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º¬Ðß²ÝÓ°Ôº 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

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.

º¬Ðß²ÝÓ°Ôº is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. º¬Ðß²ÝÓ°Ôº is acting as an Employment Agency in relation to this vacancy.