MANUFACTURING SPECIALIST

Job Description

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

• 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 closely 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.

Pay

Pay ranges between 20-30/hr based on experience

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally.

Fraud Alert

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