Scientist, Engineering

MSD • Rahway, NJ

2d • $87,300 - $137,400 • Onsite

About The Position

The Bioprocess Drug Substance and Commercialization (BDSC) group within our Manufacturing Division focuses on late-stage process development, technology transfer, and in-line support of biologics. We seek a motivated scientist/engineer to work under technical direction of a group leader to support development and licensure. In this role, you will be responsible for: Primary Responsibilities Leading the hands-on execution of experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development Collaborating 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 Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure

Requirements

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline with 2+ years of experience.
• Significant 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 unit operations
• Mechanistic understanding of downstream processing separation sciences
• Ability to understand and 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
• Collaboration with analytical teams, pilot-scale, and/or manufacturing environment
• 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

• Leading the hands-on execution of experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development
• Collaborating 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
• Authoring and/or reviewing 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
• annual bonus
• long-term incentive

What This Job Offers

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