Manager, Warehouse & Logistics

Startup Operations Phase

• Execute and manage all day-to-day warehouse activities including receiving, sampling coordination, storage, inventory management, and shipping of raw materials, consumables, intermediates, and finished products.
• Ensure strict adherence to GMP, DEA, FDA, and DSCSA compliance requirements from the outset.
• Create and implement SOPs, Work Instructions, and training documentation in accordance with ICH Q7 Section 10 and internal QMS.
• Operate SAP (WM/IM/MM) to perform and document material movements and status changes.
• Handle hazardous materials per regulatory requirements.
• Establish secure material segregation zones (ambient, refrigerated, flammable, DEA/cage).

Transition to Leadership & Strategic Oversight

• Recruit, train, and lead a high-performing warehouse team including material handlers, inventory control specialists, transportation, and shipping/receiving coordinators.
• Establish KPIs and performance metrics for inventory accuracy, order fulfillment, on-time shipments, safety, and cost efficiency.
• Oversee the development and execution of warehouse layout planning, material flow, space optimization, and process improvement initiatives (e.g., Lean/Kaizen).
• Lead internal audits and support external inspections from regulatory authorities.
• Collaborate cross-functionally with Quality, Manufacturing, Planning, Procurement, and Regulatory Affairs to ensure seamless material flow and data integrity.
• Drive continuous improvement in safety practices, documentation accuracy, and operational performance.

Required Qualifications

• Bachelor’s degree in Supply Chain, Operations, Business, or related field preferred. Associate’s degree with relevant experience considered.
• 5–8+ years of warehouse experience in a regulated pharmaceutical or biotech GMP environment.
• 2–3+ years of experience in a supervisory or management role with demonstrated team-building ability.
• Direct experience managing cold chain logistics, hazardous materials, and DEA-controlled substances.
• Advanced user of SAP (especially WM/IM/MM modules) and strong proficiency in Excel and inventory analytics.
• Strong knowledge of GMP, ICH Q7/Q10, DSCSA, and 21 CFR Part 1301.
• Proven ability to write SOPs and execute warehouse compliance documentation.

Key Competencies

• Strategic thinker with operational agility and startup mentality.
• Capable of working independently and scaling toward team leadership.
• Attention to detail, documentation accuracy, and audit readiness.
• Strong interpersonal and communication skills across all organizational levels.
• Ability to drive a culture of safety, compliance, and continuous improvement.

Physical and Work Environment Requirements

• Must be able to lift up to 45 lbs (assisted as needed for >45 lbs).
• Regular walking, bending, lifting, and use of warehouse equipment.
• Work in ambient and refrigerated environments as needed.
• Use of RF scanners, pallet jacks, forklifts (certification preferred), and computers.