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Business Process Manager-GMP Documentation (Contract)

Supply Chain Management | Remote, CA | Contract

Job Description


About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Job Description:

Allogene is looking for a Business Process Manager-GMP Documentation with experience authoring, editing and standardizing Supply Chain management Business Process / cGMP documents associated with CMO/subcontract/external manufacturing, warehouse, inventory management, materials handling, distribution & logistics, Master Data Management, and related processes).  The successful candidate must be comfortable proactively coordinating with internal and external subject matter experts to create, revise and maintain GMP documentation including SOPs, WIs, Job Aids, and other reference materials.  The Business Process Manager-GMP Documentation should have experience in SAP ERP (preferably S/4HANA). This is a 6-month contract with potential for extension.

 

Requirements

  • Bachelor’s Degree, preferably in the Supply Chain, Life Sciences or Engineering field
  • Experience in SAP ERP, preferably S/4HANA
  • Technical writing experience of standard operating procedures including supply chain, materials management, master data management, manufacturing procedures and instructions
  • 3-10 years industry experience in a cGMP environment preferred
  • Knowledgeable in FDA GMPs (21 CFR, 210, 211)
  • Excellent written and oral communication skills, ability to work in a fast-paced team-oriented environment 
  • Experience in a biotech/pharmaceutical supply chain, master data management, warehouse and/or manufacturing
  • Well organized and detail oriented
  • Ability to handle multiple projects or tasks simultaneously and coordinate activities with business subject matter experts



As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.