Downstream Associate (Level 2 / Level 3) - Iceland
Naynesh Mistry at CK Science is currently recruiting for Downstream Associates (Level 2/Level 3) to join a leading Biopharmaceutical company based in Iceland on a permanent basis.
Summary: To set up and operate production equipment and processes in the Downstream Processing Suite to produce monoclonal antibodies and recombinant protein products in a safe and cGMP/regulatory compliant manner, to meet or exceed project and/or manufacturing expectations and targets.
As a Downstream Associate (Level 2/Level 3) you will:
- Build, clean and sterilise equipment and prepare sterile reagents in compliance with appropriate MIR's, SOP's and Work Instructions, completing log books as appropriate.
- Aseptically generate monoclonal antibodies and recombinant protein products by operating column chromatography and continuous filtration (TFF, UF, DF, MF, etc.) equipment.
- Support the maintenance of a compliant facility by, for example, WFI and environmental monitoring sampling and responding appropriately to FMS alarms.
- (LEVEL 3) As a Trained Trainer, train, coach and mentor others to contribute to achieving a highly, multi-skilled and engaged DSP team.
- (LEVEL 3) Proactively highlight to Team Leader any issues of concern, whether they be plant, process, people or performance.
- Determine equipment requirements via User Requirement Specifications and take part in Qualification and Validation activities e.g. FAT/SAT, IQ, OQ, PQ and PV as required to assist adherence to manufacturing strategy milestones.
- (LEVEL 3) Author, draft, amend and review operating documents i.e. SOP's BMRs, Validation Reports, Training Packages, Material Requirement Specifications and other cGMP documentation.
The successful Downstream Associates (Level 2/Level 3) will have the following qualifications, skills and experiences:
- BSc in biotechnology, chemistry, bio/chemical engineering or comparable
- Solid scientific and manufacturing knowledge of running downstream purification studies, process validation, and process characterisation of monoclonal antibody and recombinant protein therapeutic products
- Hands-on expertise operating downstream processing equipment including continuous filtrations (TFF, UF, DF, MF, etc.) and column chromatography.
- Experience of scale-up, technology transfer and process validation activities.
- Experience in Biopharmaceuticals
- Proven experience coaching and mentoring others.
- Practical experience of URS, FAT, SAT, IQ, OQ, PQ
- Experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
- Expertise working with up-to-date cGMP compliance and associated documentation.
If successful you will be joining a leading Biopharmaceutical company based in Iceland with excellent benefits.
To apply for this Downstream Associates (Level 2/Level 3) position contact Naynesh Mistry via email: firstname.lastname@example.org or telephone: 01246 457 703 or please click on the link below.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH33244 in all correspondence.