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Director, Downstream Purification

Reference Number: 2982
Location: MA

Our client is a biopharmaceutical company focused on developing innovative RNA-based therapeutics.  They have asked us to assist them in their search for a Director, Downstream Purification.

The Director, Downstream Purification is responsible for scientific and technical oversight of the company’s downstream manufacturing processes from full scale process validation through commercialization, as well as life cycle management within their internal and external network for drug substance.  This leader will work in close collaboration with Process Development, Manufacturing, CMC quality and CMC regulatory groups at various sites, as well as with a network of external manufacturers.  This position reports to the Sr. Director, Manufacturing, Sciences & Technology within the Global Technical Operations group.

Major tasks and responsibilities will include:

  • In close collaboration with the process development functions, responsible for delivering on large scale technical transfer activities for phase 3 commercial supply; establishing process control strategies and specification windows for manufacturing during commercialization at scale; and assuring that clinical batches are representative of process capabilities.
  • Oversees large scale manufacturing process troubleshooting to ensure continued delivery of high quality products.
  • Interfaces with internal departments and external contract manufacturing organizations (CMOs)/contract research organizations (CROs) to ensure process operations are compatible.
  • Addresses production issues in collaboration with quality and regulatory teams. Conducts investigations in support of manufacturing issues.
  • Conducts process validation at scale, from writing protocols through execution across the drug substance manufacturing network.
  • Manages CMC authoring activities for Drug Supply manufacturing.
  • Oversees data management and process monitoring activities (Statistical Process Control).
  • Oversees the manufacturing operations, ensuring their alignment with the registered processes.
  • Provides oversight and write development and process documents consistent with supporting regulatory filings.
  • Provides oversight and support for technical investigations and change controls.
  • Defines relevant operational/technical standards and practices for manufacturing sites.
  • Defines raw material and consumable specifications and standards for manufacturing sites.

We seek candidates with the following qualifications:

  • MS with 10 years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline; experience with managing teams in a cGMP environment preferred.
  • A proven track record of technical accomplishments with strong practical knowledge of the technologies related to large scale purification, automation, validation and process engineering.
  • Experience or in-depth knowledge of validation in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
  • Experience in the process development and technology transfer for commercial biotechnology manufacturing.
  • In-depth knowledge of regulatory requirements for filing drug applications in the US and Europe, including hands-on regulatory experience with the US and European agencies.
  • Superb technical writing skills and experience with documenting development and processes in support of regulatory filings.
  • Strong interface and collaboration skills across various groups internally and externally.
  • Effective communicator of ideas, project goals and results internally and externally.
  • Demonstrated success in developing staff, including effective performance feedback and coaching.
  • Strong organizational skills and the ability to successfully manage multiple technical projects and priorities at the same time.
  • Analytical and strategic thinking skills and experiences, with a strong ability to translate these and implement them operationally.
  • Knowledge of Lean Six Sigma tools.

 

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 2982. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.