Technical Writer

Manufacturing Specialist

Position 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:

• 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, nonconformances, and quality issues.
• Work close with Quality and Manufacturing teams to ensure documentation supports data integrity & good documentation practices (GDP) in compliance 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.

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.