Proclinical is collaborating with a biotech company to recruit a Senior DSP for their team in Iceland. This position centers on downstream processing within a cGMP environment, with a focus on protein purification and production. The ideal candidate will be proactive, capable of working independently, and dedicated to upholding high standards of safety and compliance.

Responsibilities:

Conduct activities in accordance with cGMP and EHS practices.Perform cGMP activities in Grade CNC, D, and C areas.Train in purification activities from protein A chromatography to freeze operations.Provide subject matter expertise for DSP processing steps.Maintain DSP suite and equipment in a state of inspection readiness.Author, review, and approve written procedures, standard operating procedures, BMRs, and other cGMP documentation.Assist in the execution of technical and authentication protocols.Lead and coordinate investigations for deviations, identifying root causes and corrective actions.Ensure QMS records are managed within defined KPIs.Contribute to the technology transfer of processes to manufacturing scale.Supervise and ensure manufacturing activities comply with cGMP.Coach and mentor new team members.Support commercial Pre-Approval Inspections (PAIs) and audits.Collaborate with other departments and contribute to process improvements.

Key Skills and Requirements:

Degree in a related discipline or equivalent relevant experience.Knowledge and experience in downstream purification processes for monoclonal antibodies and recombinant protein therapeutic products.Hands-on experience with downstream processing equipment.Experience in purification techniques, scale-up, technology transfer, and process authentication.Proven experience in coaching and mentoring.Experience supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies such as the FDA and EMA.Expertise in cGMP compliance and associated documentation.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.