- Expiry Date: 03 February 2022
This role is accountable to manage supply chain functional duties for the Devens Cell Therapy manufacturing facility (CAR-T Therapies).
This role will manage patient supply and material planning, materials management, inventory control, product tracking (chain of identity and chain of custody), import/export permits, shipping/receiving, and cold chain logistics of personalized cell therapies produced at the clinical manufacturing site. Responsible for interpreting and analyzing demand and usage requirements of various operating supplies, general and critical raw materials, components, equipment, and maintenance supplies.
Knowledge, Skills, and Abilities:
Education: Bachelor’s degree required in Life Sciences, Supply Chain, or similar
Preferred but not required:
Certification in CPIM, CSCP, and/or CLTD
7+ years relevant work experience required
3+ years of experience supporting ERP systems (preferably SAP).
An equivalent combination of education, experience and training may substitute.
People management experience
Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization
Experience with lean six sigma projects and change execution management
Experience in a Site Supply Chain Organization
Advanced proficiency in Site Scheduling / planning / ERP systems and analytics tools
Advanced knowledge of fundamental concepts of materials management, planning, and site production scheduling
Ability to effectively communicate problem statements and viable solution options using pro vs. con and cost vs. benefit approaches
Ability to present data and analyses in an organized, clear and concise manner
Advanced proficiency in MS Office applications
Proficient written and verbal communication skills
Ability to work independently for extended periods of time
Ability to work as a team and mentor peers
Ability to understand and solve complicated supply and demand problems
Intermediate knowledge of cGMP/Pharmaceutical regulations
Duties and responsibilities:
Maintain and understand full plant scheduling process.
Understand impacts of demand on planning cycle looking forward.
Monitor product life cycles and alert appropriate team members to any actionable inventory requirements and disruption to supply.
Drive Materials Release process and be aware of any and all shortages.
Conduct investigation and root cause analyses on any supply disruptions or material quality issues and report on corrective actions.
Manage Site Supply Chain Standard Operating procedures
Own and manage deviations and corrective/preventive actions
Own and manage change controls
Optimize internal capacity and capabilities to ensure clinical needs can be met.
Serve as single point of contact between Global Patient Operations, Global Supply Chain and site
Establish a well-designed integrated demand and supply plan from raw materials to final distribution
Manage cell material handling and storage for leukapheresis, intermediate and drug product
Track and report metrics to track and manage completion of objectives and projects
Ensure appropriate training and qualification for staff activities performed
Foster a culture of compliance and strong environmental, health, and safety performance
Promote a mindset of continuous improvement, problem solving, and prevention
Participate in cross-functional teams to improve systems, processes or internal/external performance.
Performs other tasks as assigned
About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.