Materials Management Specialist - Innovative Gene Therapy Start Up
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:
- Ensure adequate materials are available for campaigns including forecasting, procuring, receiving, inspection and releasing of materials in a timely manner.
- 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.
- 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.
- 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.
- Receive, inventory and storage of final product from manufacturing to temperature controlled storage.
- Perform packaging and shipping duties for final product, materials and equipment utilizing approved shipping methods and approved shippers.
- Perform periodic cycle counts, investigate discrepancies and implement corrective measures. Perform and/or participate in validation projects as needed.
- Always handle materials safely and follow CGMP’s, SDS’s, safety requirements and departmental policies and procedures.
- Perform receiving, handling, storage and inventory of compressed gas cylinders, dewars, dry ice and assistance with bulk operations.
- Perform hazardous and medical waste handling, inventory and shipment following industry guidelines and regulations.
- Remain knowledgeable and comply with all HAZMAT, workplace safety, OSHA, CFR, IATA, ICAO and IMDG regulations.
- Maintain a clean, organized and compliant warehouse and sampling work space.
- Provide general support to facility operations as needed.
14. Other activities as may be assigned.
The ideal candidate for this position must have
- Experience working in a similar role in a biotechnology company, including the handling, packaging and shipping of sensitive cryopreserved materials
- Ability to develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
- Exercises judgement within defined procedures and practices to determine appropriate action.
- Develops and maintains productive relationships with internal customers and third-party vendors.
- Ability to pass required DOT hazardous waste shipping testing/certification.
- Be reliable, with a stable work history
Education & skills:
- BA/BS and a minimum of 2-4 years related industry experience or high school degree and a minimum of 5-7 years related industry experience or equivalent combination of education and experience.
- Strong computer skills in Microsoft Word and Excel required
- Must be organized, customer focused, and have the ability to multitask
- Excellent verbal and written skills required
- Prior experience performing similar duties in a GXP environment and a basic understanding of materials management, inventory control and GXPs. General knowledge of other operational areas such as QA, Materials Planning, etc, desired.
- Good communication and collaboration skills preferred
- An ability to be productive and successful in an intense work environment
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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