Senior Tech Ops Lead Small Molecule Drug Product

Merck; Elkton (VA); On-site; USD 142,400 - 224,100; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

Vacation days

Sick days

Job summary

Merck in Elkton, Virginia seeks an Associate Director, Technical Operations for Small Molecule Drug Product to lead startup, tech transfer, validation, and commercial manufacture of oral solid dosage forms. You will provide technical leadership, drive process improvements, collaborate across Engineering, Quality, and Manufacturing, and ensure cGMP compliance from startup through lifecycle.

This role includes leading a team of engineers, managing CAPA, and guiding projects through capital

Qualifications

• Degree in Chemical Engineering, Pharmaceutics, or related field.
• 10+ years of experience in oral solid dose manufacturing, formulation, or process development.
• Strong background in process engineering and scale-up; validation.
• Working knowledge of cGMP manufacturing operations and regulatory expectations.
• Experience with deviation management and electronic batch records (DeltaV).

Responsibilities

• Provide technical leadership and oversight for oral solid dose manufacturing.
• Lead process scale-up, tech transfer, and validation activities (pre-PPQ, PPQ).
• Drive improvements in process performance, yield, robustness, and impurity control.
• Identify and mitigate risks with science-based solutions.
• Support technology transfer plans across internal sites and partners.
• Collaborate with Engineering, Capital Projects, R&D, Quality, and Manufacturing.
• Lead a team of engineers; oversee CAPA, investigations, and batch record readiness.

Skills

Chemical engineering

Pharmaceutical manufacturing

Process scale-up

cGMP knowledge

Leadership

Education

Degree in Chemical Engineering or related

Tools

DeltaV

Job description

Merck in Elkton, Virginia seeks an Associate Director, Technical Operations for Small Molecule Drug Product to lead startup, tech transfer, validation, and commercial manufacture of oral solid dosage forms. You will provide technical leadership, drive process improvements, collaborate across Engineering, Quality, and Manufacturing, and ensure cGMP compliance from startup through lifecycle.

This role includes leading a team of engineers, managing CAPA, and guiding projects through capital