Associate Director, Fill/Finish Manufacturing at ZYLIDAC BIO LLC – Emeryville, California

The incumbent will direct/manage daily operations pertaining to all aspects of clinical and commercial fill/finish operations including process development, process optimization, technical document authoring, continuous improvement, process validation, continuous process verification, routine problem resolving, troubleshooting, and scheduling production. Subject matter expertise and experience in aseptic drug product filling, visual inspection, clinical/commercial labeling, and packaging are required.

This role will be the technical and leadership resource for fill-finish manufacturing to interface with RA, QA, QC, FAC, VAL, PD, SC, and drug substance production teams to ensure reliable, compliant, and efficient production of clinical and commercial biologics. This position will report to the Chief Manufacturing Officer and will be based in Emeryville, CA.

Manufacturing & Operations Leadership

• Lead daily fill-finish operations including aseptic filling, inspection, labeling, packaging, and serialization.
• Ensure cGMP compliance, documentation accuracy, and in-process/environmental monitoring.
• Develop production schedules and drive operational efficiency.
• Direct the work of fill-finish manufacturing personnel in the aseptic filling, visual inspection, product labeling, packaging, and serialization.
• Establish weekly production schedules to ensure orders and product specifications are met.
• Develop and establish efficient aseptic filling operation, including visual inspection
• Develop and establish efficient clinical and commercial labeling, packaging, and serialization operations

Equipment, Process Development & Technical Leadership

• Troubleshoot automated/semi-automated equipment
• Oversee equipment qualification/validation, PM, and calibration.
• Lead Fill/Finish process development, tech transfer, engineering runs, and process validation runs.
• Analyze process performance and implement improvements.
• Ensure reliable operation of all Fill/Finish manufacturing and support systems.

Process & Documentation

• Lead development of records, BOMs, SOPs, and GMP documents.
• Plan and manage new product and lifecycle launches including package design, packing configurations, label and artwork development, manufacturing, distribution, and all associated change controls.
• Manage serialization master data, processes, policies, and procedures ensuring compliance with regulatory requirements.

Quality Systems & Compliance

• Lead/support deviations, CAPAs, risk assessments, and change controls.
• Ensure compliance with FDA, EMA, JP, DSCSA, and global standards.
• Support regulatory submissions
• Support internal/external audits.
• Identify and implement process and equipment improvement opportunities; contribute to LEAN, 5S, and Six Sigma initiatives.
• Develop and provide hands-on and classroom training to team members.

• BS or MS Degree or higher in Engineering (preferred) or another scientific discipline.
• 8+ years directing/managing an aseptic filling operation (required) and Labeling/ Packaging/ Serialization for both clinical and commercial operation.
• Experience with troubleshooting semi-automated/automated systems
• Regulatory inspection experience preferred.

PREFERRED SKILLS:

• Comprehensive understanding of aseptic techniques, media fill qualifications, and contamination control strategies.
• Good proficiency in equipment control and automation processes for aseptic filling and labeling/ packaging/ serialization equipment.
• Good knowledge of package development and experience with commercial packaging operations and serialization requirements.
• Good knowledge and experience with DSCSA and labeling/packaging design.
• Good knowledge of FDA, EU, JP Monograph, and other health authority regulations
• Good understanding of regulatory site inspections for a commercial fill/finish facility
• Strong organizational and leadership skills.
• Proficiency with Microsoft Office; Experience with SAP or Oracle is a plus