PE Global are currently recruiting for a Senior Manager -Tech Transfer based in Munster.
The successful candidate will be a Qualified Pharmaceutical Scientist/Engineer with Process Development, Technology Transfer and Inhalations experience. MDI exeperience is a must have.
The Role:
- Manage the site technical transfer operations.
- Execute Scale-up and Technology Transfer of Metered dose and dry powder inhalers in conjunction with Product Development group and Commercial Manufacturing.
- Understand DPI/MDI device design, associated ISO and CFR 820 regulations of combination device, functionality and manufacturing aspects.
- Manage & execute the design and develop robust manufacturing processes in support of active inhaler technology including: authoring experimental protocols, writing work instructions, batch records, and technical reports.
- Drive & promote cross functional project teams to support R&D operations and assist in the technical transfer of manufacturing activities from development to clinical/commercial manufacturing sites (both internal and external) including collaboration on manufacturing process development, batch records, material specifications, and oversight of manufacturing activities at external vendors.
Qualifications & Requirements:
- MS in Industrial Technology, Chemical Engineering, or Pharmaceuticals Sciences preferred
- Minimum 5+ years’ experience with pharmaceutical processing.
- Excellent Communication skills, Project Management experience and strong execution background.
- Problem solving and creativity are critical skills in this role.
- Experience with drug development necessary.
- Demonstrated knowledge of cGMPs as they apply to controlled pharmaceutical environments as well as working knowledge of FDA and international regulatory guidelines for process and manufacturing development is necessary.
- Direct experience with operation of aerosol manufacturing equipment is highly desirable.
- Demonstrated expertise in pressure filled MDIs and/or blister/capsule manufacturing process analytical technology and process improvement preferred.
- Understanding of Quality by Design concept and its application to pharmaceutical manufacturing is important.
If you are interested in this role please email CV to aoife.lomasney@peglobal.net or contact Aoife Lomasney on 0214297900.
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.
