Manager of Packaging

Manager of Device Assembly & Packaging Summary

The Manager of Device Assembly & Packaging holds strategic and operational accountability for INCOG's device assembly and packaging (DAP) program, overseeing 24/7 DAP operations across all production shifts at the Fishers, Indiana facility. This role directly leads three Packaging Supervisors — one per shift — ensuring continuity, consistency, and compliance across all activities involving device assembly and packaging activities of vials, syringes, and cartridges.

The Manager is the programmatic owner of DAP qualification, yield metrics, and regulatory readiness for the IDAP assembly and packaging function. This position is a critical quality and operational steward, interfacing across Quality, Manufacturing, and Regulatory Affairs to ensure the DAP program meets current GMP requirements and supports INCOG's growth as a world‑class sterile injectable CDMO.

• Develop and execute the long-term vision and strategic roadmap for INCOG's DAP program, aligning capabilities with organizational growth, regulatory expectations, and client commitments.
• Establish, monitor, and report on key performance indicators (KPIs) and quality metrics for the DAP function.
• Focused on packaging technology advancement, including evaluation, implementation, and validation of automated packaging systems.
• Drive Lean and Six Sigma continuous improvement initiatives across DAP operations, reducing waste, improving throughput, and driving a high quality standard.
• Represent the DAP function in site leadership forums, client meetings, and project teams, providing expert input on strategy, capacity, and program design for new product introductions.

• Directly lead three Packaging Supervisors across first, second, and third production shifts, providing day-to-day operational direction, performance oversight, and escalation support.
• Oversee 24/7 DAP operations to ensure seamless production continuity, consistent quality, and timely lot release readiness across all shifts.
• Develop and maintain DAP capacity plans and scheduling frameworks that align operator staffing with production demand, campaign schedules, and client commitments.
• Establish structured shift handoff protocols and communication rhythms to ensure operational continuity, accurate information transfer, and rapid escalation of quality or production issues between shifts.
• Manage the DAP departmental budget, including staffing, consumables, equipment maintenance, and capital planning for packaging and assembly technology investments.
• Serve as the primary escalation point for DAP-related production disruptions, non-conformances, and real-time quality events, coordinating cross‑functional response as needed.

• Ensure all DAP operations are conducted in full compliance with current Good Manufacturing Practice (cGMP) regulations, site SOPs, product specifications, and applicable regulatory guidance.
• Serve as a Subject Matter Expert (SME) for regulatory agency inspections — including FDA and EMA — preparing inspection‑readiness documentation and representing the program during regulatory site visits.
• Author, review, and approve SOPs, batch records, specifications, and qualification protocols governing all aspects of the DAP program.
• Lead deviation investigations and CAPA development for DAP‑related non-conformances, ensuring root cause analyses are thorough, timely, and supported by data.
• Maintain active cross‑functional partnerships with Quality Assurance, Quality Control, and Regulatory Affairs to support batch disposition, regulatory submissions, and site inspection readiness.
• Maintain and apply current knowledge of evolving FDA, EMA, and global regulatory standards governing the manufacturing, packaging, labeling and storage of finished medical devices, incorporating regulatory updates into program design and SOP revisions.

• Recruit, develop, and retain a high-performing team of Packaging Supervisors and front‑line packaging personnel, building organizational capability…