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Director Biologics API

Reference Number: 2917
Location: NJ or CA

Our client is a global specialty pharmaceutical company.  They have asked us to assist them in their search for a Director Biologics API.

This individual will be initially responsible for biologics commercial technology transfer strategy and delivery for new API processes from R&D into commercial manufacturing.  The incumbent provides critical leadership that aligns R&D biologics process development, scale-up and transfer to manufacturing, infrastructure planning (capital investment) , third party supply chain management, QA and business intelligence/market forecasting.  This includes actively managing relationships with suppliers and advising/signing off on technical, commercial and quality agreements and plans and protocols (e.g. tech transfer, process validation).

Major tasks and responsibilities will include:

  • Performs diligence, plans and constructs new build facilities or performs modifications/expansion of existing network assets to meet the biologics supply chain plan.
  • Active member of later stage biologic Product Development Teams to ensure that the processes that are developed and licensed as part of R&D activities are fit for commercial supply.
  • Responsible for supporting technical issues and projects for already commercialized API processes.
  • Biologics technology transfer and commercialization strategy and delivery for new biologic API processes originating from internal and external R&D organizations.
  • Leads technology transfer team for biologics processes from internal or external RD partners to internal or external commercial mfg. operations.
  • Provides/organizes technical support for commercialized biologics products.
  • Leads technology transfer team for biologics API processes from internal/external commercial manufacturing operations to alternate internal/external commercial manufacturing operations.
  • Assesses and supports implementation of new technologies for commercial biologic API processes.

We seek candidates with the following qualifications:

  • 5-10 years of development and manufacturing experience with biologics/biotech process development, and commercialization support.
  • BS/PhD in Biotechnology, Material Science or Engineering.
  • High technical expertise of biologic API processes/products that is aligned with commercialization strategy to meet business needs of the company.
  • Superior leadership and collaboration skills with R&D, commercial supply chain, engineering and quality assurance.
  • Strong analytical and problem-solving skills.
  • Strong communication skills.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2917. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.