Senior Leader, Biologics Downstream Processing

Merck & Co.

West Point (PA)

On-site

USD 173,000 - 273,000

Full time

5 days ago

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Benefits offered by this job

Medical insurance

Dental and Vision

401(k) plan

Paid holidays

Vacation and sick days

Job summary

Merck & Co. is seeking a Principal Scientist (Director) to lead the Biologics Downstream team within BDSC-Downstream. You’ll guide late-stage programs, develop strategies, and mentor scientists while collaborating across Manufacturing, Quality, and Regulatory groups.

The role focuses on downstream processing, tech transfer, and regulatory support to enable global manufacturing and commercialization of biologics products.

Qualifications

Deep expertise in downstream processing of biologics.
Independently design, direct, execute and document PD studies.
Experience supporting late-stage development and commercialization.

Responsibilities

Lead downstream teams supporting late-stage and commercial programs.
Provide technical leadership for lab to manufacturing scale studies.
Serve as SME across core unit operations and interdependencies.
Drive transfer activities, scale-up, validation and readiness.
Author/regulatory documentation for submissions and updates.
Mentor and coach downstream scientists; foster scientific rigor.

Skills

Downstream Processing

Biologics

Process Development

Technology Transfer

Team Leadership

Regulatory Submissions

Cross-Functional Collaboration

GMP

Analytical Thinking

Strategic Thinking

Education

BS/MS/PhD in Chemical/Biological Engineering or related

Tools

Regulatory Documentation

Job description

The role focuses on downstream processing, tech transfer, and regulatory support to enable global manufacturing and commercialization of biologics products.

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