Scientist

Axle Informatics•Rockville, MD

About The Position

Axle is looking to add a driven, flexible, organized, and meticulous Scientist to our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Vaccine Research Center (VRC), Vaccine Production Program (VPP) Downstream group, and management of process development processes.

Requirements

PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required.
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.
Familiarity with computer software including word processing and data evaluation.

Responsibilities

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.
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.
Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle. This includes efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules.
Work closely with Project Managers to ensure downstream milestones are appropriately set and met on time.
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).
Responsible for planning and overseeing the downstream processes for toxicology lot material production. This includes editing/approving all process protocols, managing execution thereof, and the generation of production reports following successful campaigns.
Coordinate closely with Manufacturing teams to ensure timely and scale appropriate Technology Transfer is achieved, by pursuing the following: Write/edit/review tech transfer documents (Process Descriptions/Process Flow Diagrams) to support VCMP downstream process Master Batch Record authoring. Serve as Person in Plant or assigns team designee for initial VCMP production runs. Serve as SME in VCMP downstream troubleshooting and facility fit calculations.
Serve as the VRC downstream SME in external collaborations for projects outside of VCMP-path clinical development
Work with regulatory team, as needed, to support IND submissions and other requests.
Oversee viral clearance strategies in relevant downstream processes and directs the viral clearance validation efforts (SEG evaluation of CRO vendors, scale-down method SOP/validation approval, etc.
Encourage and drive innovation to meet new downstream challenges and seeks to publicly distribute novel technologies through presentations at conferences and/or publication in peer- reviewed journals.