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02.08.22
Bothell, Washington, United States
Manager, ERP Supply Chain
Manufacturing
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.

POSITION SUMMARY:

The incumbent is responsible for the Oracle Enterprise Resource Planning (ERP) Supply Chain Management (SCM) modules that support the technical operations function.  This role will manage modules including quality, manufacturing, product data hub, inventory and security and control which support our GMP operations. The incumbent provides guidance and support through their strong understanding of ERP, regulatory requirements, including both GxP and SoX, as well as a comprehensive knowledge of Oracle Fusion.

KEY ROLE AND RESPONSIBILITIES:

SCM system life cycle documents including user requirements, functional technical specifications, and configuration specifications

  • Lead technical operations to deliver user requirements for supply chain, quality, manufacturing, inventory warehousing and product data hub
  • Facilitate use case for new system / software or enhancements related to ERP and ERP/MES.  Drive workshops to ensure SCM functionality meets requirements
  • Responsible for executing validation testing including installation, operational and performance qualifications (IQ/OQ/PQ).
  • Deliver and maintain overall Oracle SCM validation package
  • Develop, revise and review SOPs, qualification/validation protocols/package with ongoing awareness of changes in business and compliance requirements.
  • Collaborate with IT to oversee system upgrades and system administration activities

Process libraries and ensure the libraries are up to date and accurate

  • Map user requirements to the specific lyell processes
  • Maintain process document and work instructions

Oracle SCM change management

  • Oracle SCM owner for quality records including change controls, deviations and CAPAs.  Point person to perform system change impact assessment
  • Coordinate successful rollout of ERP/MES changes including communications, training, support and documentation.
  • Partner with Technical Operations, Finance, and IT to implement and support a unified Oracle system change request and release management process in compliance with GMP and SOX requirements

Training and support to supply chain, quality, warehouse, and manufacturing

  • Develop and maintain training materials and provide system and process training
  • Document incidents and problems and corresponding solutions
  • Host weekly support meetings to track open, closed and pending tickets
  • Manage Lyell’s ERP Support Program for technical operations.  This includes business continuity, off hours and on call support.

Oracle SCM to GMP system and process interfaces

  • SME on Oracle SCM and supply chain processes
  • Serve as liaison for all system interface projects with Oracle SCM
  • Represent supply chain for all system interfaces projects with Oracle SCM
  • Document/diagram E2E integrated process flows and business scenarios to ensure optimization and synchronization across all GMP systems and process
  • GMP systems include Oracle SCM, MES, LIMS, EM, CMMS, scheduling and cell orchestration platforms.

Additional Responsibilities

  • Owner for Oracle SCM reporting and dashboards.  Support queries and reports to address operating needs
  • Executes Oracle SCM periodic review (user access (through MasterControl), audit trail, quality records)
  • Continuous improvement to simplify work processes, decrease turnaround times

PREFERRED EDUCATION:

  • BA/BSc in Statistics, Mathematics, Computer Science, Engineering or other close-related fields with a minimum of 7 years’ experience; or
  • MBA or MSc in Statistics, Mathematics, Computer Science, Engineering or other close-related fields with a minimum of 4 years’ experience

 PREFERRED EXPERIENCE:

  • Minimum 7 years of ERP system experience in biotechnology or pharmaceutical industry, with vendor oversight experience
  • A minimum of 5 years management experience in supply chain or manufacturing operations
  • Demonstrated extensive experience with Oracle Fusion (SCM modules)
  • Proven experience with SOX and GxP, and 21CFR part 11 requirements
  • Experience with cell therapies
  • Experience with Oracle Fusion Software as a Service
  • Experience with middleware platforms such as Mulesoft or Dell Boomi

KNOWLEDGE, SKILLS AND ABILITIES:

  • Performed at least 1 (one) full life cycle implementation of Oracle EBS/Cloud Modules
  • Managing medium- to large-scale projects
  • Management of a full-service end-user technical support 

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.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
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.
 
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