Scientist, Engineering

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 biologic and vaccine products.  We seek a motivated scientist/engineer to work under technical direction of a group leader to support development and licensure of novel biologic and vaccine candidates and in-line products. In this role, you will be responsible for:

Primary Responsibilities

• Executing process development in large molecule downstream processing including lab-scale process development and optimization, in-process assay support, and process scale-up/scale-down model development.

• Leading the hands-on execution of lab-scale experiments and authoring associated technical reports and documents.

• Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing.

• Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.

• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.

• Participate in and drive organizational excellence practices such as technical standards, process platforms, operational procedures

Education Minimum Requirement:

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline with 2+ years of experience or Master’s Degree (non-thesis) with a minimum of 1 year of relevant experience in Chemical Engineering, Chemistry, Biology or comparable discipline.

Required Experience and Skills:

• Relevant academic, internship, co-op, or professional experience in a laboratory setting.

• Excellent oral and written communication skills.

• Hands-on expertise with downstream unit operations (i.e. membrane filtration, chromatography, etc.) and process development for large molecules

• Ability to understand and execute experiments independently in fulfillment of assigned program objectives in a manner that meets quality and timeline expectations

• Well-developed organizational, record-keeping, and problem solving skills, with an attention to detail

Preferred Experience and Skills:

• Experience within or collaboration with analytical teams, pilot-scale, and/or manufacturing environment.

• Large molecule drug substance process development, scaling (up and down) and technology transfer

• Current Good Manufacturing Practice (cGMP) awareness or experience. 

• Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.

• Communication of scientific information through oral presentations and written documents

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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