Patient Cell Handling, Warehouse Associate II

The individual for this role is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors and autologous cell therapies. This role works closely with Manufacturing Operations, Quality Control, Quality Assurance, and Supply Chain to establish warehouse operations and all necessary procedures, processes, and systems.

KEY ROLE AND RESPONSIBILITIES:

Patient Cell Handling:

• Book and monitor shipments including but not limited to evaluating flight options, monitoring weather, monitoring shipment temperature and location, and communicating with courier service.
• React to any issues in scheduling and logistics with urgency and triage to the appropriate teams to resolve, this may include outside of normal business hours.
• On a rotating basis, support the 24/7 on-call support for the patient cell scheduling team by reacting to phone calls and emails outside of normal business hours during the on-call period.
• Responsible for meeting the courier for patient cell collection receipt and drug product shipment at the Lyell manufacturing plant and recording the inventory transfer in Lyell’s ERP system.
• Monitoring collection kit inventory and facilitate the shipment of collection kits to the clinical sites when needed.
• Help establish and maintain electronic tools, processes, and procedures to support the patient cell handling space.

Warehouse Operations:

• Coordinate, receive, and organize daily deliveries of start-up equipment and supplies to be ready to move into the facility and/or warehouse.
• Assist with the development and implementation of GMP procedures, policies, and processes related to warehouse operations.
• Support manufacturing, warehousing, inventory control, and distribution activities for the Bothell facility in accordance with GMP regulations and related SOPs.
• Receive and appropriately sort, document, label, and store incoming deliveries.
• Update and maintain inventory control system.
• Perform warehouse operations safely, as scheduled, and right the first time to ensure delivery of treatment to patients.
• Maintain the warehouse at a high standard of cleanliness and organization.
• Perform equipment maintenance and calibrations as required.
• Complete and review GMP documentation in a timely manner.
• Maintain appropriate level of training for assigned responsibilities.
• Performs physical cycle counts, reconciling with data storage system.

Skills

• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management), inventory management systems (e.g. ERP), and building / equipment management systems. KNOWLEDGE, SKILLS AND ABILITIES:
• Proven track record in cGMP environment.
• Fast learner, adaptable, and excellent cross-collaboration and interpersonal skills.
• The desire and ability to work in a fast-paced, hands-on, start-up environment.
• IATA/ DOT Certification.

PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns

SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE: Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.

PREFERRED EDUCATION & EXPERIENCE:

• High School diploma + 2-4 years of experience in supply chain or warehouse operations
• IATA/DOT Certification
• Experience in a planning/scheduling and logistics role or equivalent
• Experience managing inventory in a GMP setting
• Experience working with specialized couriers
• Experience in a customer service role
• Experience in a fast-paced environment with flexible working hours

KNOWLEDGE, SKILLS AND ABILITIES:

• Proven track record in cGMP environment.
• Fast learner, adaptable, and excellent cross-collaboration and interpersonal skills.
• The desire and ability to work in a fast-paced, hands-on, start-up environment.
• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management), inventory management systems (e.g. ERP), and building / equipment management systems

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. During higher times of processing these activities may increase up to 4 hours at a time (except for breaks).

Generally, these activities may last for 1-2 hours at a time. While performing their duties, the employee must be able to do the following:

• Repetitive use of arms, wrists, and hands; use of fine motor skills and manipulations.
• Frequently stand, walk, sit, bend, stretch, and reach with hands and arms. Some overhead reaching and stretching will be required.
• Lift, push, or pull up to 25 lbs; carry receipts, shipments, inventory, and equipment.
• Standard lifting, pushing, and pulling would range from ground level to shoulder height.
• Confirm visual information in the environment such as electronic and paper steps were completed properly, information on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials.

SHIFT WORK, WEEKEND WORK, AND HOLIDAY COVERAGE

• Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required.  Days: Monday – Friday
• We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients. products to our patients. 

 

 

 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

 

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.