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In this vital role you will be a people leader and cross-functional integrator responsible for end-to-end process governance and execution support within Drug Product Supply operations at the Thousand Oaks campus. This role ensures the site maintains a strong operating system for manufacturing readiness, technical governance, issue resolution, and continuous improvement across multiple unit operations and enabling processes, with accountability for driving alignment across key site forums, priorities, and decision-making bodies.
Job Responsibility
Lead, coach, mentor, and develop the manufacturing process owners within the manufacturing organization
Foster a culture of collaboration, continuous improvement, accountability, and high performance across the team
Provide guidance, performance feedback, and support for career development plans for direct reports
Set clear priorities, define role clarity, and establish coverage plans so the PPO team can flex across site needs
Ensure strong collaboration and coordination between Manufacturing and key partners
Provide governance and execution support to ensure smooth, compliant, and reliable manufacturing operations
Manage and improve manufacturing processes to increase productivity, reduce waste, and maintain product quality and compliance
Strengthen process discipline, documentation quality, and operational readiness across site processes
Serve as an escalation point for complex execution topics
Ensure manufacturing activities are performed in compliance with cGMP and all applicable regulatory requirements
Support inspection and audit readiness by ensuring appropriate documentation, escalation pathways, and governance transparency
Support site teams that own compliance-critical programs
Ensure disciplined execution and timely closure of quality actions, CAPAs, and effectiveness verification activities
Support and reinforce a strong safety culture
Provide oversight and drive process improvement initiatives
Use lean manufacturing and other continuous improvement tools
Analyze operational and quality data to identify trends, solve complex problems, and implement corrective actions
Partner with site stakeholders to ensure readiness for new processes, new products, and major operational changes
Support risk identification, issue resolution, and execution readiness
Facilitate, or ensure strong facilitation of, key site governance forums
Support the site project governance operating model, including plant project prioritization
Act as a point of contact for process owners during troubleshooting and resolution of manufacturing-related issues
Stay current on technological advancements and assess opportunities for adoption
Support introduction and scale-up of new technologies, equipment, and systems
Partner cross-functionally to ensure technology-related changes are effectively planned, implemented, and sustained
Requirements
Doctorate degree and 2 years of Manufacturing and Operations experience
Master’s degree and 6 years of Manufacturing and Operations experience
Bachelor’s degree and 8 years of Manufacturing and Operations experience
Associate’s degree and 10 years of Manufacturing and Operations experience
High school diploma / GED and 12 years of Manufacturing and Operations experience
Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Bachelor’s degree in Life Sciences, Physical Sciences, Engineering, or a related technical discipline
8+ years of manufacturing, operations, technical operations, or process support experience in biotechnology, biopharmaceutical, pharmaceutical, or other highly regulated manufacturing environments
6+ years of leadership experience, including direct people leadership and/or leadership of cross-functional teams, programs, or site-level initiatives
2+ years of experience managing, coaching, or developing direct reports, technical teams, process owners, or matrixed contributors
Experience in Drug Product manufacturing operations, including aseptic processing, filling, inspection, packaging, validation execution, or manufacturing readiness
Strong working knowledge of cGMP operations and quality systems, including deviations, CAPAs, change control, effectiveness verification, audit/inspection readiness, SOPs, batch records, and controlled documentation
Demonstrated ability to lead governance forums, drive cross-functional alignment, prioritize competing site needs, and ensure disciplined follow-through on actions and commitments
Experience troubleshooting complex manufacturing, technical, quality, or operational issues in partnership with Quality, Engineering, Automation, Supply Chain, Maintenance, Facilities, and Technical Operations
Demonstrated ability to analyze operational and quality data, identify trends, drive root cause analysis, and implement sustainable corrective and preventive actions
Experience applying lean manufacturing, operational excellence, value stream mapping, capacity planning, waste reduction, or continuous improvement tools to improve manufacturing performance
Strong technical writing and communication skills, with the ability to translate complex technical and operational topics into clear decisions, actions, and governance updates
Experience supporting implementation or sustainment of manufacturing technologies, automation systems, digital tools, MES/electronic batch records, data visualization platforms, or process monitoring systems
Demonstrated ability to make sound decisions in complex, ambiguous, and highly regulated environments while balancing safety, quality, supply, compliance, and business priorities
Proven ability to build trust, manage conflict effectively, influence without authority, and positively advance the culture of an organization
Strong business acumen, including experience with goal setting, resource planning, budget awareness, inventory control, performance metrics, and manufacturing operating systems
Nice to have
Bachelor’s degree in Life Sciences, Physical Sciences, Engineering, or a related technical discipline
8+ years of manufacturing, operations, technical operations, or process support experience in biotechnology, biopharmaceutical, pharmaceutical, or other highly regulated manufacturing environments
6+ years of leadership experience, including direct people leadership and/or leadership of cross-functional teams, programs, or site-level initiatives
2+ years of experience managing, coaching, or developing direct reports, technical teams, process owners, or matrixed contributors
Experience in Drug Product manufacturing operations, including aseptic processing, filling, inspection, packaging, validation execution, or manufacturing readiness
Strong working knowledge of cGMP operations and quality systems
Demonstrated ability to lead governance forums, drive cross-functional alignment, prioritize competing site needs
Experience troubleshooting complex manufacturing, technical, quality, or operational issues
Demonstrated ability to analyze operational and quality data, identify trends, drive root cause analysis
Experience supporting implementation or sustainment of manufacturing technologies, automation systems, digital tools
Demonstrated ability to make sound decisions in complex, ambiguous, and highly regulated environments
Proven ability to build trust, manage conflict effectively
Strong business acumen
What we offer
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts