QUALIFICATIONS

• Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience OR
• Master’s degree and 6 years of biologics process development or commercial-scale technical support experience OR
• Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience
• 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) and 2+ years of management experience.
• Strong and in-depth expertise in cell culture and/or purification processes.
• Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation.
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders.
• Knowledgeable in regulatory filings and inspections.
• Familiarity in operational aspects of commercial biopharma manufacturing.
• Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing.
  Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

The Senior Manager will apply process engineering subject matter expertise to support technology transfer and ongoing cGMP production of commercial protein biologics processes. Scope of work could include:

• Lead projects focused on biologics technology transfer, process validation, and new technology evaluation/implementation.
• Lead site activities for process optimization, complex investigation, and product life cycle management.
• Lead teams with direct reports in Process Development group, manage key projects or business processes across functions.
• Collaborate with cross-functional teams and network drug substance teams to resolve complex challenges by applying advanced technical principles and concepts for troubleshooting.
• Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.
• Ensure safety and compliance of process development and/ or manufacturing activities.
• Provide support for regulatory filings, audits and inspections, and other CMC activities.
• 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.