DSP Manufacturing Technician – Level III
A fantastic opportunity for a Biologics Manufacturing Technician with Downstream Processing experience to work for a global biotech based in the Nordics. The ideal candidate will have biologics experience.
- Be able to work in accordance with cGMP and EHS practices, 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 protein products by operating column chromatography and filtration
- 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 an 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 (PAls), 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.
EDUCATION AND EXPERIENCE
- Degree in related discipline or sufficient relevant professional experience.
- Knowledge/experience of protein purification for production of monoclonal antibodies and recombinant protein therapeutic products.
- Hands-on experience operating downstream processing equipment
- Experience of protein purification principles, techniques, scale-up, technology transfer and process validation activities.
- Knowledge/experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
- Knowledge of cGMP compliance and associated documentation
- Minimum of 5 years in biopharmaceuticals or technical field is desired.
Proven experience of coaching and mentoring