Manager, Warehouse & Aph/FP - Cell Therapies
The Warehouse & Aph / FP Manager is responsible for leading, organizing, sustaining, and continuously improving the warehouse and the Apheresis / Final Pack operations in support of the manufacturing activities at the plant. This individual will work to ensure materials and products are received, stored, delivered, and shipped in a safe, compliant and efficient manner. This position will be responsible for all material handling and storage at the plant and the Apheresis receipt and the Final Pack shipments. About the Role
Responsibilities:
- Manage and lead the day-to-day Warehouse and APH/Pack team operations and personnel, across all shifts, 24 hours per day x 7 days per week.
- Support manufacturing operations with timely delivery of all required materials in accordance with the manufacturing schedule.
- Ensure cGMP documentation is filled out correctly, training for all team members is current, and all Quality requirements are being followed. Lead or participate in tours or information requests for all Regulatory and internal audits and respond to any observations received per procedure.
- Ensure that the teams are adhering to quality standards that comply with all cGMP requirements, CFR's, and internal company policies and SOPs, related to Warehouse and APH/Pack operations.
- Proactively looks for opportunities to implement operational excellence and continuous improvement.
- Partner with Quality and Safety to ensure a high quality,compliant and safe operation. Support Director Supply Chain to meet information requirements as needed for quality, compliance, and management reporting.
- Ensure compliance with federal, state, and local requirements for warehousing, material handling, and shipping by staying abreast of existing and new legislation.
- Ensure material availability by managing inventory accuracy and levels through physical counts and reconciling with ERP system.
- Plans and coordinates work schedules for personnel to ensure the proper staffing levels and shift structure is in place to support processes across all shifts for the Warehouse and APH/Pack teams.
- Responsible for hiring, training, and evaluating the performance of Associates, and for developing supervisors to effectively oversee the daily responsibilities of their assigned team members.
- Ensures the teams achieve Operational targets for Quality, Safety and Cost efficiency
- B.S. degree in supply chain, engineering, science, business or related field.
- A minimum of 3-5 years of experience in biopharmaceutical based GMP manufacturing operation including direct experience receiving, shipping and warehousing.
- 1-3+ years of supervisory experience with demonstrated effectiveness in providing input, guidance, mentorship and support to staff.
- Working knowledge of FDA regulations and cGMP practices.
- Excellent oral and written communication skills with strong technical writing ability required.
- Ability to motivate staff and influence peers, foster a culture of continuous improvement and operational excellence.
- Experience with 3rd parties (material suppliers, equipment suppliers, contract manufacturing partners, etc.).
- Project management skill set with experience in strategic/tactical planning, team building, and overall budget requirements. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
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