Location: London, UK
Reporting to: Director, Global Supply Chain
Job summary
This role, within the Global Supply Chain (GSC) 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 role holder will ensure efficient supply scheduling and participate in manufacturing readiness for clinical and commercial Drug Product manufacturing. This will be done in close collaboration with Orchard Internal functions (MSAT, Supply Chain Logistics, GMP QA, CMC, Regulatory Ops, Clin Ops, Med Affairs, Commercial Ops) and Orchard CDMO partner(s).
Key Elements and Responsibilities
Planning and Scheduling
· Ownership of the clinical and commercial demand planning process which includes 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 manufacturing schedules are issued on time and aligned with the CDMO and internally, meeting expected service level and contractual requirements.
· 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.
· Support activities required to run the Executive S&OP meeting as part of the S&OP process.
· 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.
Manufacturing Readiness and Execution
· 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 meeting 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, in as far as possible, highlight any perceived risks or issues before they arise for timely cross-functional mitigation.
· Efficiently and effectively manage any last-minute manufacturing changes, issues, or cancellations.
· Ensure the GMP DP batch CDMO Release and Orchard Disposition systems are aligned thereby ensuring the use of these batches within the required timelines.
· 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.
· Other activities as assigned.
Requirements
Required capabilities and experience:
· At least 4+ years of demand planning and supply experience gained in regional or global supply chains in the pharmaceutical/biotech industry.
· Experience in scheduling DS/DP/API or other biopharmaceutical products with internal or external manufacturing setups.
· Direct exposure and experience in GMP Manufacturing desired but not essential.
· Exposure and/or good working knowledge of S&OP as a process.
· Fully operationally aware with a drive for results in challenging situations.
· Skilled in writing and reviewing SOPs, CAPA’s and work instructions
· Ability to operate in a fast-paced, highly regulated, multi-disciplinary environment.
· Strong commitment to accuracy and attention to detail
· Good understanding of Good Manufacturing Practices (GMP) and regulatory requirements.
· Ability to work independently as well as part of a team with good verbal and written communication skills.
· Must be able to: multi-task, be flexible, work in a close-knit team-oriented atmosphere
· Language: Fluency in English is essential; any other language is an asset.
Education
