Job Description

  1. Lead projects focused on biologics technology transfer, process validation, and new technology evaluation/implementation.
  2. Lead site activities for process optimization, complex investigation, and product life cycle management.
  3. Lead teams with direct reports in Process Development group, manage key projects or business processes across functions.
  4. Collaborate with cross-functional teams and network drug substance teams to resolve complex challenges by applying advanced technical principles and concepts for troubleshooting.
  5. Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.
  6. Ensure safety and compliance of process development and/ or manufacturing activities.
  7. Provide support for regulatory filings, audits and inspections, and other CMC activities.
  8. Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities.

Job Requirements

  1. Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience
    1. Doctorate degree or a Master’s degree is highly preferred
  2. 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) and 2+ years of management experience.
  3. Strong and in-depth expertise in cell culture and/or purification processes.
  4. Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation.
  5. Strong communication skills, interact effectively with diverse internal and external stakeholders.
  6. Knowledgeable in regulatory filings and inspections.
  7. Familiarity in operational aspects of commercial biopharma manufacturing.
  8. Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing.