Position Overview

A PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required, along with a minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products.

Additional Qualifications

Certifications & Licenses

• PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required

   

Field of Study

• Biochemical Sciences

   

Software

• Familiarity with computer software including word processing and data evaluation

   

Skills

• Minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products is required

• Demonstrated knowledge of maintaining accurate and detailed records

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

• Strong oral and written communication skills

   

Deliverables

• Meet with lab members to present updates — Ad-Hoc

   

Statement of Work Details

• Oversee the development of downstream processes for VRC clinical candidates and the process tech transfer to the VCMP for clinical material generation for the VRC — 1

• Provide project support to lead scientists and/or associates to develop downstream process methods that meet the product quality and recovery characteristics to guarantee successful production of clinical material — 2

• Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle, including efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules — 3

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

• Supports laboratory staff on research projects and techniques

• Work with regulatory team, as needed, to support IND submissions and other requests

• Oversee viral clearance strategies in relevant downstream processes and direct the viral clearance validation efforts (SEC evaluation of CRO vendors, scale-down method SOP/validation approval, etc.)

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

• Train staff on the proper usage of laboratory instruments and equipment

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

• Coordinate closely with Manufacturing teams to ensure timely and scale-appropriate Technology Transfer is achieved by: writing/editing/reviewing tech transfer documents (Process Descriptions/Process Flow Diagrams) to support VCMP downstream process Master Batch Record authoring; serving as Person in Plant or assigning a team designee for initial VCMP production runs; serving as SME in VCMP downstream troubleshooting and facility fit calculations; and serving as the VRC downstream SME in external collaborations for projects outside of VCMP-path clinical development

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

• Responsible for planning and overseeing the downstream processes for toxicology lot material production, including editing/approving all process protocols, managing execution thereof, and generating production reports following successful campaigns

• Coordinates with junior staff to modify research protocols

• Presents research at national scientific meetings and symposia

• Encourage and drive innovation to meet new downstream challenges and seek to publicly distribute novel technologies through presentations at conferences and/or publication in peer-reviewed journals

• Provides interpretation of results, guidance, and scientific support to the management team

• Serve as a subject matter expert (SME) in guiding purification strategies for new vaccine or therapeutic mAb candidates (both internal to the downstream team and throughout the VPP)

• Mentors junior level scientists

• Work closely with Project Managers to ensure downstream milestones are appropriately set and met on time