Supply Chain Manager
1 month ago
This role is pivotal in ensuring best-in-class external manufacturing planning and scheduling with timely supply of Drug Product (DP) to our Qualified Treatment Centre (QTC) network. The successful candidate will ensure efficient supply scheduling and participate in manufacturing readiness for clinical and commercial Drug Product manufacturing.
Key Responsibilities
Ownership of the clinical and commercial demand planning process, including patient forecasting, demand shaping, and a staged approach, cross-functional rough cut scheduling process.
Ensure efficient manufacturing planning and scheduling of Drug Product (DP).
Create and issue short-term manufacturing schedules and long-term forecasts.
Ensure timely supply of DP towards our Distribution and Logistics function for Clinical and Commercial Operations to the QTC network to meet planned patient treatment timelines.
Participate in country-level POD meetings as the patient supply planning subject matter expert, partnering with commercial, medical affairs, regulatory, and market access.
Work closely with Quality Assurance (QA) to ensure timely disposition of manufactured GMP batches as per the defined supply timelines.
Ensure the Regulatory pathways necessary for Orchard to disposition all GMP DP batches are defined, agreed, and communicated to all relevant parties in advance of batch manufacture.
Act as the key responsible person between Orchard's Supply Chain and the CDMO's supply chain and manufacturing teams, ensuring alignment between both parties within the weeks and days leading up to DP batch manufacture.
Chair and participate in weekly manufacturing readiness internal meetings and regular supply planning and scheduling meetings with the CDMO.
Work with the CDMO and internally with MSAT to track the ongoing manufacture and CDMO release of all GMP batches and highlight any perceived risks or issues before they arise for timely cross-functional mitigation.
Play an active role in working with the CDMO to apply any future regulatory changes to current manufacturing and processes that have an impact on supply.
Manage and administer all CDMO manufacturing financial transactions, including POs and invoices associated with the manufacture of DP, including resolving monthly finance reconciliation queries.
Work with the manufacturing Science and Technology (MSAT) and Quality Assurance (QA) teams to ensure all 'in process' issues associated with the manufacture of any GMP DP batch are dealt with in an efficient, effective, compliant, and timely manner.
Requirements
At least 4+ years of demand planning and supply experience gained in regional or global supply chains in the pharmaceutical/biotech industry.
Skilled in writing and reviewing SOPs, CAPAs, and work instructions.
Good understanding of Good Manufacturing Practices (GMP) and regulatory requirements.
Must be able to multi-task, be flexible, and work in a close-knit team-oriented atmosphere.
Fluency in English is essential; any other language is an asset.
Minimum of bachelor's degree in fields such as Life Sciences, Business Management, Manufacturing, Engineering, Chemical, Bioprocessing, with relevant experience in Supply Chain Operations.
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