Director, Engineering - Technical Operations
Merck
August 25, 2026
On-site
Wilmington, DE
Operations
Technical Operations Director
Responsibilities / Accountabilities
- Lead the site Technical Operations team; recruit, manage, and develop talent; build quality culture and succession plans.
- Manage department resources, performance, and day-to-day execution; develop annual operations financial plans and quarterly adherence guidance.
- Provide technical leadership for commercialization, technology transfer, manufacturing, filing, and licensing of potent DS/DP (including ADCs); sustain validated state post-transfer.
- Provide key input for facility startup (facility/process/equipment/logistics/utilities) and establish systems for routine manufacturing of cytotoxic and non-cytotoxic compounds via validation, operational readiness, and product launch.
- Implement operating policies/procedures/budget to enable right-first-time execution and high-quality product delivery.
- Partner cross-functionally (Operations, Quality, Supply Chain, Global S&T, R&D, GES, Regulatory) on NPI and regulatory filings.
- Design and oversee process validation/qualification/monitoring strategies (master validation plans).
- Benchmark performance and share best practices across the network; champion routine product performance/health assessments.
- Execute and improve validation programs (cGMP compliance); drive scientific/technological improvement opportunities and cost/quality improvements.
- Support technical CAPA (investigations, root cause, corrective/preventive actions, change management/Kaizen).
- Provide direct technical support (raw materials/suppliers, process fit, campaign prep/follow-ups; safety/HAZOP, monitoring, investigations; cleaning process development and documentation review).
Qualifications / Experience
- Degree in Engineering/Science/Technical or related field: Bachelor’s +12 years, or Master’s +10 years, or PhD +8 years.
- 6+ years leadership experience managing/coaching cross-functional teams.
- Strong GMP background overseeing biologics manufacturing for potent DS/DP (ADCs).
- Experience with new facility operational readiness and ramp-up (organization, people, operations management systems).
- Experience in New Product Introduction, technical transfer, manufacturing process, and investigation/change management.
- Regulatory inspection preparedness; prepare/review global regulatory submissions (e.g., BLAs/NDAs).
Preferred Skills / Experience
- Operations experience for potent drug substance and/or sterile drug products (pilot/commercial).
- ADC commercialization experience through PPQ and launch.
- Knowledge of analytical methods and ADC product attributes.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Responsibilities / Accountabilities
- Lead the site Technical Operations team; recruit, manage, and develop talent; build quality culture and succession plans.
- Manage department resources, performance, and day-to-day execution; develop annual operations financial plans and quarterly adherence guidance.
- Provide technical leadership for commercialization, technology transfer, manufacturing, filing, and licensing of potent DS/DP (including ADCs); sustain validated state post-transfer.
- Provide key input for facility startup (facility/process/equipment/logistics/utilities) and establish systems for routine manufacturing of cytotoxic and non-cytotoxic compounds via validation, operational readiness, and product launch.
- Implement operating policies/procedures/budget to enable right-first-time execution and high-quality product delivery.
- Partner cross-functionally (Operations, Quality, Supply Chain, Global S&T, R&D, GES, Regulatory) on NPI and regulatory filings.
- Design and oversee process validation/qualification/monitoring strategies (master validation plans).
- Benchmark performance and share best practices across the network; champion routine product performance/health assessments.
- Execute and improve validation programs (cGMP compliance); drive scientific/technological improvement opportunities and cost/quality improvements.
- Support technical CAPA (investigations, root cause, corrective/preventive actions, change management/Kaizen).
- Provide direct technical support (raw materials/suppliers, process fit, campaign prep/follow-ups; safety/HAZOP, monitoring, investigations; cleaning process development and documentation review).
Qualifications / Experience
- Degree in Engineering/Science/Technical or related field: Bachelor’s +12 years, or Master’s +10 years, or PhD +8 years.
- 6+ years leadership experience managing/coaching cross-functional teams.
- Strong GMP background overseeing biologics manufacturing for potent DS/DP (ADCs).
- Experience with new facility operational readiness and ramp-up (organization, people, operations management systems).
- Experience in New Product Introduction, technical transfer, manufacturing process, and investigation/change management.
- Regulatory inspection preparedness; prepare/review global regulatory submissions (e.g., BLAs/NDAs).
Preferred Skills / Experience
- Operations experience for potent drug substance and/or sterile drug products (pilot/commercial).
- ADC commercialization experience through PPQ and launch.
- Knowledge of analytical methods and ADC product attributes.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).