J5614Capital Region - HöfuðborgarsvæðiPharmaceutical Biotechnology Science PermanentDependent on experienceFull Time14/05/2018Biochemistry Biochemistry – Fermentation / Upstream Processing Biochemistry - Expression Biochemistry – Purification Biochemistry – Development / Validation Biochemistry – Production / Manufacturing Cell Culture
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We are currently looking for a MSAT Project Leader to join an exciting and rapidly expanding Biosimilars company based in Iceland. As the MSAT Project Leader you will be responsible for the planning and delivery of activities and projects within the Manufacturing Science and Technology group.
The role is based full time in Reykjavik, the company are able to offer excellent salaries and a full relocation package.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the MSAT Project Leader will be varied however the key duties and responsibilities are as follows:
1. Lead Technology Transfer and facility fit of processes to manufacturing scale building and maintain process specific database for technology transfer, NPI and process ownership.
2. Continually identify and implement opportunities for process improvements to create a lean, flexible and agile manufacturing facility.
3. You will be an SME author/reviewer and/or approver for written procedures, SOPs, BMRs and other cGMP documentations in span of expertise.
4. Specification and implementation of new equipment and processes.
To be successful in your application to this exciting opportunity as the MSAT Project Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in Biotechnology, Biochemistry, Biochemical Engineering or similar along with industry experience in downstream processing ideally on a variety of scales.
2. Proven industry experience in biopharmaceutical scale-up and/or tech transfer into a GMP facility is essential.
3. A working knowledge and practical experience with supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA is highly desirable.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.