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���߲�ӰԺ is seeking an Upstream Manufacturing Lead for a biotech role in the Nordics. This position focuses on overseeing upstream manufacturing processes, ensuring compliance with cGMP and EHS standards, and contributing to cross-functional projects. Comprehensive relocation support is available.

General Responsibilities:

• Responsible for completing assigned tasks and overseeing the entire process from start to finish.
• Leads or actively participates in projects and decision-making on the shop floor.
• Works independently within set processes and standards, taking a proactive approach to problem-solving.
• Capable of making procedural adjustments and contributing to cross-functional projects.
• Makes decisions that impact finances.
• Possesses expert technical or administrative knowledge along with relevant procedural expertise.
• Provides advisory support to colleagues and peers.
• Works across teams or departments, with a primary focus within and between groups.

Specific Responsibilities:

• Work according to cGMP and EHS standards, carrying out tasks in a compliant and safe manner; willing to take on additional responsibilities with minimal supervision.
• Ensure the USP suite and equipment remain in a constant state of readiness for inspection.
• Perform cGMP activities in Grade D and C environments.
• Prepare media and buffers to defined specifications, following written protocols.
• Serve as an SME to author, review, and approve SOPs, MBRs, and other cGMP documentation within their area of expertise.
• Support the execution of technical and validation protocols.
• Act as an SME to author and review USP-related deviations, helping to identify root causes and implement suitable CAPAs.
• Contribute to the technology transfer of processes to manufacturing scale.
• Supervise lab activities to ensure cGMP compliance.
• As a certified trainer, provide coaching, mentoring, and guidance to support the development of a skilled and engaged USP team.
• Contribute to the success of commercial Pre-Approval Inspections (PAIs), audits, and interactions with regulatory agencies.
• Continuously seek process improvements and waste reduction opportunities to maintain a lean, adaptable manufacturing environment.
• Serve as a deputy for the Team Lead when necessary.

Requirements:

• Education: Bachelor's degree in a relevant field or substantial relevant experience.
• Experience: Knowledge and hands-on experience with mammalian cell culture for monoclonal antibody and recombinant protein therapeutic production.
• Direct experience operating upstream processing equipment.
• Familiarity with cell culture principles, techniques, scale-up, technology transfer, and process validation.
• Minimum of 5 years' experience in the biopharmaceutical or technical field (preferred).

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.

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