Scientist, Engineering - Biologics Downstream Commercialization Process Sciences

Job Description

Position Description:

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

Education Minimum Requirement:

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline with 3+ 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

Preferred Experience and Skills:

• 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

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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Effective September