Catalent Pharma Solutions Inc

Principal Scientist - Process Development, Upstream

Catalent Pharma Solutions Inc • $100K — $130K *
Madison, WI 53711In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Ph.D. in Biotechnology or related field with 8-10 years of lab experience; OR MS with 12+ years; OR BS with 15+ years of industry experience.
  • Experience in mammalian cell culture and bioreactor operations.
  • Hands-on process development, scale-up, and transfer experience in a cGMP environment.
  • Strong understanding of Design of Experiments (DoE) and process optimization.
  • Ability to troubleshoot complex process issues and execute corrective actions.
  • Experience authoring SOPs, batch records, and technical documents.
  • Ability to lead multiple complex projects and provide mentorship.

Responsibilities

  • Lead development and implementation of upstream processing methodologies and analytical procedures for cGMP manufacturing.
  • Troubleshoot process issues and monitor outcomes for successful project completion.
  • Design and execute experiments for seed train scale-up and bioreactor operations.
  • Apply DoE for clone screening and process optimization.
  • Support tech transfer ensuring robust processes for cGMP manufacturing.
  • Lead multiple complex projects while serving as a technical consultant.
  • Analyze complex data and integrate results with project objectives.

Benefits

  • Competitive medical benefits and 401K.
  • 152 hours PTO plus 8 paid holidays.
  • Dynamic, fast-paced work environment.
  • Opportunity to engage in Continuous Improvement Processes.
Full Job Description
Principal Scientist - Process Development, Upstream

Position Summary
  • Shift: Monday - Friday 8am-5pm
  • 100% on-site


The Principal Scientist - Process Development, Upstream is responsible for the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures that can be successfully transferred to cGMP manufacturing to generate therapeutic proteins for clinical trials. This role will lead and execute complex process development activities including seed train scale-up, bioreactor operations, and process optimization using Design of Experiments (DoE), while supporting tech transfer to manufacturing. The individual will operate as a technical lead across multiple projects, collaborating cross-functionally and with external clients to ensure robust, scalable processes and successful delivery across early-phase through late-stage development programs

The role:
  • Lead the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures for transfer to cGMP manufacturing
  • Troubleshoot and problem solve process issues, initiate and execute corrective actions, and monitor outcomes to ensure successful project completion
  • Design and execute process development experiments including seed train scale-up, bioreactor inoculation, and production operations
  • Apply Design of Experiments (DoE) for clone screening, process optimization, and defining process parameters and operating conditions
  • Support tech transfer activities to manufacturing, ensuring processes are robust and can be successfully transferred to cGMP manufacturing
  • Lead multiple complex projects at a time and serve as a technical lead providing scientific consultation and direction
  • Analyze and interpret complex data, integrate experimental results with project objectives, and provide insight into potential issues and solutions
  • Collaborate with internal functional areas and external clients to communicate project status and ensure delivery of high-quality processes


The candidate:
  • Ph.D. in Biotechnology or related field with 8-10 years of laboratory experience, OR MS with 12+ years, OR BS with 15+ years of industry experience
  • Experience in development and implementation of upstream process development methodologies, including mammalian cell culture and bioreactor operations
  • Hands-on experience with process development, scale-up, and transfer of processes to cGMP manufacturing
  • Strong knowledge of Design of Experiments (DoE), process optimization, and process parameter definition
  • Experience working in a cGMP environment and applying good documentation practices (GDP)
  • Ability to independently design, execute, and analyze experiments, interpret complex data, and provide insight into potential issues and solutions
  • Ability to troubleshoot and problem solve complex process issues, analyze data, and initiate and execute corrective actions
  • Strong technical writing skills with experience authoring SOPs, batch records, protocols, and technical reports
  • Ability to lead multiple complex projects, communicate effectively with internal and external clients, and provide technical leadership and mentorship


Why you should join Catalent:
  • Competitive medical benefits and 401K
  • 152 hours PTO + 8 Paid Holidays
  • Dynamic, fast-paced work environment
  • Opportunity to work on Continuous Improvement Processes


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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