Biologics Process Analytics Lead for Commercialization

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

Benefits offered by this job

Medical, dental, vision insurance

Retirement benefits (401(k))

Paid holidays and vacation

Job summary

Merck & Co., Inc. in Rahway, NJ, USA seeks a senior Process Analytics leader to guide analytical development across drug substance and product teams.

The role provides scientific leadership, drives process development and commercialization activities, and mentors a high-performing team in a fast-paced environment. The candidate will ensure regulatory readiness, collaborate with cross-functional partners, and promote data-driven problem solving and exceptional scientific rigor throughout the

Qualifications

• Bachelor-level or higher with strong analytical background and scientific judgment.
• Ability to guide and troubleshoot across teams with strong communication.

Responsibilities

• Provide scientific leadership to Process Analytics team and standardize efforts.
• Guide routine testing teams and enable robust data analysis.
• Collaborate with drug substance/product teams and analytical network.
• Prioritize testing across multiple projects in a dynamic environment.
• Oversee development and transfer of new analytical methods.
• Draft protocols, reports, and regulatory documents for comparability studies.
• Maintain high standards of ethics, compliance, and documentation.
• Support lab lead and foster a collaborative team culture.

Skills

Adaptability

Analytical Thinking

Biologics

Bioreactors

cGMP Regulations

Chemical Engineering

Chemistry

Chromatographic Techniques

Process Development (PD)

Process Scale Up

Regulatory Submissions

Cross-Functional Project Management

Data Analysis Tools

Education

Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, Analytical Chemistry, Chemistry or a related field

Tools

Empower

Job description

Merck & Co., Inc. in Rahway, NJ, USA seeks a senior Process Analytics leader to guide analytical development across drug substance and product teams.

The role provides scientific leadership, drives process development and commercialization activities, and mentors a high-performing team in a fast-paced environment. The candidate will ensure regulatory readiness, collaborate with cross-functional partners, and promote data-driven problem solving and exceptional scientific rigor throughout the