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Category

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Research & Development (R&D)

Description

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Position Summary The Pharmaceutical Development Technician reports to the Operations Manager. Pharmaceutical Development Technicians are responsible for the development, optimization and execution of early stage development and clinical batches manufacture in conjunction with Formulations Research & Development and Operations. These responsibilities include operating lab and pilot scale equipment focusing on Controlled Release and Hot Melt Extrusion technologies. Pharmaceutical Development Technicians must have demonstrated experience in setup, operation, changeover and cleaning for all core equipment. All responsibilities are dictated by strict regulations, e.g., cGMPs, SOPs and batch records. Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients. The Role

• Show significant technical skills related to job, e.g., machine set-up and operation, understanding of all machine controls/functions, ability to troubleshoot, etc. with a minimum of 2 years experience with the following technologies at scales from 0.5kg to 50kg:
  • Fluid Bed Spraying and Granulation
  • Hot Melt Extrusion
  • Encapsulation and/or Compression
  • Pan Coating
• Possess problem solving and decision-making skills as related processing challenges and optimizing process execution
• Demonstrate strong technical skills at and consistently troubleshooting and displaying exceptional problem solving skills
• Must have demonstrated outstanding troubleshooting skills and ability to anticipate critical customer issues
• Provide support to Formulation and Formulation Group activities for equipment operation, participation in development batch manufacture, in-process sampling and/or testing, monitoring for oral solid formulations. Conducts relevant trouble shooting for the manufacturing processes when needed.
• Understand and follow all cGMP and SOP regulations

The Candidate

• Minimum of a High School Degree with a two year technical or Associate’s degree preferred
• Prior experience working in a pharmaceutical, biotech or food manufacturing environment (regulated by GMP standards and requirements for at least 2 years) is preferred; with specific experience in oral solid dosage manufacturing (blending, Hot Melt Extrusion, compression, pan coating, fluid bed, or encapsulation manufacturing processes)
• Ability to utilize hand tools to assemble and disassemble various types of machinery
• Ability to follow instructions and procedures (SOPs, cGMPs)

Position Benefits

• Medical, Dental, Vision and 401K are all offered from day one of employment
• 19 days of paid time off annually + 7 paid holidays

Leadership Competencies for Performance and Development

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

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