Job Description

SUMMARY

 This entry-level position is responsible for support of CMC activities as well as working with Scientists and management for specific compound development at CritiTech in support of CritiTech product development and associated affiliates/partners for the global development and regulatory approval of New Chemical Entities (NCE’s), Active Pharmaceutical Ingredients (APIs) and support of research and development of any/all product activities.

  RESPONSIBILITIES

 Takes directions and operates equipment in support of research, development and analytical needs of the laboratory operations

• Setup, operate, and clean spray drying equipment
• Setup, operate, and clean SCP equipment
• Setup, operate, and clean fill/finish equipment (vial filling, capsule filling, blender)
• Perform daily checks on balances, temperatures, humidity, and differential pressures
• Perform weekly and monthly cleaning of facility (both 1845 and 1849 facilities)
• Perform monthly preventative maintenance and calibrations on laboratory equipment
• Assists in the proof of concept studies, feasibility studies, and manufacturing using CritiTech’s Supercritical Precipitation equipment
• Assists in the proof of concept studies, feasibility studies, and manufacturing using CritiTech’s spray drying equipment
• Manage hazardous waste disposal. Serve as primary contact with waste disposal company.
• Manage gas cylinder inventory and deliveries
• Manage incoming materials and safety information. Conduct safety assessments of incoming materials
• Conduct inventory assessments and purchase general laboratory supplies to stock laboratory
• Maintain ISO7 clean room in state of readiness and perform weekly environmental monitoring.
• Serve as primary contact for shipping and receiving activities
• Assist site support services with facility maintenance as needed.
• Performs duties in compliance with FDA current Good Manufacturing Practices
• Other duties as assigned.
• High School Diploma or equivalent
• Experience in working with people in a multi-disciplinary team environment

EDUCATION & EXPERIENCE

Required

KNOWLEDGE & SKILLS

• Mechanical skills with tools and equipment
• Analytical and Problem-Solving Skills - ability to identify problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
• Teamwork - ability to work well in a highly cross-functional team environment
• Communication Skills – ability to express one’s self clearly and concisely to CritiTech personnel over the phone or with others within the team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience
• Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
• Knowledge Sharing – ability to capture knowledge within the organization; improves solutions, processes and deliverables through the use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use.
• Resource Management – ability to work with internal and external resources and to coordinate individual goals and objectives to align with business imperatives.
• Ability to lift and move 50 lbs
• Ability to work independently with minimal supervision

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