Senior Engineer, Drug Product

Responsibilities

• Support process optimization and characterization for LNP formulation, TFF, mAb sterile filtration, and final fill
• Lead LNP/tLNP drug product unit operations to external manufacturing partners (CDMOs)
• Communicate internal process knowledge to CDMOs through process descriptions and alignment on CPPs and equipment fit
• Review executed batch records, deviations, and analytical results to confirm performance
• Develop and maintain process models for mass balance, IPCs/IPTs, and process parameters
• Support continued process verification by identifying trends and process drifts

Requirements

• BS with 6+ years of relevant experience or MS with 4+ years of relevant experience
• Advanced degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or related field
• Experience in process development, manufacturing sciences, or GMP manufacturing support
• Experience with biologics, RNA, LNPs, nanoparticles, or sterile drug products
• Experience supporting CDMO manufacturing campaigns or clinical supply manufacturing
• Ability to build mass balance or process models using Excel, JMP, Python, MATLAB, or Spotfire
• Strong technical writing skills for reports, deviation assessments, and transfer documentation

Preferred Qualifications

• Experience with process risk assessments, FMEA, or control strategy development
• Familiarity with GMP documentation, change control, CAPA, and deviation systems

About the Company

Sail Biomedicines is an Equal Opportunity Employer focused on advancing drug product processes for targeted lipid nanoparticle (tLNP) technologies.