Materials Management Specialist - Innovative Gene Therapy Start Up

Menlo Park, California, United States · Manufacturing

Description

Location: Menlo Park, California

Reporting to: Director, Facilities

This an exciting opportunity for a suitable candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for an individual to be responsible for the physical and administrative tasks involved in the shipping, receiving, storing and distributing of materials, and supplies at their Menlo Park laboratory facility.

Duties and Responsibilities:

  1. Ensure adequate materials are available for campaigns including forecasting, procuring, receiving, inspection and releasing of materials in a timely manner.
  2. Receive GXP materials and adjust inventories, interface with other departments to ensure that GXP warehouse functions are being performed in a timely and accurate manner.
  3. Perform material receipt, inspection, quarantine, and release in accordance with approved procedures. Perform material rejection and disposal/destruction as appropriate. Generate deviation reports, CAPA’s and chance controls as required.
  4. Initiate and update materials management documentation, such as SOP’s, Work Instructions (WI’s) and other GXP documentation. Document/record and review GXP data and information. Review GXP documentation for accuracy, quality and compliance.
  5. Receive, inventory and storage of final product from manufacturing to temperature controlled storage.
  6. Perform packaging and shipping duties for final product, materials and equipment utilizing approved shipping methods and approved shippers.
  7. Perform periodic cycle counts, investigate discrepancies and implement corrective measures. Perform and/or participate in validation projects as needed.
  8. Always handle materials safely and follow CGMP’s, SDS’s, safety requirements and departmental policies and procedures.
  9. Perform receiving, handling, storage and inventory of compressed gas cylinders, dewars, dry ice and assistance with bulk operations.
  10. Perform hazardous and medical waste handling, inventory and shipment following industry guidelines and regulations.
  11. Remain knowledgeable and comply with all HAZMAT, workplace safety, OSHA, CFR, IATA, ICAO and IMDG regulations.
  12. Maintain a clean, organized and compliant warehouse and sampling work space.
  13. Provide general support to facility operations as needed.

14. Other activities as may be assigned.

Requirements

Job Requirements:

The ideal candidate for this position must have

Education & skills:

Benefits

Platinum Healthcare Coverage, Dental and Vision, 401 (k) Safe Harbor Plan, Life Insurance and more including competitive Salary, Bonus and Equity scheme (role dependent).

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