Director, Technical Operations - Biologics

Merck & Co.; Durham (NC); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with match

Paid holidays and vacation

Sick days and compassionate days

Job summary

Merck & Co. in Durham, NC seeks an Associate Director, Technical Operations to lead the drug substance manufacturing area as the company scales a new start-up facility.

You will mentor engineers and scientists, drive tech transfer, and oversee lifecycle activities from development through qualification to ensure quality and compliance. The role requires a strong background in aseptic processing and biologics, with a track record in GMP operations, risk management, and regulatory readiness.

Qualifications

• Bachelor's/Master's/Doctorate in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or related life science or engineering discipline.
• 4+ years (PhD), 6+ years (MS), or 7+ years (BS) in pharmaceutical ops/quality
• Strong decision-making, problem-solving and communication skills
• Aseptic GMP manufacturing experience, preferably with biological drug substance

Responsibilities

• Provide technical leadership to drug substance manufacturing as part of Technical Operations.
• Lead and coach engineers and scientists to support drug substance tech transfer and build a High-Performing Organization.
• Deliver end-to-end technical support across project lifecycle: risk mgmt, SOPs, MBRs, process development and PPQ.
• Lead cross-functional teams to address issues and achieve milestones.
• Review and approve project documents for drug substance, processes, and utilities.
• Act as SME for quality risk assessments and regulatory inspections.
• Support safety, environmental and compliance objectives.
• Escalate complex decisions to management as needed

Skills

API Manufacturing

Aseptic Processing

Biologics

Change Control Systems

Chemical Process Development

People Leadership

Regulatory Inspections

Regulatory Requirements

Cross-Functional Teamwork

Process Optimization

Technology Transfer

Safety & Compliance

Education

Bachelor's/Master's/Doctorate in chemical/biochemical/biological sciences or related engineering field

Tools

Lean Six Sigma

Job description

Merck & Co. in Durham, NC seeks an Associate Director, Technical Operations to lead the drug substance manufacturing area as the company scales a new start-up facility.

You will mentor engineers and scientists, drive tech transfer, and oversee lifecycle activities from development through qualification to ensure quality and compliance. The role requires a strong background in aseptic processing and biologics, with a track record in GMP operations, risk management, and regulatory readiness.