Scientist Vpp

Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field.

M.S. degree with ≥6 years relevant experience will be considered.

Miscellaneous Biology

Powerpoint

Outlook

Excel

Word

5-10 years of experience in industry-relevant recombinant protein process development for GMP clinical-phase products

Demonstrated knowledge of maintaining accurate and detailed records

Expertise in the following techniques or tools for protein and mRNA purification and characterization: Column chromatography for protein purification by means of AEX, CEX, affinity, SEC, HIC Column packing and testing AKTA chromatography system Lab scale TFF systems Lab scale nano-filtration systems Qualitative assays including SDS-PAGE and Western Blot UV/vis spectrophotometer

Must be a team player who can effectively work with members from cross-functional departments

Strong oral and written communication skills

Familiarity with computer software including word processing and data evaluation

Knowledge and use of statistical design of experiments (DoE)

Clean Equipment - Ad-Hoc

Meet with lab members to present updates - Ad-Hoc

Supports the planning and execution of research experiments in the context of the laboratory's overall research program.

Write and/or review appropriate CMC sections of IND filings (e.g. Process Description Summaries) to support VRC regulatory group.

Supports laboratory staff on research projects and techniques.

Work collaboratively with all VPP departments to coordinate schedules, material needs, and other deliverables to advance site-wide project goals.

Maintains laboratory equipment and the training of others in their use.

Support Viral Clearance Validation studies.

Purify research-phase recombinant proteins, virus vaccines, mRNA and/or virus-like particles in support of other groups at the VRC.

Assists in maintaining adequate space and facilities for ongoing and projected research studies.

Drive technology transfer of downstream processes to Lab’s Pilot Plant for manufacture of clinical product through document generation and on-site support.

Write and review technology transfer documents in support of GMP manufacturing.

Evaluates, analyzes and interprets research data, communicates results and methods in reports, presentations, and manuscripts.

Perform mRNA encapsulation to provide material generation for assay development and pre-clinical studies.

Analyze and compile data, present at various group/department meetings.

Write and review process batch records for toxicology batch productions.

Coordinates with junior staff to modify research protocols.

Serve as a functional lead and/or Subject Matter Expert (SME) in an inter-department Chemistry, Manufacturing, and Control (CMC) team with responsibilities for the following processes: in vitro transcription (IVT), chromatography, depth filtration, nano-filtration, and tangential-flow filtration (TFF).

Train associate scientists in the execution of chromatography, filtration processes, and other newly developed and/or novel production processes.

Presents research at national scientific meetings and symposia.

Present results of clinical and experimental research at recognized scientific meetings by lectures and exhibits (poster sessions).