An exciting opportunity has arisen for Manufacturing manager within a start-up pharmaceutical biologics facility in Dublin. Can you lead a team and provide expertise in drug commercialization & manufacturing? Then this is for you!
Would you like to customize how you want to run the plant from scratch? Well, here you can! This startup facility is under the final stages of construction and your job will involve setting up the framework for the operations of the manufacturing facility.
The Product in this Job
First, of its kind, the exciting product which will be manufactured at this GMP site will be used to treat Chron's disease and is made up of mesenchymal stem cells. Once injected into the patient's colon these will facilitate regeneration of what was inflamed and damaged tissue.
- Lead Technical Transfer for this regenerative injectable product.
- Support the operation of this aseptic manufacturing facility
- Liaise with cross-functional teams of QC, QA, CAPEX, Logistical teams to adhere to operational schedules.
- Ensure compliance with regulatory requires of EMEA certified, GMP-facility based drug production.
- lead process validation teams.
- Ensure that the plant operates at maximal capacity and efficiency
- Regulate and complete, where necessary specific documents like Batch Manufacturing Records, SOPs, Tech-Transfer and EOP documents.
- Lead production operations including the aseptic manufacturing, filling & packaging.
- Represent the site in the global team of the business.
- respond to and manage escalations with respect to any problems on site.
Ideal Candidate for the Job
- You must have Aseptic Manufacturing and drug commercialization experience.
- GMP Pharmaceutical experience.
- Leadership skills - with demonstrated team management positions in your career.
- Bioprocessing experience is a distinct advantage.
- Cell culture experience is a distinct advantage.
- Regenerative research experience is a distinct advantage.
If you feel that you are up for the challenge of this novel-drug based job then contact in confidence Andrius at 01 4744 692, or email to firstname.lastname@example.org or indeed apply below.
Executive salary and attractive package as well as an ability to be at the forefront of this drug's release!
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