SENIOR BIOTECHNOLOGIST. Höfuðborgarsvæði. Islandia

SENIOR BIOTECHNOLOGIST for Alvotech

Key responsibilities:

• 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 only moderate supervision.

• The individual will need to perform cGMP activities in Grade CNC, and D areas.

• Get trained in purification activities from protein A chromatography until end of production process in freeze operations with the relevant protocols and batch records.

• Proactively ensure the DSP suite and equipment is maintained in a state of Inspection readiness at all times.

Competencies required to fulfil the employee responsibilities and work assignments:

• 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.

• Contribute to investigations as required, to help identify root cause and appropriate corrective actions.

• Supervise and ensure manufacturing activities are 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.

Specifics of the role:

• 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 funtional area of responsibilities.

• Assist in execution of adhoc tasks assigned by supervisor to support manufacturing activities.

Adhere to the company etiquette in all matters of behaviour and manners.

Minimum education and experience required for the role:

o Degree in related discipline or sufficient relevant experience.

o Knowledge/experience of downstream purification for production of monoclonal antibodies and recombinant protein therapeutic products.

o Hands-on experience operating Downstream processing equipment.

o Knowledge/experience of cell purification techniques, scale up, technology transfer and process validation activities.

o A minimum of 3 years in biopharmaceuticals or techincal field, desired.

o Proven experience of collaborative team-working, leading when appropriate.

o Knowledge/experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.

o Knowledge of cGMP compliance and associated documentation

The work hours are three shifts operating 24/7.

The shifts are:

•    08:00 - 16:30

•    16:00 - 00:30

•    00:00 - 08:30

Wages according to collective agreements in Iceland with relevant unions.

Employer can assist with housing

Please apply by filling in an online application here: https://form.vinnumalastofnun.is/eures and put "250214-04 in the field for employer.

Last application date is March 14th, 2025.