Senior Principal Scientist, Global Analytical Transfer

Merck & Co.; West Point (PA); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Job summary

Merck & Co. in Rahway, NJ, USA, is seeking an Analytical Transfer specialist within Global Quality Large Molecule Analytical Sciences (GQ-LMAS).

The role focuses on late-stage method development, validation, and lifecycle management, with emphasis on global method transfer activities across vaccines and biologics. Ideal candidates will have strong cGMP experience, cross-functional collaboration skills, and a track record in analytical method transfers.

Qualifications

• Bachelor's degree in biology/chemistry/biochemistry with six years of relevant industry knowledge in development, validation, and/or QC.
• Master's degree with four years of relevant industry knowledge in development, validation, and/or QC.
• PhD with one year of relevant industry knowledge in development, validation, and/or QC.
• Knowledge of ICH, USP and compendial chapters required for method transfer and validation.
• Minimum two years in a cGMP-laboratory environment in large molecules (vaccines, biologics).
• Development and management of project timelines and deliverables.
• Participation in cross-functional project teams.
• Authoring and review of technical documents.

Responsibilities

• Lead complex analytical transfers for the team including ADCs, mAbs and Vaccines.
• Lead method transfers and/or validations across vaccine and biologics programs.
• Sponsor in-line and pipeline analytical methods and interface with network partners.
• Involvement in development, troubleshooting and optimization of analytical methods.
• Continuous improvement using lab standardization, lean methods, and six sigma.
• Assay lifecycle activities across large molecule franchises and platforms.
• Support regulatory filings and inspections with multiple agencies.

Skills

Analytical method transfer

cGMP-lab experience

Cross-functional teamwork

Project management

Technical writing

Risk assessment

Change control

Regulatory filings (IND/MAA/BLA)

Education

Bachelor's degree in biology/chemistry/biochemistry

Master's degree in biology/chemistry/biochemistry

PhD in biology/chemistry/biochemistry

Tools

ICH/USP knowledge

Job description

Merck & Co. in Rahway, NJ, USA, is seeking an Analytical Transfer specialist within Global Quality Large Molecule Analytical Sciences (GQ-LMAS).

The role focuses on late-stage method development, validation, and lifecycle management, with emphasis on global method transfer activities across vaccines and biologics. Ideal candidates will have strong cGMP experience, cross-functional collaboration skills, and a track record in analytical method transfers.