Scientist, Engineering Full-time NEW

Bioprocess Drug Substance And Commercialization Scientist/Engineer

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

Position Qualifications :

Education Minimum Requirement:

• Bachelor's Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline with 2+ years of experience.

Required Experience and Skills:

• 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

Required Skills:

Clinical Manufacturing, Data Analysis, Detail-Oriented, Downstream Process Development, Experimentation, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Technical Writing, Technology Transfer, Writing Technical Documents

Salary Range for this role is $87,300.00 – $137,400.00