, ComplianceWire, JD Edwards, DeltaV, and Chromatography software being advantageous.
  • Strong understanding of Good Manufacturing Practices (cGMPs).
  • Ability to comply with EHS responsibilities in a clean room environment.

Responsibilities

  • Perform advanced troubleshooting and basic downstream purification for mRNA production activities.
  • Strictly adhere to manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) for right-first-time execution.
  • Document all activities following Good Documentation Practices (GDPs).
  • Recognize deviations from procedures and initiate Rapid Response process.
  • Actively engage and lead Continuous Improvement activities within the Catalent Way.
  • Mentor junior team members and act as an onboarding buddy for new hires.
  • Participate in daily shift huddles and lead shift exchange activities.

Benefits

  • Structured career path with annual performance reviews and feedback.
  • Inclusive and diverse workplace culture.
  • Opportunities for career advancement within a life-saving biopharmaceutical organization.
  • Generous paid time off, including 152 hours of PTO and 8 holidays.
  • Substantial 401K matching contributions.
  • Comprehensive medical, dental, and vision plans.
  • Tuition reimbursement to support educational advancement.
Full Job Description
Senior Associate - Biomanufacturing, Downstream/mRNA

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


The Biomanufacturing Sr. Associate position is an advanced level position in the Manufacturing team and is responsible for providing process and technical leadership during manufacturing of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures.

The Role:
  • Performs advanced troubleshooting and basic 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.
  • Acts as formal mentor for 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 seven (7) years of relevant experience. We will also accept a Bachelors or Associates Degree in a scientific, engineering, or biomanufacturing discipline with 3+ years of experience, or a Master's in STEM with 1+ years of 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!


About Catalent Pharma Solutions Inc

Catalent Pharma Solutions Inc is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. The company operates in four segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. Catalent Pharma Solutions serves customers in various industries, including pharmaceuticals, biotechnology, and consumer health. The company was founded in 2007 and is headquartered in Somerset, New Jersey.
Learn more about Catalent Pharma Solutions Inc
Size
14,000 employees
Industry
Pharmaceuticals & Biotech
Founded
2007
* Ladders Estimates

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