Senior Specialist, Engineering- Biologics External ManufacturingTechnicalOperations

Merck; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck's Large Molecule Technical Operations Unit seeks a Senior Specialist in Engineering to support drug substance technology transfer and commercial manufacturing with external partners in the biologics network. The role involves technical leadership, GMP documentation, process improvement, and on‑site partner coordination.

The position requires a Bachelor’s degree in a related field and 8+ years of GMP experience, with a preference for backgrounds in biologics or large molecule manufacturing.

Qualifications

• Bachelor's degree in a chemical/biochemical or related field.
• 8+ years of post-degree GMP experience or related roles.
• Experience with biologics or large molecule manufacturing preferred.

Responsibilities

• Lead technical interface between internal operations and external drug substance manufacturers on complex issues.
• Author and review GMP documentation including Master Batch Records, change controls, protocols, and regulatory filings.
• Manage technical activities for commercial manufacturing including change control, process improvement, and deviation investigation.
• Provide on-site support at external partners for commercial and technology transfer activities.
• Ensure external partners maintain inspection readiness and develop standardized GMP processes.

Skills

Technical leadership

GMP documentation

Process improvement

Root cause analysis

Risk assessment

Interpersonal communication

Independent work

Multi-tasking

Education

Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, Biology, or related field

Job description

Merck's Large Molecule Technical Operations Unit seeks a Senior Specialist in Engineering to support drug substance technology transfer and commercial manufacturing with external partners in the biologics network. The role involves technical leadership, GMP documentation, process improvement, and on‑site partner coordination.

Responsibilities

• Lead technical interface between internal operations and external partner drug substance manufacturers on complex issues
• Author and review GMP documentation including Master Batch Records, change controls, protocols, and regulatory filings
• Manage technical activities for commercial manufacturing including change control, process improvement, and deviation investigation
• Provide on‑site support at external partners for commercial and technology transfer activities
• Ensure external partners maintain inspection readiness and develop standardized work for GMP compliance

Requirements

• Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, Biology, or related field
• Minimum 8 years post-degree experience in GMP functional areas or support roles
• Strong analytical problem-solving, root cause analysis, and risk assessment capabilities
• Excellent interpersonal and professional communication skills
• Proven ability to work independently with strong organizational skills and multi-tasking abilities
• Experience in biologics or large molecule manufacturing (preferred)
• Knowledge of regulatory requirements and inspection support experience (preferred)

Compensation:

$117,000-$184,200 base