Associate Director, Technical Operations (Drug Product)

Merck•Elsmere, DE

1d•Hybrid

About The Position

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE! We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact. Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time. In this position the Technical Operations Associate Director will play a pivotal role in ensuring oversight of various aspects of manufacturing, change management and technology transfer of programs to the site. In partnership with site manufacturing team will provide comprehensive manufacturing and technical leadership to the DP organization supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.

Requirements

Bachelor’s degree in engineering, science or related discipline.
Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
Previous experience of manufacturing and technical support of shakedown batches, engineering batches, developmental batches and PPQ runs.
Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
Ability to adapt to changing priorities as project demands change.
Demonstrated skills in planning, communication (oral and written) and technical writing.
Antibody Drug Conjugates (ADC)
API Manufacturing
Change Control Systems
Change Management
Change Request Management
Chemical Process Development
Cross-Cultural Awareness
Cross-Functional Teamwork
Detailed Design
Equipment Qualification
GMP Compliance
Hazard Analysis
Manufacturing
Manufacturing Process Validation
Operational Acceptance Testing (OAT)
People Leadership
Pharmaceutical Manufacturing
Process Characterization
Process Hazard Analysis (PHA)
Process Optimization
Production Supervision
Regulatory Inspections
Regulatory Requirements
Results-Oriented

Nice To Haves

Start-up experience in a large-scale commercial drug product facility highly desirable with hands-on experience with antibody drug conjugates highly preferred.
Expertise in drug product filling and lyophilization operations will be advantageous.
Previous experience with CQV activities will be advantageous.

Responsibilities

Lead and engage with the engineering design firms in detailed design on all aspects of drug product manufacturing.
Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
Develop project appropriate guidance documents as necessary.
Execute automation sprints as necessary in the drug product area.
Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
Provide Manufacturing and Technical expertise to the manufacturing team and leadership of the Technical Operations team, including areas such as formulation, filling, isolators, lyophilization and aseptic processing.
Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
Provide technical leadership for new product introductions (Tech Transfer).
Support technical deliverables within Drug Product to support the successful product launch.
Provide manufacturing and technical support for RFT implementation and execution.
Communicate complex technical issues to stakeholders, external customers, agencies.