Senior Biologics Tech Transfer & External Manufacturing

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Job summary

HireLifeScience seeks a Senior Specialist (Engineering) for Biologics External Manufacturing Technical Operations. The role focuses on tech transfer with external partners, maintaining GMP documentation, and supporting commercial manufacturing processes at external sites.

Ideal candidates have 8+ years in GMP environments, strong project management, and excellent communication skills to collaborate with operations, quality, and regulatory teams.

Qualifications

• Bachelor's degree required in chemical/biochemical engineering, pharmaceutical science, chemistry/biology or related field.
• Minimum of 8 years post-bachelor's GMP experience in Operations, Technical Operations, Technology or Engineering.
• Ability to work independently with strong organizational and communication skills.

Responsibilities

• Lead and act as the primary interface on technical issues between operations and external partner drug substance manufacturers.
• Oversee technical transfer activities including GMP documentation (Master Batch Records, change control, protocols, reports, qualifications).
• Manage technical activities for commercial manufacturing at external partner including change control, process improvements, and risk assessment.

Skills

Biologics

Deviation Management

DP Operations

Facility Design

GMP Compliance

Manufacturing

Process Validation

Project Management

Regulatory Compliance

Sterile Manufacturing

Technical Transfer

Independent Work

Technical Writing

Education

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

Job description

HireLifeScience seeks a Senior Specialist (Engineering) for Biologics External Manufacturing Technical Operations. The role focuses on tech transfer with external partners, maintaining GMP documentation, and supporting commercial manufacturing processes at external sites.

Ideal candidates have 8+ years in GMP environments, strong project management, and excellent communication skills to collaborate with operations, quality, and regulatory teams.