Scientist Vpp

Axle • Rockville, MD

9d • $105,000 - $115,000

About The Position

Axle is seeking a Scientist to support work at the National Institutes of Health (NIH) in Gaithersburg, Maryland. The role focuses on downstream process development and optimization for recombinant proteins, vaccines, mRNA, mRNA-LNP, and virus-like particles that may be used as clinical therapeutic or vaccine candidates. The Scientist will work within the purification group and collaborate with VPP departments, laboratory staff, and cross-functional Chemistry, Manufacturing, and Control (CMC) teams.

The position supports research experiments and clinical-trial vaccine candidates through pDNA linearization, mRNA in vitro transcription, chromatography, tangential-flow filtration, and normal-flow filtration. It also involves preparing and reviewing CMC materials for IND filings, technology-transfer and GMP-manufacturing documentation, and process batch records; supporting viral-clearance validation; generating mRNA-encapsulated material; interpreting and presenting research data; maintaining laboratory equipment and facilities; and training staff. The Scientist may serve as a functional lead or subject matter expert and present research at scientific meetings.

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 or tools, including column chromatography for protein purification (AEX, CEX, affinity, SEC, and HIC); column packing and testing; AKTA chromatography systems; lab-scale tangential-flow filtration systems; lab-scale nanofiltration systems; qualitative assays including SDS-PAGE and Western blot; and UV/visible spectrophotometers.
• 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, monoclonal antibodies, subunit or nanoparticle vaccines, mRNA, mRNA-LNP, and virus-like particles for potential clinical therapeutic or vaccine candidates.
• Design, develop, and optimize pDNA linearization, mRNA in vitro transcription, chromatography, tangential-flow filtration, and normal-flow filtration processes for clinical-trial vaccine candidates.
• Apply process optimization methods such as Design of Experiments (DoE) and other statistical design approaches.
• Support the planning and execution of research experiments within the laboratory’s research program.
• Write and 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 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 laboratory’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 preclinical studies.
• Compile and analyze data and present 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 in vitro transcription, chromatography, depth filtration, nanofiltration, and tangential-flow filtration 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, dependent care assistance, and transportation reimbursement

What This Job Offers

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