Upstream Manufacturing Lead - Biotech

Proclinical 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.

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.