Senior Biologics External Manufacturing Tech Lead

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

Job summary

MSD in West Point, PA seeks an experienced engineering professional to support drug substance tech transfer and commercial manufacture within our External Manufacturing Network. This role offers exposure to biologics or vaccines manufacturing and collaboration with key external partners to advance strategic initiatives.

You will lead technical transfer activities, author/review GMP documentation, drive process improvements, and ensure inspections at partner sites are met.

Qualifications

• Bachelor’s degree required in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry or Biology.
• Minimum of 8 years post-bachelor's degree experience in a GMP functional area or support of GMP operations.
• Ability to work independently with strong organizational and communication skills.
• Travel will be a requirement of this position at approximately 25%.

Responsibilities

• Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers.
• Responsible for technical transfer activities, including GMP documentation and regulatory filings.
• Provide on-site coverage at external partner in support of commercial and tech transfer activities.
• Develop solutions to complex technical issues with GMP compliance and validation.
• Translate GMP requirements into standardized work with operations, quality, and external partners.

Skills

Biologics

Deviation Management

DP Operations

Facility Design

GMP Compliance

Manufacturing

Manufacturing Operations

Manufacturing Process Validation

Project Management

Regulatory Compliance

Sterile Manufacturing

Technical Transfer

Working Independently

Writing Technical Documents

Education

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

Job description

MSD in West Point, PA seeks an experienced engineering professional to support drug substance tech transfer and commercial manufacture within our External Manufacturing Network. This role offers exposure to biologics or vaccines manufacturing and collaboration with key external partners to advance strategic initiatives.

You will lead technical transfer activities, author/review GMP documentation, drive process improvements, and ensure inspections at partner sites are met.