Senior Scientist, Engineering

Job Description

As part of Our Company’s Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bio separation Sciences (BSS) department provides the technical downstream process leadership and laboratory capabilities in support of late stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics. BDSC supports second generation process development and various commercialization activities including process characterization, process science support for technology transfer to internal and external manufacturing sites, manufacturing investigation, process validation, and authoring of regulatory submissions.  

Under the general scientific and administrative direction of the technical leader in downstream and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule programs within BDSC. This individual will demonstrate scientific and experimental skills focusing on downstream processing.  

Technical Scope

• Participates in teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization. 

• Responsible for laboratory-scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. 

• Provides technical leadership for the design of experiments, data analysis and interpretation, as well as the execution of (internal) or management of (external) laboratory activities.

• Primary focus will be on downstream processing, but with an emerging knowledge of the various aspects of drug substance manufacture and functional area interdependencies, including cell culture, analytical, and site readiness. 

• Actively interacts with internal and external partners. May represents functional area on cross-functional teams.

• Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to our Company standard practices.

Education Minimum Requirement:

• BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6 years (for BS) or 4 years (for MS) relevant experience. PhD candidates with 0+ year(s) of relevant experience will also be considered.

Required Experience and Skills:

• Technical background in purification of biological molecules (including multi-specific antibody variants), including laboratory models for chromatography and filtration systems. 

• Hands on experience in small scale laboratory downstream process.

• Strong fundamental knowledge in downstream processing of biologics.

• Excellent oral and written communication skills. Demonstrated ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.

Preferred Experience and Skills:

• Experience with downstream purification of biological molecules (including multi-specific antibody variants) required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated …