Executive Director, Engineering (FLEx Co-Lead)

The current opening is for FLEx Sterile 2, focused on the new Optima sterile filling installation scheduled to be Ready-For-Science in early 2030. The FLEx 2 Sterile suites contain a highly integrated, state-of-the-art sterile formulation and filling suite with sterile support equipment systems (e.g., DHO, Autoclave), capable of processing highly potent and higher-level biosafety pharmaceuticals and vaccines, supporting pre-clinical through late-phase manufacture. The equipment is highly dependent on robotic operations and novel containment systems for worker safety and sterility assurance.

General Responsibilities

• Set a strategic vision for FLEx aligned to PSDD and research division strategies and the long-range operating plan.
• Oversee operations in the set of FLEx assets through a tier process jointly managed with partner groups in manufacturing, research lab, GSE and GWES.
• Establish an end-to-end mindset and value stream for delivering clinical supplies agilely to ensure speed to clinic and best filing process.
• Create an entrepreneurial culture in FLEx valuing diversity, innovation, experimentation, belonging and potential.
• Collaborate with peer leaders across research, manufacturing and corporate divisions from Discovery to commercial manufacturing.
• Establish and manage financial budgets and forecasts for FLEx assets, including expense and capital expenditure.
• Define and demonstrate operational excellence in a clinical manufacturing setting, including capital project delivery.
• Create ERP/MES/Data systems enabling scientists to access data via intuitive interfaces to facilitate process development and streamline clinical supply.
• Maintain FLEx facility and equipment systems in a state of permanent inspection readiness.
• Recruit and develop staff through partnerships with external and academic partners, objective setting, stretch assignments and rewards and recognition.
• Serve as member of site and global leadership committees (e.g., safety, quality).

Required Qualifications

• BS or MS degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field with 10 years of relevant experience, OR PhD in a related field with 8 years of relevant experience.
• Deep subject matter expertise in pharmaceutical development and manufacturing across modalities, formulation approaches and product types.
• Minimum 2 years of management responsibility and experience developing staff.
• Fluency in the clinical quality management system and CMC process across modalities, including facility/technology development and qualification.
• Effective communication and collaboration skills with a diverse group of stakeholders.
• Demonstrated project management skills.

Critical Behavioral and Leadership Competencies

• Strong ability to lead engineering, technical and operational teams, drive organizational change and influence at all levels.
• Talent development: timely feedback and coaching, building the best team, managing performance, commitment to diversity, inclusion and belonging.
• Execution excellence: driving operational excellence by translating priorities into actionable steps.
• Business savviness: deep understanding of research division business areas and connectivity between clinical development, CMC and human health.
• Collaboration and change catalyst: cross-functional collaboration, stakeholder management and communication.
• Data-driven decisions and risk management: strong analytical, decision-making and problem-solving skills.
• Entrepreneurial mindset focused on delivering customer value.
• Resilience in a diverse and evolving environment.
• Emotional maturity for a shared leadership role.
• Ability to inspire and motivate others in a team environment.

Preferred Qualifications

• Relevant experience managing an operating pharmaceutical plant, in research or commercial manufacturing, especially beyond a 5-day, 8-hr shift schedule.
• Experience in pharmaceutical capital project management including design, construction, delivery and validation.
• Pharmaceutical and vaccine product development and commercialization experience, including filing and launch.