Director, Technical Operations (Small Molecule Drug Substance)

Job Description

At our company, we aspire to be the premier research‑intensive biopharmaceutical company, using the power of leading‑edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose‑built, agile small‑molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast‑following into production with a focus on quality, safety, and operational excellence.

At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small‑molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

Bilingual Director and Technical Operations Leader

The Director and Technical Operations Leader must bring deep and exceptional expertise in small‑molecule drug substance technical operations, including strong understanding of manufacturing processes, equipment, process engineering, scale‑up, validation, and troubleshooting, as well as the facility systems and their intersections with specific product and process requirements. The individual should have broad experience across the product lifecycle, including tech transfer, continued process verification, and lifecycle management, enabling sound judgment and confident decision‑making in a highly regulated environment.

The ideal candidate will demonstrate strong leadership and cross‑functional collaboration across Science and Technology, Operations, Quality, Supply Chain, and Regulatory functions. They must have the technical operations depth and leadership capability to drive right‑first‑time execution, support deviation reduction, root cause analysis, CAPA effectiveness, and reliability improvements, while ensuring stable, compliant supply and strong site performance.

This role requires a leader who can combine technical operations mastery with the ability to build and lead teams, influence, develop people, and drive decisions that support technical and operational excellence, GMP compliance, regulatory readiness, data integrity, and audit readiness.

Technical Operations Subject Matter Expertise

• Deep expertise in small‑molecule drug substance manufacturing operations, including equipment, facility and infrastructure systems, site operations, process engineering, scale‑up, validation, and troubleshooting.
• Serves as the site Subject Matter Expert (SME) for equipment and facility‑related technical issues.
• Understands and manages the intersection of process, product, equipment, and facility design to ensure robust, reliable performance.
• Connects and harmonizes with the broader technical operations network to align approaches across similar equipment and processes.
• Supports the industrialization of new technologies and scientific advances.

Product Introduction, Technology Transfer Leadership and Execution Readiness

• Owns site‑level product introductions and technology transfer strategy and execution, including receiving unit responsibilities for tech transfers.
• Integrates operations with product science to ensure end‑to‑end risk assessment, control strategy alignment, and on‑time, right‑first‑time introductions.
• Ensures execution readiness through strong process stewardship and operational risk management.
• Evaluates scale‑up strategies, process performance robustness, and manufacturability to enable successful site implementation.

Technical Problem Solving and Compliance Leadership

• Demonstrates strong judgment and analytical capability to resolve technical challenges and sustain supply.
• Supports regulatory technical queries impacting the site.
• Operates with a strong GMP, data integrity, and audit readiness mindset.
• Ensures technical decisions support compliant, reliable, and high‑quality supply.
• Acts as an escalation point for complex, multi‑site technical issues.
• Ensures readiness for regulatory inspections and internal audits; provides rapid, authoritative technical responses with defensible evidence packages and upholds data integrity and traceability.

Technical Performance Monitoring, Risk Mitigation, and Continuous Improvement

• Proactively monitors commercial performance to detect trends and drive preventive actions.
• Leads technical risk reviews and implements timely mitigations to sustain and improve product and process performance.
• Interprets technical and operational data to inform prioritization and investment decisions by business leaders.
• Systematically feeds production insights back into development and network technology strategies.

People and Transformational Leadership for Technical Operations Excellence

• Builds a culture of safety, scientific rigor, accountability, continuous improvement, inclusive leadership, and team capability development.
• Ensures the site has the right technical competencies through effective workforce planning, succession planning, and capability‑building for critical skills and subject‑matter expertise.
• Sponsors business process improvement by defining how work is done, streamlining processes, and integrating digital and data‑enabled methods while maintaining compliance and data integrity.
• Drives mindset and leadership shifts across Technical Operations; partners with Operations and Quality to execute transformation programs and embed new ways of working.
• Sponsors digital and analytics capabilities, such as process data platforms, CPV analytics, and advanced modeling, to improve monitoring and decision‑making.
• Leads portfolio prioritization, resource allocation, and governance to support commercial sustainment.
• Possesses strong written and oral communication skills and the ability to drive results through team leadership.

Qualifications

• Bachelor’s Degree – preferably in Science or Engineering.
• 10+ years of experience in small‑molecule drug substance process or product development and/or manufacturing technical operations.
• 7+ years of experience, with an advanced degree in Chemistry, Chemical Engineering or related discipline.
• Proven track record in new product introduction, tech transfer, PPQ, commercial scale‑up, process validation, and lifecycle management.
• Knowledge of GMP, ICH guidelines, process safety, and Quality Systems; inspection readiness leadership.
• Strong experience leading complex investigations.
• Evidence of driving organizational transformation: capability building, operating model changes, and cross‑functional alignment.
• Exceptional stakeholder management, communication, and influence skills; ability to lead through ambiguity and across geographies.
• Prior responsibility for site portfolios.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

Location Eligibility

U.S. and Puerto Rico residents only. San Francisco residents only: we will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents only: we will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.