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Senior Director, Drug Product Technology

Reference Number: 2765
Location: MA

Our client is a rapidly growing, specialty biopharmaceutical company.  They have retained us to assist them in their search for a Senior Director, Drug Product Technology.

The Senior Director, Drug Product Technology is responsible for robust process development, scale-up and management of technology transfer to contract manufacturing organizations for both sterile and oral pharmaceutical drug products.  The incumbent will identify and manage process improvement activities and provide technical support for existing commercial manufacturing operations.  He/she will lead and develop the drug product development team and collaborate effectively with internal and external resources.

Major tasks and responsibilities will include:

  • Leads, develops and implements Drug Product Development strategy to support the development and manufacturing of drug product at all stages of development.
  • Provides technical support to optimize and improve manufacturing process, transfer technology to CMO’s and assist in quality investigations for commercial manufacturing.
  • Responsible for delivering clinical supplies at all stages of development.
  • Develops and leads a high performing drug product technology team.
  • Responsible for technical input for CMC sections of regulatory filings.
  • Selects external partners for formulation development and manufacturing.
  • Oversees execution of drug product development projects.
  • Collaborates effectively with other departments including Quality, Regulatory, PPM and R&D.
  • Proactively manages risks.
  • Sets high standards for compliance to meet/exceed regulatory agencies requirements.

We seek candidates with the following qualifications:

  • BS in Pharmaceutical Sciences or equivalent (advanced degree preferred).
  • 12+ years of sterile and oral drug product development experience in the pharmaceutical industry.
  • 8+ years of experience being in a managerial role.
  • Comprehensive knowledge and experience with drug product development, scale up and manufacturing operations for both sterile and oral drug products.
  • Experience and knowledge to anticipate various technical and regulatory hurdles in developing products for global registration and commercialization.
  • In-depth understanding of the issues and controls for the scale-up of products, as well as a good understanding of the manufacturing equipment and operations for both pilot and commercial scale.
  • Strong scientific principles as well as established practices such as Quality by Design.
  • Extensive experience in overseeing Contact Manufacturing Organizations for both development and manufacturing operations.
  • Excellent interpersonal and leadership skills. Ability to influence and motivate others in achieving desired outcomes and decisions.
  • Effective use of communication skills, both oral and written.
  • Demonstrates ability to see beyond own function to understand business issues and implement best practices.
  • Exceptional problem solving skills, fosters excellence throughout the organization.
  • Ability to leverage an in-depth understanding of the organization to build up credibility and acceptance of projects.
  • Demonstrated ability to lead and develop teams and individuals.

 

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 2765. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.