Downstream Biotechnology SME job in Reykjavík, Iceland

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Job type: Permanent

Discipline: Bioprocessing

Location: Iceland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Downstream Biotechnology SME to join a pharmaceutical organisation. This role is on a permanent basis and is located in Reykjavik.

Responsibilities:

Train new starters to partake in accomplishing a multi-skilled and interacted DSP team.
Get involved in tasks which include any other divisions within the organisation.
Conduct cGMP actions in Grade CNC, D, and C areas.
Monitor as well as guarantee manufacturing actions are carried out rendering to cGMP.
Recognise process improvement to assist with producing and preserving a lean, flexible, and agile manufacturing facility.
Offer subject matter expertise for DSP processing steps as and when necessary.
Guarantee QMS records are instigated, progressed and closed within the company outlined KPIs.
Serve as an SME write/evaluator and/or approver for written processes, SOPs, BMRs and any other cGMP documentations within the span of knowledge.
Partake in technology transfer of procedures to manufacturing scale.
Other duties to be assigned.

Key Skills and Requirements:

Educated to a degree level in a pertinent field or equivalent work experience.
Know-how of downstream purification procedures for production of monoclonal antibodies and recombinant protein therapeutic products.
Familiarity with operating downstream processing equipment.
Acquaintance with purification practices, scale up, technology transfer and process validation actions.
Demonstrable experience working within a biopharmaceuticals or technical field would be ideal.
Prior involvement in training others.
Former involvement in assisting with pre-approval inspections as well as working with global regulatory agencies which involves the FDA and EMA.
Knowledge of cGMP compliance and affiliated documentation.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at +44 203 987 6281.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#TechOps

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Salary

Highly Competitive Salary

Location:

Wrexham, Wales

Proclinical is seeking a Senior Principal Scientist to lead strategic projects in biomanufacturing processes, focusing on API/Drug substance processing.