Blackfield Associates are supporting a leading biopharmaceutical manufacturing organisation, who are looking for a motivated, detail-driven MSAT Technical Associate to join their Manufacturing Science and Technology (MSAT) team. In this hands-on role, you’ll support process validation and Continued Process Verification (CPV) for cutting-edge cell and gene therapy manufacturing.
Working closely with Process Development, Manufacturing, Quality Assurance, and Quality Control, you’ll help ensure processes are robust, compliant, and consistently delivering high-quality products.
What You’ll Do
* Serve as a Subject Matter Expert (SME), providing technical and scientific support for manufacturing processes.
* Support technology transfer and routine manufacturing with on-the-floor and on-call assistance.
* Perform root cause analysis, product impact assessments, and implement corrective/preventive actions.
* Contribute to risk assessments, process control strategies, and commercial readiness activities.
* Review manufacturing documentation, sampling plans, and material specifications.
* Support evaluation and GMP implementation of new equipment and materials.
* Assist with process improvements, change control activities, and data analysis for CPV.
* Represent MSAT in cross-functional projects and teams.
* Participate in technology transfer of new products into GMP manufacturing.
What We’re Looking For
Essential:
* 2–5 years’ experience in GMP manufacturing.
* Strong understanding of Good Manufacturing Practices.
* Excellent technical writing, problem-solving, and cross-functional collaboration skills.
* Ability to make data-driven decisions in a fast-paced environment.
Preferred:
* Experience in Advanced Therapy Medicinal Product (ATMP) manufacturing.
* Background in technology transfer, lifecycle management, and process improvements.
* Knowledge of regulatory policies, Quality Management Systems, Lean/Six Sigma principles.
* Hands-on experience with aseptic processing, cell culture, and downstream processing.
* Familiarity with data analysis tools, automation projects, and operational excellence initiatives.
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