This role pays less than
67%
of similar roles. Most pay
$208,300–$273,987
— the shaded band above.
At the midpoint, this role pays about
$223k
versus about
$241k
for comparable roles.
Based on 240 similar postings.
Employer
About MSD
MSD (Merck Sharp & Dohme) is the international name for Merck & Co., a major U.S.-based pharmaceutical company.
MSD currently has
15 open roles
on FindRole.
Listed pay typically runs
$117,000–$184,200
across 15 roles with salary data.
Director, Engineering - Technical Operations leads the Technical Operations Department at a high-potent biologic manufacturing facility. This role serves on the Site Leadership Team, where the incumbent develops strategic manufacturing roadmaps, manages departmental budgets, and oversees process engineering, site validation, technical support, and technical transfer activities. The position involves managing the lifecycle of potent drug substances and drug products, including Antibody Drug Conjugates, while ensuring compliance with cGMP standards. Day-to-day responsibilities include recruiting and mentoring a high-performing team, overseeing facility startup, and coordinating new product introductions with cross-functional partners in quality, supply chain, and regulatory affairs. The role requires expertise in manufacturing scale-up, root cause analysis, and risk management to ensure reliable supply of cytotoxic and non-cytotoxic compounds. Key skills include technical leadership, project management, and experience with complex process validation and regulatory inspection preparedness.
Develop and execute the strategic manufacturing and technical roadmap for the Wilmington Biotech facility.
Lead the Technical Operations team through recruitment, talent development, and performance management.
Manage the end-to-end lifecycle of product commercialization, including technology transfer and routine clinical operations.
Oversee process validation, equipment qualification, and monitoring strategies to ensure cGMP compliance.
Manage department budgets, financial planning, and resource allocation for technical projects.
Partner with cross-functional teams to manage new product introductions and regulatory filing preparations.
Drive continuous improvement initiatives by leading root cause investigations and implementing corrective actions.
Provide technical oversight for the manufacturing of potent drug substances and antibody drug conjugates.
What we're looking for
A degree in Engineering, Science, Technical, or another relevant field is required.
Candidates must have 12 years of experience with a Bachelor's, 10 years with a Master's, or 8 years with a PhD.
Demonstrated leadership experience managing and mentoring high-performing cross-functional teams is required.
Experience in manufacturing and providing technical oversight for biologic products including potent drug substances and drug products under GMP standards is required.
Experience in new facility operational readiness, equipment/process design, and operation ramp-up is required.
Experience in New Product Introduction, Technical Product Transfer, and investigation or change management is required.
Experience in regulatory inspection preparedness and preparing global regulatory submissions like BLAs and NDAs is required.
Operations experience in manufacturing potent drug substances or sterile products at pilot/commercial scale (preferred); knowledge of ADC analytical methods (preferred).
Remote (Wilmington, DE)10 days ago
$142,400–$224,100
cGMP
Computer System Validation
CSV
IQ
OQ
FAT
SAT
Commissioning
Qualification
Cleaning Validation
VHP
Six Sigma
FMEA
Process Performance Qualification
Tech Transfer
Aseptic Process Simulation
Lyophilization
Chromatography
high-potency manufacturing
Remote (West Point, PA)8 days ago
$117,000–$184,200
Biologics
Cell Culture
cGMP
Process Development
Upstream Processing
Design of Experiments (DOE)
Technology Transfer
Mammalian Cell Culture
Chromatographic Techniques
Quality by Design (QbD)
Lean Six Sigma
Regulatory Submissions
IND
MAA
BLA
Statistical Data Analysis
GMP
Process Validation
Equipment Qualification
Root Cause Analysis
Lean Six Sigma
Project Management
Pharmaceutical Packaging
Medical Device Assembly
Technology Transfer
Process Design
Scale-up
Regulatory Compliance
Robotics
Motion Control
Automation
Systems Engineering
Atmospheric Systems
Control Systems
Mechanical Engineering
Electrical Engineering
Risk Analysis
Verification and Validation
Software Interface