Drug Substance Technology Project Leader

Roche • Oceanside, CA

1d • Onsite

About The Position

As an integral part of Pharma Technical Operations (PT), PT Global MSAT, Engineering and Sustainability (PTT) plays a key role in leading a seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization and scalable manufacturing processes and technologies in support of the manufacturing network. Product and process robustness, efficiency and reliability are key performance indicators, PTT owns and drives continuous improvement. The Drug Substance Technology Project Leader will lead the development of the strategic technological roadmap for Drug Substance, focusing on technical innovation and alignment with PT long-term business objectives. This role involves interfacing with Pharma Technical Development, global MSAT, Engineering, and Site Manufacturing teams to ensure technical innovations align with global product and technology strategy. The leader will define the technology lifecycle with the asset lifecycle management team, identify critical milestones for re-evaluating standards, and represent the technological needs of the Drug Substance network in senior stakeholder interactions and key technical governance forums. The position also involves identifying and assessing technological innovations, translating them into actionable projects that improve product robustness and sustainability, overseeing a complex portfolio of strategic projects for efficiency gains and supply chain resilience, and leading the concept and pilot of new Drug Substance manufacturing technology selections towards defining technology standards. Additionally, the role includes authoring and approving technical documents and monitoring adherence to technological standards while mentoring team members.

Requirements

• BS/MS/PhD in Chemical/Biochemical Engineering or Life Sciences.
• 15+ years of relevant industrial experience in process development, industrialization, or manufacturing operations within the biotechnology/pharmaceutical industry.
• Extensive experience in matrix leadership and leading senior-level cross-functional teams to deliver aligned network solutions.
• Company-wide acknowledged expertise in Drug Substance manufacturing technologies and standardization.
• In-depth knowledge of pharmaceutical quality systems and ICH guidelines pertinent to biologics process development.

Responsibilities

• Lead the development of the strategic technological roadmap for Drug Substance, focusing on technical innovation and alignment with PT long-term business objectives.
• Interface with Pharma Technical Development, global MSAT, Engineering, and Site Manufacturing teams to ensure technical innovations align with global product and technology strategy.
• Define the technology lifecycle together with the asset lifecycle management team and identify critical milestones for re-evaluating standards.
• Represent the technological needs of the Drug Substance network in senior stakeholder interactions and key technical governance forums.
• Identify and assess technological innovations, translating them into actionable projects that improve product robustness and sustainability.
• Oversee a complex portfolio of strategic projects aimed at delivering systematic efficiency gains and achieving supply chain resilience.
• Lead the concept and pilot of significant new Drug Substance manufacturing technology selections towards the definition of technology standards.
• Author and approve technical documents, including user requirements, qualification strategies, and technology master plans.
• Monitor and ensure adherence to technological standards across the Drug Substance networks while mentoring technical team members.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees