Biopharma Manufacturing Technician

Description

Team Horizon is seeking a Biopharma Manufacturing Technician for our Clients Technical Operations team in Mayo. In this role you will be responsible for all manufacturing activities necessary to support a tech transfer of a NPI to accommodate clinical manufacture of small and large molecule products. Your new duties will involve Manufacturing, Process Development, Biologic Drug Product commercial support, and New Product Introduction/Project Management.

 

Why you should apply:

Great benefits, a defined career path, and work-life balance

As part of a team, you will be responsible for ensuring that drug product manufacturing is performed in compliance with site and GMP procedures, and that scheduling and manufacturing meets global request timelines.

 

What you will be doing:

Preparing equipment & components to allow for the aseptic filling, stoppering, freeze-drying and capping of Toxin products on the Vial Processing Line in Core 1.

Manufacturing of clinical, non-clinical and pre-clinical material.

Batch preparation activities (vial washing, load sterilization, area preparation

Compounding, sterile filtration and sterile filling

Work with various vendors on the development/improvement of new and existing systems regarding single use technologies.

Aid in running a multi-product suite, changing between different product campaigns without issue.

Support process development and technology transfer of products for clinical supply and successful regulatory approval of new product submissions

Provide strong scientific leadership for ongoing marketed commercial products providing technical support and expertise to troubleshoot and lead investigational enquiries where necessary.

Review and author technical documents, including protocols, reports, batch manufacturing documents and CMC sections of regulatory dossiers.

Participate in and lead cross-functional teams with other functions, including R&D, Engineering, Quality, Supply Chain, Operations and Validation

 

What you need to apply:

3rd level qualification in a technical/scientific discipline

 2+ years in the pharmaceutical or medical device industry is preferred.

Prior knowledge of aseptic practices in clean room environments is essential 

Strong knowledge of GMP regulatory guidelines, quality systems, drug product manufacturing and validation is essential.

Understanding of autoclave sterilization, depryogenation, and filter integrity testing is essential

Knowledge of lyophilization and freeze dryer operations is desirable. Experience with single use technologies is desirable.

Well-developed technical writing, organisational, and communication skills are essential.

Experience acting as an individual contributor and working well in project and team-based environments is essential.

Pro-active approach with proven problem-solving skills is desirable.

Experience with single use technologies is desirable.

Experience acting as an individual contributor and working well in project and team-based environments is essential.

Flexibility around shifts will be required.

 

 

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