Downstream Processing Scientist-Purification-Iceland-£70-£80k- Manufacturing - Protein Purification - Scale Up
A growing bio-pharmaceutical company requires an experienced manufacturing technician to join its Downstream Processing team. You will be working in a state-of-the-art manufacturing facility with some of the best scientists in the industry. To join you will have to have had hands-on experience operating downstream processing equipment and experience of protein purification.
The role is based at their HQ in Reykjavik, Iceland and as such the salary is inflated to accommodate the increased living costs. Ideally they are seeking an experienced technician who can hit the ground running but still has potential to develop and grow within the business. This is not a management opportunity.
Key responsibilities and work assignments:
*Be able to work in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe manner. Willing to take on additional activities with little or no supervision.
*The individual will need to perform cGMP activities in Grade CNC, D and C areas.
*Aseptically purify monoclonal antibodies and recombinant protein products by operating column chromatography and filtration equipment.
*Prepare buffers to set specifications in accordance with approved procedures.
*Proactively ensure the DSP suite and equipment is maintained in a state of Inspection readiness at all times.
*Be a SME author/reviewer and/or approver for written procedures, SOPs, BMRs and other cGMP documentations in span of expertise.
*Assist in execution of technical and validation protocols.
*Take ownership of deviations: lead and coordinate investigations as required, to help identify root cause and appropriate corrective actions.
*Contribute towards Technology Transfer of processes to manufacturing scale.
*Supervise and ensure laboratory work is carried out according to cGMP.
*Coach and mentor new starters to contribute to achieving a multi-skilled and engaged DSP team.
*Contribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interactions with regulatory agencies.
*Actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.
*Continually identify process improvement to help create and maintain a lean, flexible and agile manufacturing facility.
*Demonstrate operational excellence within functional area of responsibilities.
*Adhere to the company etiquette in all matters of behaviour and manners.
oKnowledge/experience of protein purification for production of monoclonal antibodies and recombinant protein therapeutic products.
oHands-on experience operating downstream processing equipment.
oExperience of protein purification principles, techniques, scale up, technology transfer and process validation activities.
oPrior experience in biopharmaceuticals or technical field, desired.
oProven experience of coaching and mentoring others.
oExperience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
oExpertise of cGMP compliance and associated documentation.
You MUST be eligible to work in Iceland. Learn more
- Agency: Cranleigh Scientific
- Posted: 4th July 2017
- Expires: 1st August 2017
- Reference: BBBH4792