BIOPHARMA MANUFACTURING TECHNICIAN

Descrição: We are   now recruiting Biopharma Manufacturing Technician for a healthcare company with a large activity scope.As a Manufacturing Technician, 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 (1) Manufacturing, (2) Process Development, (3) Biologic Drug Product commercial support, and (4) New Product Introduction/Project Management. 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. Flexibility around shifts will be required.O que terás de fazer- 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.O que precisas de garantir- Bachelor’s degree is required in chemistry, pharmacy, engineering, or a related scientific field; an advanced degree is preferred;- 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.O que te proporcionamos- Possibility of growth in a leading company;- Competitive salary and benefits package, including opportunities for professional development and advancement;- Health Insurance for you and your family;- Life insurance;- Pension;- Education Assistance.