Manufacturing Specialist
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Job Detail
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Job Description
Job Summary
The Manufacturing Specialist is a key technical contributor responsible for process optimizations, manufacturing troubleshooting, continuous improvement initiatives to ensure Manufacturing consistently produces quality product. This role sits at the intersection of operational excellence, quality, training & development, and MSAT supporting efficient, compliant, and ever improving operations.
The ideal candidate will have a strong understanding of cGMP compliance, quality event investigation, lean production methodologies, and process technology to drive reliability in operations.
Key Responsibilities and Duties:Â
Process Improvement & Optimization
•   Identify and implement continuous improvement projects using Lean methodologies to improve and stabilize yield, efficiency, and process success. •   Partner with MS&T and Process Development to monitor process performance to identify data-driven solutions and enhancements.•   Support technology transfer, process scale-up, and process validation to ensure smooth transitions into manufacturing. •   Partner with MS&T and Engineering to optimize equipment utilization, automation strategies, and data analytics for real time adjustments and support.
Compliance & Manufacturing Support
•   Conduct timely batch record reviews and deviation investigations, ensuring long term resolution of documentation/instructional issues. •   Lead root cause analysis and corrective/preventive action (CAPA) for process deviations, non-conformances, and quality issues. •   Work close with Quality and Manufacturing teams to ensure documentation supports data integrity & good documentation practices (GDP) incompliance with FDA, EMA, guidelines.
Training and Documentation Management
•   Develop and maintain SOPs, training materials, and documentation systems for manufacturing compliance and process improvements. •   Partner with MS&T and Training to conduct training programs for manufacturing staff to ensure adherence to cGMP, process guidelines, and quality requirements. •   Work cross-functionally to ensure employees remain qualified and up to date on process and compliance expectations.
Job Qualifications
•   Bachelor’s degree in relevant Science or Engineering discipline preferred. •   Minimum 3 years working within industry. Strong technical writing capabilities a plus. •   Experience within cell/gene therapies, biologics, and/or cGMP regulated environment preferred•   Knowledge of process improvement and lean methodologies preferred. •   Ability to interpret and present complex scientific data in a clear and concise manner. •   Proficient in Microsoft office suite and document management systems. •   Strong organizational and project management skills.