Sr. Manager, Warehouse

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are in the midst of an incredible journey, and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Senior Warehouse Manager is responsible for leading, organizing, sustaining, and continuously improving the warehouse operations in support of the manufacturing operations at the plant. This individual will work in the warehouse and on the manufacturing floor to ensure materials 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.

Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training and ensure all members of the warehouse team are current in their training requirements as well as all applicable policies and procedures related to the job function. Provide direction in the warehouse to other staff members, resolve issues, escalate when necessary and provide leadership updates. The successful candidate will have accountability to ensure all documentation is complete and accurate, so any issues can be addressed real time.

Responsibilities

• Manage the day-to-day Warehouse operations and personnel, across 4 shifts, 24 hours per day x 7 days per week. Provide Warehousing support for 5 manufacturing areas including Medias and Buffers; Cell Expansion; iCellis; Purification; and Drug Product Fill-Finish, Inspection and Packaging.
• Plans and coordinates work, hires, trains, motivates, and monitors and evaluates performance of warehouse and receiving associates; develops supervisors to effectively oversee the daily responsibilities of their assigned team members.
• Drive warehouse processes and initiatives, proactively plans to avoid delays in the process, executing good documentation practices, and providing leadership and guidance for the warehouse team.
• Ensure materials are received, stored, delivered, and shipped in a safe, compliant and efficient manner.
• Support manufacturing operations with timely delivery of all required materials in adherence with the manufacturing schedule.
• Lead team responsible for dispensing and weighing out raw materials in appropriate amounts, ensuring GMP requirements are met, in support of manufacturing operations.
• Lead team responsible for kitting component and raw materials in appropriate amounts, ensuring GMP requirements are met, in support of manufacturing operations.
• Develops and recommends annual budget requirements for the warehouse and receiving department. Anticipates and requests funding for future personnel requirements. Anticipates and requests funding for future material handling equipment.
• Partners with Materials Planning to actively manage Warehouse capacity.
• Ensure compliance with federal, state, and local requirements for warehousing, material handling, and shipping by staying abreast of existing and new legislation.
• Lead or participate as an SME, in Regulatory audits, tours, or information requests for all FDA, other Agency, and internal audits of the warehouse/processes and respond to any observations received per procedure.
• Responsible for maintaining high quality standards to meet cGMPs and CFRs, ensure compliant documentation and training is current, and comply with all internal company policies directly related to the warehouse processes.
• Provide feedback and subject matter expertise on hazardous materials handling, storage and shipping.
• Proactively look for opportunities to implement operational excellence and continuous improvement initiatives.
• Support Director Supply Chain to meet information requirements as needed for quality, compliance, and management reporting.
• Assist the technical operations team in resolving any issues related to receiving, storage or shipping.
• Safeguard warehouse operations and contents by establishing and monitoring security procedures and protocols.
• Maintain and Monitor Inventory accuracy via physical counts, cycle counts, and reconciliations within the ERP system.
• Provide support for International Shipments as the SME for custom invoicing information.
• Participate in cross-functional continuous improvement and operational excellence projects to drive efficiency and eliminate waste in the process through mistake-proofing.

Qualifications

• B.S. degree in supply chain, engineering, science, business or related field, or equivalent years of experience.
• A minimum of 10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience receiving, shipping and warehousing.
• 5+ 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 3 rd parties (material suppliers, equipment suppliers, distribution centers, 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.
• Resolve all warehouse issues while driving towards issue preventions.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Approximately 10% travel required.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.