Director, Technical Operations; Molecule Drug Substance

Job Overview

We are a leading research-intensive biopharmaceutical company dedicated to delivering innovative health solutions for the prevention and treatment of diseases in humans and animals. This role is located at our purpose-built, agile small molecule manufacturing site in the United States.

• Provide deep technical operations leadership for small molecule drug substance manufacturing, including process engineering, scale‑up, validation, and troubleshooting.
• Serve as the site subject‑matter expert for equipment and facility issues and manage the intersection of process, product, equipment, and facility design.
• Own site‑level product introductions and technology transfer strategy, ensuring execution readiness, risk assessment, and control strategy alignment.
• Lead technical problem‑solving, resolve complex manufacturing challenges, support regulatory queries, and maintain GMP, data integrity, and audit readiness.
• Develop and monitor commercial performance, conduct technical risk reviews, implement preventive actions and drive continuous improvement.
• Build a culture of safety, scientific rigor, accountability, and continuous improvement, and lead workforce planning, succession planning, and capability development.
• Champion digital and analytics capabilities such as process data platforms, CPV analytics, and advanced modeling to enhance monitoring and decision‑making.
• Partner with Operations, Quality and other functions to embed transformation programs and new ways of working.

• 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 a 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 and audit leadership experience.
• Strong experience leading complex investigations and driving organizational transformation, including 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.

• Business Process Improvements
• Capital Management
• Change Management
• Chemical Process Development
• Cross‑Cultural Awareness
• Cross‑Functional Leadership
• Decision Making
• External Manufacturing
• GMP Compliance
• Innovation
• Manufacturing Scale‑Up
• Operational Excellence
• Operation Risk Management
• Process Improvements
• Process Safety
• Results‑Oriented
• Risk Assessments
• Stakeholder Communications
• Strategic Thinking
• Succession Planning
• Technical Issues
• Technology Transfer
• Transformational Leadership

• Current employee experience (preferred)
• Contingent worker experience (preferred)

San Francisco,California and Los Angeles,California.

Salary range: $ – $. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits package including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.