The Head of Sterile Manufacturing will join a highly skilled, dynamic leadership team, with a very attractive salary & comprehensive benefits package in a career defining role to grow develop an aseptic compounding unit as part of ambitious growth project
- Advanced knowledge & experience in aseptic technique and clean room operations.
- Previous experience of Aseptic manufacture - Lab scale and/or Specials, small batch.
- Proficient understanding of all standards and requirements relevant to Clean Room operation and compounding (GMP/ISO).
- Ability to work independently and in a team setting.
- Advise on equipment requirements - Sterilizers, autoclaves & process equipment.
- Hands-on aseptic process design and manufacture - Lab scale for ophthalmic preparations and injectables.
- Ability to supervise and train Aseptic personnel as the business grows, providing guidance and support whilst reporting to the Senior Production Manager.
- Develop and maintain facility environmental monitoring program.
- Must be hands-on.
- Create appropriate change controls and deviations.
- Development and updating of Standard Operating Procedures and master formulas as required.
- To create and maintain validation documentation
- Verify the chemical and in process checks, including all mathematical calculations and documentation.
- Assist with prioritizing the daily and weekly tasks appropriately
- Complete the area checklist inspection on a daily basis or as necessary.
- Maintain and monitor the cleanliness of the area by following the environment monitoring and cleaning schedules.
- Assist with the monitoring of inventory items
- Liaise with other departments, as needed.
- Excellent communication skills.
- Superb attention to detail.
- Mathematical and problem-solving skills.
- Able to effectively prioritize and multi-task.
- Willingness to learn in a constantly changing environment.
- Position requires Bachelor's-Degree in pharmacy or related science or technical field.
Please contact Liam Smith at Science Solutions for more information.