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Associate Director / Director, CMC Supply Chain

Full Time
74 E. Swedesford Rd, Suite 100, Malvern, PA, US
3 months ago | Requisiton ID:1021

The Associate Director / Director, CMC Supply Chain will be primarily responsible for establishing robust and effective supply chains for the launch and sustained commercialization of Venatorx’s products.  He/She will a) provide supply chain-logistic support of products still in development, b) ensure considerations of export / import requirements, tariffs and regulations are considered in establishment of development and commercial supply and launch plans, and c) demonstrate excellence in vendor interactions to optimize quality, compliance, timelines and overall cost in development and commercialization.

 

 Duties:

  • Define commercial supply chains from API production through commercial distribution channels. Define manufacturing launch plans for Venatorx’s future commercial products. Evaluate 3PLs, serialization vendors and distributors to define commercial supply chain.
  • Leverage understanding of 3PLs, serialization vendors, export / import requirements, packaging & labeling, barcodes, serialization, testing on import, tariffs and regulations both in establishment of commercial supply chains and to support supply chain transactions across development and commercialization.
  • Establish best practices for Supplier Relationship Management. Optimize commercial supply chains for quality, compliance, timelines and overall cost while minimizing risk for the final stages of development and commercialization.  
  • Align the commercial forecasts with unit forecasts and market activities, creating an accurate demand signal for supply planning team/ plants in collaboration with stakeholders such as Production, Marketing, Finance, Business Development, Regulatory and Quality Operations
  • Support contract negotiations and completion of commercial supply agreements and related contracts with requisite partners.
  • Partner to develop contract best practices to insure that all activities at external vendors are performed in compliance with Quality and EHS standards.
  • Insure that all needed studies are performed to support global shipping requirements and release of material in desired markets.
  • Actively participate and/or lead in stakeholders meetings to develop and implement strategy as well as ensure operational excellence is achieved.  
  • A Secondary role would be to contribute to the optimization of CMC development supply chains. 

 

Qualifications: 

  • Bachelor's degree with 10+ years of experience in the pharmaceutical/and or biotechnology industry in a supply chain planning/launch role.
  • PhD or Masters Degree with 5+ years of experience in the pharmaceutical/and or biotechnology industry in a supply chain planning/launch role.
  • Experience in product launch and commercial CMC aspects of drug development e.g. Establishment of Supply Chain, Validation, shipping studies, import/export requirements, tariffs, etc.
  • Broad knowledge of CMO/CDMO, 3PL and distribution landscape
  • Knowledge of operational excellence and continuous improvement principles as applied to supply chain and manufacturing operations principles
  • Strong negotiation skills, broad understanding of business/financial acumen, excellent written/verbal communication, and effective problem solving skills

 

                                                     Equal Employment Opportunity/M/F/disability/protected veteran status