Scientist Vpp

Axle • Rockville, MD

8d • Onsite

About The Position

Axle is seeking a Scientist to support work at the National Institutes of Health (NIH) in Gaithersburg, Maryland. The role develops downstream processes for recombinant proteins and other clinical therapeutic or vaccine candidates, including monoclonal antibodies, subunit or nanoparticle vaccines, mRNA, mRNA-LNP, and virus-like particles. The Scientist works independently and collaboratively within the purification group and with cross-functional VPP departments, supporting research, clinical-trial candidates, regulatory documentation, and GMP manufacturing technology transfer.

The position also supports laboratory research planning and execution, equipment maintenance, staff training, data analysis and reporting, and preparation of CMC and technology-transfer documents. The Scientist may serve as a functional lead or subject matter expert on an interdepartmental Chemistry, Manufacturing, and Control (CMC) team and present research findings at meetings and scientific conferences.

Requirements

• Ph.D. in Chemical Engineering, Biology, Chemistry, or a related life sciences field; an M.S. degree with at least 6 years of relevant experience will be considered.
• 5–10 years of industry-relevant recombinant protein process development experience for GMP clinical-phase products.
• Demonstrated knowledge of maintaining accurate and detailed records.
• Expertise in protein and mRNA purification and characterization techniques, including column chromatography using AEX, CEX, affinity, SEC, and HIC.
• Experience with column packing and testing.
• Experience with AKTA chromatography systems.
• Experience with lab-scale TFF systems and lab-scale nano-filtration systems.
• Experience with qualitative assays, including SDS-PAGE and Western blot.
• Experience using a UV/vis spectrophotometer.
• Ability to work effectively as a team member with cross-functional departments.
• Strong oral and written communication skills.
• Familiarity with word-processing and data-evaluation software.
• Knowledge and use of statistical design of experiments (DoE).

Responsibilities

• Develop downstream processes, with minimal oversight, for recombinant proteins and other potential clinical therapeutic or vaccine candidates.
• Design, develop, and optimize pDNA linearization, mRNA in vitro transcription (IVT), chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for clinical-trial vaccine candidates.
• Apply process optimization methods such as Design of Experiments (DoE) or other statistical design approaches.
• Support the planning and execution of research experiments within the laboratory's research program.
• Write and/or review appropriate CMC sections of IND filings, including process description summaries, to support the VRC regulatory group.
• Support laboratory staff on research projects and techniques.
• Coordinate schedules, material needs, and other deliverables with VPP departments to advance site-wide project goals.
• Maintain laboratory equipment and train others in its use.
• Support viral clearance validation studies.
• Purify research-phase recombinant proteins, virus vaccines, mRNA, and/or virus-like particles for other VRC groups.
• Help maintain adequate space and facilities for ongoing and projected research studies.
• Drive technology transfer of downstream processes to the Lab’s Pilot Plant through document generation and on-site support.
• Write and review technology-transfer documents for GMP manufacturing.
• Evaluate, analyze, and interpret research data; communicate results and methods in reports, presentations, and manuscripts.
• Perform mRNA encapsulation to generate material for assay development and pre-clinical studies.
• Analyze and compile data and present it at group and department meetings.
• Write and review process batch records for toxicology batch productions.
• Coordinate with junior staff to modify research protocols.
• Serve as a functional lead and/or subject matter expert on an interdepartmental CMC team for IVT, chromatography, depth filtration, nano-filtration, and TFF processes.
• Train associate scientists in chromatography, filtration, and other newly developed or novel production processes.
• Present research at national scientific meetings and symposia, including through lectures and poster sessions.
• Clean equipment on an ad-hoc basis.
• Meet with laboratory members to present updates on an ad-hoc basis.

Benefits

• 100% medical, dental, and vision coverage for employees
• Paid time off and paid holidays
• 401(k) match up to 5%
• Educational benefits for career growth
• Employee referral bonus
• Flexible spending accounts, including healthcare FSA, parking reimbursement (PRK), dependent care assistance (DCAP), and transportation reimbursement (TRN)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree