Materials Management Specialist - P19-26
Menlo Park, California, United States
Orchard Therapeutics Limited is a global biotechnology company dedicated to bringing transformative gene therapies to children with severe and life-threatening orphan diseases. The company has been founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.
Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion-dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.
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, North America. (OTNA) is looking for an individual to be responsible for the physical and administrative tasks involved in the receiving, storing, shipping and distributing of materials, and supplies at their Menlo Park laboratory facility.
- Work closely with buyer/planner to ensure adequate materials and supplies are being purchased for campaigns, development, testing and on hand inventory
- Utilize proper forecasting, planning, procurement and purchasing to ensure materials and supplies are made available for use
- Participate/Lead monthly update meetings, perform regular cycle counts, adjust inventories, investigate discrepancies, implement corrective measures and ensure replacement materials are purchased to maintain proper supplies for use by Technical Operations, Analytical Operations, Supply Chain Management and other groups related to West Coast and EU Operations
- Interface with department customers to ensure that warehouse functions are being performed in a timely and accurate manner and all required and requested materials are available
- Perform receiving activities of controlled and general materials, equipment and supplies with material receipt, inspection, quarantine, temperature sensitive and ambient materials storage and release in accordance with approved practices and procedures
- Perform material rejection and disposal/destruction as appropriate for expired, unapproved and/or failed materials
- Check goods against purchase orders or invoices, adjust inventories and maintain records
- Perform delivery and releasing/stocking of materials in a timely manner
- Responsible for receipt, issuance, inventory and inventory tracking of stored AO and CTO samples
- Initiate and update materials management documentation, such as SOP’s, Work Instructions (WI’s), logs and other documentation as needed. Document/record and review GxP data, information and documentation for accuracy, quality and compliance
- Perform domestic and international shipping duties for final product, testing, other materials and equipment utilizing industry approved shipping methods, shipping, transfer or customs documents and use of approved shippers, while utilizing approved shipping vendors
- Generation and reporting of monthly department metrics & KPI’s
- Responsible for budget input and generation, budget management and tracking, budget reconciliation and accrual in conjunction with the buyer/planner budget planning and generation activities
- Maintain safe working areas and environments in all areas of responsibility. Handle all materials safely and follow all GxP, Safety Data Sheets and all other safety requirements and departmental policies and procedures
- Perform receiving, handling, storage, inventory and changeout of compressed gas cylinders, dewars and dry ice, utilizing safe practices, approved SOP’s or work instructions (WI’s), logs, and other tracking documentation as needed
- Perform backup hazardous and medical waste handling, inventory and shipment as needed following industry guidelines and regulations. Interface with Environmental Health & Safety and the hazardous waste disposal company as needed
- Maintain all current training & certifications utilizing Master Control and other available internal and external trainings, comply with all HAZMAT, DOT, workplace safety, OSHA, CFR, IATA, ICAO, IMDG, customs, transfer and transfer agent regulations
- Maintain a clean, organized and compliant warehouse and sampling work space
- Provide buyer/planner support and backup purchasing activities as needed
- Provide general support to facility operations as needed
- Other activities as may be assigned
The ideal candidate for this position must have:
- 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
- Experience working in a similar role in a biotech, pharmaceutical or medical device company, including the handling, packaging and shipping of sensitive cryopreserved materials
- Strong computer skills with an emphasis on the full Microsoft Office Suite of programs, with strong Excel skills preferred, NetSuite ERP system, electronic file storage, online interface and scheduling with 3rd party vendor systems and other as needed
- Prior experience performing similar duties in a GXP environment and a basic understanding of materials management, inventory control and material/invoice reconciliation. General knowledge of other operational areas such as QA, CTO, AO, Planning is desired
- Ability to develop solutions to a variety of problems of moderate scope and complexity while referring 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, support network and third-party vendors
- Must be a self-starter, with the ability to perform described work with minimal supervision
- Must be organized, customer focused, and have the ability to multitask
- Excellent verbal and written skills required
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plan. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k).
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.