Bob Hartz

About Bob Hartz

I’ve spent 25 years in manufacturing, 21 of those in biologics, because I like building things that matter and leading teams that take pride in doing work the right way. Today, as Associate Director of Manufacturing Operations at Keenova, I oversee end‑to‑end biologics production: upstream, downstream, media/buffer prep, warehouse operations, and day‑to‑day cGMP execution.I’m hands‑on by default. I stay close to the floor, support troubleshooting, and make sure my team has what they need to hit the production plan safely and reliably. After more than a decade in leadership roles, I’ve learned that consistency, clarity, and engagement are what move a manufacturing organization forward, not slogans.My strengths:Turning strategic goals into real production outcomesLeading teams through scale‑up, tech transfer, and changeImproving processes, reducing variability, and strengthening cGMP disciplineBuilding teams that are confident, skilled, and invested in the missionUsing data and root‑cause thinking to fix issues quickly and prevent repeat problemsManaging budgets, cost centers, and capital with a practical, operations‑first mindsetI work closely with Quality, Supply Chain, Engineering, and R&D to keep the site inspection‑ready, aligned, and ahead of schedule changes. My goal at Keenova is straightforward: build a manufacturing organization that’s reliable, adaptable, and proud of the work it delivers to patients.

Experience

1. Senior Manager Vector Manufacturing (Bulk Drug Substance)

   SK pharmteco

   Jan 2024 — Present · King of Prussia, PA, US

   SENIOR MANAGER, BULK DRUG SUBSTANCE (Upstream, Downstream, Drug Product, Cell Banking)• Direct entire BDS team in execution of Vector manufacturing for multiple clients.• Forecast Staffing, Equipment, Material, and Budgetary Needs for Production• Review and approve documentation for IOQ, Operations, Execution, Procurement, Etc.• Oversee the development and execution of PPQ, Clinical, Startup and GMP activities through close collaboration with PD and MSAT.• Provide SME guidance and analysis for new technologies, equipment, processes, and tech transfers.• Floor plan development, including equipment purchasing, utility design, and process flow• Liaise w/ all departments on Organizational readiness.• Develop, communicate, and drive completion of manufacturing deliverables.• Lead process support and troubleshooting for all upstream activities.• Enable team to meet/exceed departmental and site safety and performance metrics.• Ensure production, safety, and quality standards are met throughout manufacturing.• Manage and approve staffing, scheduling, and shift rotations.• Lead deviation investigation, writing, and Capa development / Implementation.• Support team members’ development through performance-based feedback and guidance.• Evaluate training and cross-training across manufacturing to ensure site readiness and agile workforce.• Coordinate the interviewing and hiring of new and temporary employees.• Review and recommend performance-based disciplinary correctives for department• Project management for client specific processes implementation / execution• Member of site Safety Council and Site Chemical Hygiene Officer (CHO)

Education

• Albright College

  Bachelor of Science (BS), Business Administration and Management, General

  2011 — 2013