Associate Director/Director, Formulation & Downstream Process Development

About the role

A new stealth-mode biotech focused on in vivo gene editing.

Key Responsibilities

• Design, optimize, and execute downstream purification processes for targeted LNPs, with emphasis on SEC (gravity flow and column chromatography, including CIMmultus monolithic columns) and TFF (hollow fiber and flat sheet cassettes) at research and pilot scale.
• Develop and optimize TFF operating parameters including transmembrane pressure, cross-flow rate, membrane molecular weight cutoff selection, diafiltration volumes, and flux decay management to maximize product recovery and minimize particle stress.
• Establish SEC-based purification methods to separate assembled tLNP product from free protein, unincorporated lipid components, and process-related impurities; optimize resin selection, column loading, and elution conditions.
• Characterize downstream process intermediates and final drug product using DLS, zeta potential, nanoparticle tracking analysis (NTA), cryo-TEM, encapsulation efficiency assays, and protein/lipid quantitation methods.
• Evaluate and benchmark alternative and emerging purification modalities (e.g., bind-elute chromatography, membrane chromatography, depth filtration) for tLNP applications.
• Develop and optimize final formulation and buffer exchange conditions to ensure tLNP stability, including excipient screening, cryoprotectant selection, and lyophilization feasibility assessment.
• Lead process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs) for downstream unit operations.
• Support technology transfer of downstream processes to CDMOs, including process documentation (batch records, SOPs, technical reports), on-site support, and process troubleshooting.
• Collaborate with formulation scientists, analytical scientists, and biology teams to ensure downstream processes preserve LNP integrity, targeting ligand functionality, and cargo bioactivity.
• Design and execute process development studies using DOE approaches to systematically optimize purification and formulation parameters.
• Maintain detailed electronic laboratory notebooks and contribute to regulatory filings (IND/CTA) for downstream process and drug product CMC sections.
• Stay current with advances in nanoparticle purification, LNP downstream processing, and scalable manufacturing technologies.
• Provide scientific leadership for downstream process development strategy.
• Establish technical priorities across multiple programs.
• Partner cross-functionally with Formulation, Biology, Analytical, CMC, Manufacturing, and Regulatory.
• Represent downstream process development in technical and strategic discussions.

Qualifications

• PhD. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Chemistry, Biochemistry, or a related field with 15+ years of industry experience; or M.S. with 8+ years of relevant industry experience, or B.S. with 10+ years of relevant experience.
• Demonstrated hands-on expertise in TFF process development for nanoparticle or biopharmaceutical applications, including membrane selection, process optimization, and scale-up.
• Direct experience with SEC or chromatographic purification of lipid nanoparticles, liposomes, or related colloidal drug delivery systems.
• Strong understanding of LNP formulation and characterization, including DLS, zeta potential, cryo-TEM, encapsulation efficiency, and particle stability assessment.
• Experience defining CPPs and CQAs for downstream processes and contributing to process characterization and validation.
• Proficiency with DOE-based experimental design and statistical analysis of process development data.
• Excellent scientific communication skills, including technical report writing, SOPs, and presentation of data to cross-functional teams.
• Ability to work independently in the lab, manage multiple projects, and mentor junior scientists.
• Demonstrated experience leading scientific programs and influencing cross-functional teams.
• Experience mentoring and developing scientists.
• Ability to establish technical strategy while remaining an active scientific contributor.

Preferred Qualifications

• Direct experience with targeted or functionalized nanoparticle purification, including separation of decorated particles from free targeting ligands (e.g., antibodies, peptides, aptamers).
• Experience with monolithic column chromatography (e.g., CIMmultus) or membrane chromatography for nanoparticle purification.
• GMP manufacturing experience for LNP or liposomal drug products, including process validation, batch record authoring, and deviation investigation.
• Experience with AAV or viral particle purification and characterization.
• Experience with lyophilization process development for nanoparticle formulations.
• Familiarity with regulatory requirements for CMC sections of gene therapy INDs (ICH Q8–Q12) and experience supporting technology transfer to CDMOs.
• Track record of scientific publications and/or patents in LNP purification, downstream processing, or nanoparticle formulation.