Job Details
**Warehouse Lead - Sr Manager**
at Beam Therapeutics RTP, NC **Company Overview**
Beam Therapeutics, launched in 2018, is pioneering the use of CRISPR base editing to develop a broad portfolio of advanced genetic medicines. Our groundbreaking base editing technology allows us to make permanent, specific edits to single bases in DNA and RNA, without cutting the strands. Base editor therapeutics represent a new class of precision genetic medicines, combining precision targeting of the genome with precision control of editing outcomes.
Our dream is to provide life-long cures for patients suffering from serious diseases.
The Beam Team Is:
* A community of fearless innovators
* Rigorous and honest in our research
* Listening with open minds
* Committed to each other
**Position Overview**
Beam is looking for an exceptional Warehouse Operations leader for our internal manufacturing site (under construction) in Raleigh-Durham North Carolina, to lead warehouse detailed design, commissioning and qualification activities, and building a team to operate the cGMP warehouse. The role will partner with IT on implementing Inventory and Warehouse Management System. You will perform warehouse and logistics operations to support clinical and commercial production of cell and gene therapy products including shipping, receiving, inspecting, storing, issuing, and delivering a variety of materials, equipment, and supplies within a cGMP warehouse. This role will be our Leader on the warehouse floor, overseeing the day-to-day Materials Management activity.
The ideal candidate will have a demonstrated track record of working in a dynamic environment. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross functional relationships.
**Responsibilities**:
* Support mfg site start-up, warehouse detail design, commissioning and qualification, temperature mapping activities, including authoring of standard operating procedures.
* Partner with IT on Inventory / Warehouse management system implementation, including business requirements, testing and training.
* Hire, coach, train, develop and manage performance of warehouse staff. Provide leadership to the team to attain site objectives for safety, quality, delivery, cost, and people.
* Responsible for ensuring employees are trained on SOPs, equipment, all unit operations and systems.
* Manage cGMP inventory for raw materials, consumables, critical materials including IMS/WMS/MRP system transactions. Manage the transfer of raw materials, consumables, etc. between on-site and off-site warehouse locations.
* Ensure robust inventory management controls are developed and maintained including cycle counts, waste disposal and temperature integrity for cold chain materials/products.
* Maintain the material warehouse, receiving and shipping docks in an inspection-ready state.
* Accountable for ensuring warehouse operations supports mfg schedule execution, including kitting and staging of materials.
* Solid understanding of the regulations of agencies such as the FDA, OSHA, and EPA. Act as SME, lead warehouse audits from regulatory inspection agencies.
* Identifies, communicates, addresses and improves cGMP compliance and regulatory gaps and issues. Champions continuous improvement ideas, leads development and deployment of strategies using RCA, Lean-6 sigma type methodologies.
* Develop, review and approve SOPs, lead deviation investigations, CAPAs and associated change controls for warehouse and inventory management.
* May be occasionally required to work shifts, holidays and weekends.
* Other duties as assigned.
**Qualifications**:
* Minimum 7+ years experience in warehouse management, logistics, and inventory management; preferably in the pharmaceutical/biotech industry.
* Strong computer skills including IMS/WMS/MRP software experience.
* Proficient in operating in a cGMP environment and adhering to cGMP guidelines.
* High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
* Ability to think critically, and demonstrate troubleshooting and problem-solving skills.
* Excellent attention-to-detail, interpersonal, verbal and written communication skills.
**Physical Requirements:**
* Must be able to work in Warehouse setting with variable noise levels, various hazardous materials like chemicals, reagents etc.
* Must be able to wear appropriate PPE, work in variable temperatures including cold rooms.
* Ability to operate forklifts and pallet jacks.
* Clarity of vision and have the ability to identify and distinguish colors.
* Must be able to perform activities with repetitive motions.
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