Senior Manager – Drug Substance Technology & Engineering

Senior Manager – Drug Substance Technology & Engineering

We are seeking a Senior Manager to join our Drug Substance Technology & Engineering (DSTE) team at our Thousand Oaks, California site. In this onsite leadership role, you will oversee downstream purification manufacturing support unit operations supporting both clinical and commercial biologics drug substance. You will lead a team of downstream process engineers and play a key role in early phase technology transfer and the manufacturing execution, process optimization, and strategic improvement initiatives across all phases of development and the commercialization lifecycle.

Location:

Thousand Oaks, CA
Travel:
Up to 10% domestic and international travel

• Support the development, scale-up, tech transfer and manufacturing execution of cGMP clinical and commercial downstream purification processes including, but not limited to harvest, clarification, chromatography (Protein A, AEX, CEX, etc), viral filtration, UF/DF, and sterile filtration.
• Apply engineering principles and statistical analysis in order to:
  • Identify, develop and implement downstream process improvements into the manufacturing facility.
  • Resolve technical issues observed during scale-up and/or manufacturing execution of purification processes.
• Manage escalation and on the floor support as required to achieve successful scale-up and manufacturing objectives.
• Interface with process development teams to ensure processes are robust and are designed to deliver all quality attributes and enable manufacturing success.
• Collaborate with Process Development, Quality, Manufacturing, Regulatory, Validation and Supply Chain to drive continuous improvements into our business processes.
• Lead site activities for continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management.
• Ensure safety and compliance of process development activities.
• Collaborate with other site-functions and network drug substance teams in delivering plant goals.
• Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
• Ensure manufacturing operations are aligned with the registered process.
• Provide support for regulatory filing, inspection, and other CMC activities.
• Serve as member of the ATO DSTE leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities.

• Create multi-year technical strategies for advancing business performance.
• Ensures that safe practices are followed.
• Provides mentoring and expertise to staff on the downstream team.
• Motivates, develops, and coaches staff while promoting team collaboration.
• Applies effective management practices in the direction and development of others.

• Identifies and negotiates resources and develops timelines for project activities.
• Collaborates within the department and interdepartmentally.
• Provides scientific and technical leadership.
• Ensure department staff are adequately developed and trained.
• Provides adequate feedback through coaching and effective performance appraisal and development planning.
• Initiates and encourages scientific collaboration with groups outside the department.
• Manage project resources (material, labor, time, etc.), and elevate relevant issues to project lead and line-management.
• Build and maintain effective collaborations with partner organizations.

• Anticipates, proactively detects, and addresses problems related to departmental and interdepartmental activities.
• Inform and consults department head and senior staff appropriately.

• 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 OR
• Associate’s degree and 10 years of biologics process development or commercial-scale technical support experience OR
• High…