Biologics Downstream Scientist: Late-Stage Process Dev

Socket.dev

West Point (PA)

Hybrid

USD 87,000 - 137,000

Full time

2 days ago

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Job summary

Merck & Co., Inc. is seeking a Scientist/Engineer to join the Bioprocess Drug Substance Commercialization group.

You will lead downstream processing work for monoclonal antibodies, including lab-scale to pilot-scale development, scale-up/down modeling, and technology transfer support for in-line manufacturing. You will collaborate with commercial manufacturing teams, author technical documents for PPQ and licensure, and apply GMP practices in a fast-paced, cross-functional environment with

Qualifications

Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline.
2+ years of experience with downstream processing of mAb products or similar in lab/manufacturing, including membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance.
Mechanistic understanding of downstream processing separation sciences.
Ability to execute experiments independently in a manner that meets quality and timeline expectations.
Well-developed communication, organizational, and problem-solving skills, with an attention to detail.

Responsibilities

Lead the execution of hands-on experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and scale-up/down model development.
Collaborate with commercial manufacturing teams as a process sciences representative to support facility start-up and in-line support activities.
Author and/or review technical documents to support Process Performance Qualification (PPQ) and licensure.