Passage Bio is an exciting, fast-paced, rapidly growing gene therapy company headquartered in Philadelphia, PA. Our portfolio of rare monogenic CNS gene therapies is the result of an exclusive collaboration with the renowned Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) that provided Passage Bio with 17 gene therapy candidates developed in the lab of gene therapy pioneer Dr. James Wilson. Passage Bio is on a mission to provide life-transforming gene therapies for patients with rare monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.
This position will be responsible for implementing and executing the day-to-day operations of a GMP Warehouse.
Reporting to Joel Kunkle, Lab Services Manager.
Here Is What You Will Be Doing:
· Oversee and coordinate daily warehouse activities including, but not limited to receiving and storing of sensitive and general use goods, management of inventory levels, ensuring the safe receipt and delivery of goods, and maintaining and securing the warehouse at all times
· Responsible for all aspects of materials management functions of the GMP warehouse (internal and external).
· Responsible for Inventory/Raw Materials Management.
· Advise management on GMP/GLP operations and best practices including notable variations to/within current state.
· Oversite of warehouse operators and/or contract employees
· Maintain a culture of safety within the overall lab environment
· Ensure materials, supplies and miscellaneous receipts are received, processed, documented, and maintained in accordance with SOPs, including the handling of temperature sensitive and hazardous materials.
· Responsible for continuous fulfilment of inventory and Kanban requests as flows and demands fluctuate
· Establish and adjust minimum stock quantities/reorder points.
· Maintain ambient & cold storage records & organization.
· Receive and respond to warehouse owned equipment alarms (24/7/365) and move material as needed to an equivalent location and document per procedure.
· Adhere to all OSHA and regulatory warehouse requirements.
· Ensure daily warehousing operations including staging, cycle count, receiving, storage, quarantine, and release of materials per SOP are compliantly executed.
· Identify and implement warehouse improvements based on evidence-based needs and opportunities
· Support implementation of Warehouse management system, improvements, and upgrades related to warehouse operations.
· Work closely and effectively with Supply Planners, Shipping and Receiving, Facilities, Procurement, and Quality Assurance teams to ensure uninterrupted manufacturing operations.
· Track and report warehouse operations through metrics and key process indicators (KPIs).
· Work closely with QA to author, edit, and/or review documents and procedures.
· Perform deviation investigations and CAPAs when necessary.
- Overseeing/Perform manual and automate cycle counts, including quality checks.
- Support/lead operational excellence initiatives.
- Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination required.
Here Is What You Will Bring To The Table:
· Must be familiar with SOPs and cGMPs procedures.
· Must have 5+ years’ GMP Warehouse Operations experience.
· Must have 5+ years’ experience with shipping/receiving packages using FedEx/UPS and other carriers domestically and internationally in accordance with IATA standards and guidelines.
· Transportation of Hazardous Materials (Certification: IATA and 49CFR).
· Must have 3+ years of computer inventory experience and familiar with purchasing.
· Must be hands on with shipping/receiving.
· 2+ years of Supervisory experience.
Passage Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Passage Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.