Technical Operations Lead, Small Molecule Drug Product

MSD; Elkton (MD); On-site; USD 180,000 - 240,000; Full time

Job summary

MSD in Elkton, VA is seeking an Associate Director, Technical Operations – Small Molecule Drug Product to lead technical activities across startup, transfer, validation, and ongoing commercial manufacture of oral solid dosage forms. The role emphasizes safe, compliant, and reliable process performance with lifecycle management.

You will drive continuous improvement, collaborate with cross-functional teams, and guide engineering, R&D, Quality, and Manufacturing to optimize productivity and

Qualifications

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related field.
• Typically 10+ years of relevant experience in biopharma manufacturing.
• Strong analytical and problem-solving skills.
• Experience with capital projects, CQV, and facility startup.

Responsibilities

• Provide technical leadership and oversight for drug product operations (oral solid dosage).
• Lead technology transfer, scale-up, qualification, and startup readiness for new processes.
• Drive operational excellence, process improvements, and CAPA across assigned processes.
• Ensure regulatory compliance (cGMP) and support inspections and filings.
• Lead cross-functional teams with Engineering, Quality, Supply Chain, and Manufacturing.
• Support recruitment, team development, and departmental planning.

Skills

Analytical skills

Problem solving

Cross-functional collaboration

Capital projects experience

Education

Degree in Chemical Engineering / Pharmaceutics / Pharmaceutical Sciences

Tools

CQV knowledge

Facility startup experience

Job description

MSD in Elkton, VA is seeking an Associate Director, Technical Operations – Small Molecule Drug Product to lead technical activities across startup, transfer, validation, and ongoing commercial manufacture of oral solid dosage forms. The role emphasizes safe, compliant, and reliable process performance with lifecycle management.

You will drive continuous improvement, collaborate with cross-functional teams, and guide engineering, R&D, Quality, and Manufacturing to optimize productivity and