Scientist, Downstream – Biologics Drug Substance Commercialization

Merck • Upper Gwynedd Township, PA

3d • $87,300 - $137,400 • Hybrid

About The Position

We aspire to be the premier research-intensive biopharmaceutical company. Our manufacturing division is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases. We are seeking a motivated scientist/engineer to join our Bioprocess Drug Substance Commercialization (BDSC) group. This role offers an exciting opportunity to work on late-stage process development, technology transfer, and in-line support of biologics.

Requirements

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline.
• 2+ years of experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting, including unit operations such as 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.

Nice To Haves

• Large molecule drug substance technology transfer experience.
• Collaboration with analytical teams, pilot-scale, and/or manufacturing environments.
• Experience authoring technical documentation in support of the following: process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
• Current Good Manufacturing Practice (cGMP) awareness or experience.

Responsibilities

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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level