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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Director, Pipeline Programs S&T

Lake County, Illinois Req ID 2206920 Category Regulatory Affairs Division AbbVie

The Director, Pipeline Programs S&T (Science & Technology) develops and implements effective CMC strategies for worldwide pharmaceutical, analytical and drug-device combination product development activities required for regulatory agency submissions and post market product support for a designated therapeutic area.  The incumbent in this role will drive Operations CMC development for the Neuroscience therapeutic area in partnership ALB and ADT project teams. Works cross-functionally, to assure and focus availability of internal and external capabilities for projects assuring effective decision making in a timely and expeditious manner.   The Director, Pipeline Programs S&T (Science & Technology) develops and implements effective CMC strategies for worldwide pharmaceutical, analytical and drug-device combination product development activities required for regulatory agency submissions and post market product support for a designated therapeutic area.  The incumbent in this role will drive Operations CMC development for the Neuroscience therapeutic area in partnership ALB and ADT project teams. Works cross-functionally, to assure and focus availability of internal and external capabilities for projects assuring effective decision making in a timely and expeditious manner.   

Responsibilities:

  • Ensure CMC strategies are not only focused on delivering an NDA/BLA but also widely consider a robust product with consistent manufacturability and effective launch.  Provides input and supports Operations’ LRP decisions for the designated therapeutic area.
  • Represent the Operations function on pipeline project teams to ensure that R&D CMC strategies consider Operations CMC elements while ensuring overall alignment and consistent communication of ALB/ADT information to Operations teams.
  • Develop plans for RSL, SQL and validation runs at commercial sites or commercial manufacturing partners.
  • Accountable for driving the selection and qualification of key suppliers in collaboration with Operations functional project team leads.
  • Accountable for engaging with functional team leads and operations management to ensure early commercial site selection and the development of assurance of supply strategies for the asset. Also responsible for the timely communication of these plans to the development team
  • Effective communication of all aspects of operational requirements to the CMC program.
  • Work closely with regulatory to develop strategies or options to support the operations direction for the asset/product.
  • Ensure R&D manufacturing partners and technology selections are consistent with operations.
  • Assures prioritization and resource usage across the Science & Technology and broader Operations function is in line with overall pipeline prioritization. Determine the appropriate level of CMC data versus risk in accelerated programs.
  • Ensure launch plan requirements are communicated effectively through R&D CMC, Clinical and Commercial teams. Effectively communicate program/product milestones to Operations senior management ahead of governance meetings.
  • Ensure CMC strategies are not only focused on delivering an NDA/BLA but also widely consider a robust product with consistent manufacturability and effective launch.  Provides input and supports Operations’ LRP decisions for the designated therapeutic area.
  • Represent the Operations function on pipeline project teams to ensure that R&D CMC strategies consider Operations CMC elements while ensuring overall alignment and consistent communication of ALB/ADT information to Operations teams.
  • Develop plans for RSL, SQL and validation runs at commercial sites or commercial manufacturing partners.
  • Accountable for driving the selection and qualification of key suppliers in collaboration with Operations functional project team leads.
  • Accountable for engaging with functional team leads and operations management to ensure early commercial site selection and the development of assurance of supply strategies for the asset. Also responsible for the timely communication of these plans to the development team.
  • Effective communication of all aspects of operational requirements to the CMC program.
  • Work closely with regulatory to develop strategies or options to support the operations direction for the asset/product.
  • Ensure R&D manufacturing partners and technology selections are consistent with operations.
  • Assures prioritization and resource usage across the Science & Technology and broader Operations function is in line with overall pipeline prioritization. Determine the appropriate level of CMC data versus risk in accelerated programs.
  • Ensure launch plan requirements are communicated effectively through R&D CMC, Clinical and Commercial teams. Effectively communicate program/product milestones to Operations senior management ahead of governance meetings.
  • Ensure CMC strategies are not only focused on delivering an NDA/BLA but also widely consider a robust product with consistent manufacturability and effective launch.  Provides input and supports Operations’ LRP decisions for the designated therapeutic area.
  • Represent the Operations function on pipeline project teams to ensure that R&D CMC strategies consider Operations CMC elements while ensuring overall alignment and consistent communication of ALB/ADT information to Operations teams.
  • Develop plans for RSL, SQL and validation runs at commercial sites or commercial manufacturing partners.
  • Accountable for driving the selection and qualification of key suppliers in collaboration with Operations functional project team leads.
  • Accountable for engaging with functional team leads and operations management to ensure early commercial site selection and the development of assurance of supply strategies for the asset. Also responsible for the timely communication of these plans to the development team.
  • Effective communication of all aspects of operational requirements to the CMC program.
  • Work closely with regulatory to develop strategies or options to support the operations direction for the asset/product.
  • Ensure R&D manufacturing partners and technology selections are consistent with operations.
  • Assures prioritization and resource usage across the Science & Technology and broader Operations function is in line with overall pipeline prioritization. Determine the appropriate level of CMC data versus risk in accelerated programs.
  • Ensure launch plan requirements are communicated effectively through R&D CMC, Clinical and Commercial teams. Effectively communicate program/product milestones to Operations senior management ahead of governance meetings.
Qualifications:
  • PhD or advanced degree in related science field and additional business education or business degree with extended education/experience in drug development.
  • Minimum of 12 years’ experience in the pharmaceutical industry and 5+ years in a new product development environment. This experience should include successfully transitional projects from research to the market place.
  • Knowledge of therapeutic area preferred but not required.
  • Experience in a manufacturing/operations environment is preferred.  
  • At least 2 years of experience in an Operations CMC related role.
  • At least 3 years of experience supporting Neuroscience pipeline programs or marketed products.
Significant Work Activities: N/A
Travel: Yes, 25 % of the Time
Job Type: Experienced
Schedule: Full-time
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