Proclinical is partnering with a biotech company to recruit a Downstream Manufacturing Lead for a permanent, full-time position based in Iceland. This role comes with comprehensive relocation support. The primary focus is on overseeing downstream processes in a biotech manufacturing environment, with a strong emphasis on compliance, process optimization, and cross-functional collaboration.
General Responsibilities:Responsible for managing assigned tasks and maintaining a full end-to-end understanding of processes.Leads or actively contributes to projects and shop floor decision-making.Operates independently within established processes and standards, proactively addressing decisions and challenges.Capable of adapting procedures and processes as needed, including in cross-functional projects.Makes decisions with financial impact.Possesses specialized technical or administrative knowledge, with a deep understanding of relevant procedures.Often serves as an advisor to colleagues and team members.Works across teams and departments, with a primary focus on interdepartmental collaboration. Specific Responsibilities:Adhere to cGMP and EHS standards, performing all tasks safely and compliantly, and willing to take on extra responsibilities with minimal supervision.Ensure the DSP suite and equipment are consistently maintained in an inspection-ready state.Conduct cGMP activities in Grade CNC, D, and C environments.Prepare media and buffers according to specifications outlined in written protocols.Serve as a Subject Matter Expert (SME), authoring, reviewing, and approving SOPs, MBRs, and other cGMP documentation in areas of expertise.Support the execution of technical and validation protocols.Act as an SME to author and review deviations related to DSP processes, helping to identify root causes and implement corrective actions (CAPAs).Participate in the technology transfer of processes to manufacturing scale.Oversee lab work to ensure compliance with cGMP.As a certified trainer, provide training, coaching, and mentorship, supporting the development of a skilled, multi-functional DSP team.Contribute to successful commercial Pre-Approval Inspections (PAIs), audits, and other interactions with regulatory agencies.Continuously seek process improvements and opportunities for waste reduction to maintain an efficient, flexible manufacturing facility.Act as a stand-in for the Team Lead when necessary. Requirements:Education: Bachelor's degree in a related field or equivalent relevant experience.Experience: Knowledge and practical experience with mammalian cell culture for monoclonal antibody and recombinant protein therapeutic production.Hands-on experience with downstream processing equipment.Familiarity with cell culture principles, techniques, scale-up, technology transfer, and process validation.At least 5 years of experience in the biopharmaceutical or technical field (preferred).Proven teamwork skills with the ability to lead collaboratively when needed.
If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com
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