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They will help coordinate starting material and drug product and finished packaged goods supply needs between CMOs and internal teams to ensure that all product supply needs are defined and met.
The candidate will be required to work closely with a cross-functional team and coordinate activities between Supply Chain, Quality, MSAT and the CMO.
The GEO Supply Chain Operations Associate will work with the Process Team Owner, GEO.
KEY RESPONSIBILITIES Manage ERP aspects for production efforts at CMO & Monitor and manage inventory levels of drug substance, drug product, finish goods and components as applicable at CMO site.
PO and Invoice Management generation, and coordination of POs Shipment Management Form completion, shipment coordination, inbound & outbound, DS/DP/bulk packs & samples Inventory Reconciliation manage monthly reconciliation process for relevant CMOs, prepare for and be primary SME/point of contact for inventory audits Coordination of reference standard supply with the relevant CMOs Coordination of annual stability samples with Novato and the relevant CMOs.
Accountable and responsible for maintaining accuracy of Tier 2 Master Data (planning and GMP production recipes, quality parameters, dispensing and sourcing rules, planning attributes, formulas, and routings) for Planning and GMP Production Recipes and Formulas (Not process instructions).
EXPERIENCE Minimum requirement of 3-5 years in Operations, Supply Chain or Quality.
BS/BA degree; life sciences, business, or supply chain management Required skills needed to accomplish the responsibilities/essential functions include: Will have a good understanding of the processes/unit operations assigned to the team.
Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
Strong written and verbal communication, commercial acumen.
A high level of initiative and questioning skills are key role requirements, as well as strong organizational skills.
Experience in supply planning or inventory management.
Experience in inventory reconciliation. xyswxtq
Working knowledge of GXP regulations.
Desired Skills: Desired skills to accomplish the responsibilities/essential functions include: Clinical Packaging Operations/Supply Chain Cold chain logistics knowledge
TPBN1_IJ
Sprachkenntnisse
- English
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