Director, Technical Operations (Small Molecule Drug Product)

Director and Technical Operations Leader (Small Molecule Drug Product)

Technical Operations Subject Matter Expertise
- Lead small molecule drug product manufacturing operations (equipment, facility/infrastructure systems, site operations, process engineering, scale-up, validation, troubleshooting).
- Serve as site SME for equipment and facility-related technical issues.
- Manage the intersection of process, product, equipment, and facility design for robust, reliable performance.
- Align approaches across similar equipment/processes with the broader technical operations network.
- Support industrialization of new technologies and scientific advances.

Product Introduction, Technology Transfer, and Execution Readiness
- Own site product introductions and technology transfer strategy/execution, including receiving unit responsibilities.
- Partner with product science for end-to-end risk assessment, control strategy alignment, and on-time right-first-time introductions.
- Ensure readiness via process stewardship and operational risk management.
- Evaluate scale-up strategies, process performance robustness, and manufacturability.

Technical Problem Solving and Compliance Leadership
- Resolve technical challenges to sustain supply; support regulatory technical queries.
- Lead with strong GMP, data integrity, and audit readiness mindset.
- Escalation point for complex, multi-site technical issues; provide authoritative evidence-based responses for inspections/audits.

Technical Performance and Continuous Improvement
- Monitor performance trends and drive preventive actions.
- Lead technical risk reviews and timely mitigations.
- Use technical/operational data to inform prioritization and investment.
- Feed production insights back into development/network strategies.

People/Transformational Leadership
- Build safety, scientific rigor, accountability, continuous improvement, inclusive leadership, and team capability.
- Ensure workforce planning, succession planning, and capability-building.
- Champion business process improvement, integrating digital/data-enabled methods while maintaining compliance/data integrity.
- Sponsor digital/analytics capabilities (e.g., process data platforms, CPV analytics).
- Lead portfolio prioritization, resource allocation, and governance.
- Communicate effectively and drive results through team leadership.

Qualifications
- Bachelor’s (preferably Science/Engineering).
- 10+ years in small molecule drug product process/development and/or manufacturing technical operations.
- 7+ years with advanced degree in Chemistry, Chemical Engineering, or related discipline.
- Track record in new product introduction, tech transfer, PPQ, commercial scale-up, process validation, and lifecycle management.
- Knowledge of GMP, ICH, process safety, Quality Systems; inspection readiness leadership.
- Strong experience leading complex investigations; evidence of transformation.
- Exceptional stakeholder management; ability to lead through ambiguity/across geographies; prior site portfolio responsibility.

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

Application
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).