Position Summary
We are seeking an Engineer / Scientist to support drug product process development, process characterization, technology transfer, and manufacturing support for targeted lipid nanoparticle (tLNP) drug product processes. This role will focus on transferring complex LNP manufacturing processes to CDMOs, building and maintaining process models, supporting scale-up and process performance monitoring, and leading technical assessments for deviations, investigations, and process improvements.
The ideal candidate has hands-on experience with biologics, nanoparticle, RNA, sterile drug product, or advanced therapy manufacturing processes and is comfortable working across process development, analytical data, manufacturing execution, and quality systems.
Key Responsibilities
Process Development
- Support process optimization and characterization activities for LNP formulation, TFF, mAb sterile filtration, and final fill.
- Support definition and refinement of CPPs, KPPs, CMAs, IPCs, IPTs, and release-relevant process controls.
- Collaborate with Analytical Development, Quality, Manufacturing, Supply Chain, Regulatory, and external partners to ensure process knowledge is captured and applied consistently.
Technology Transfer to CDMOs
- Lead LNP/tLNP drug product unit operations to external manufacturing partners, including formulation, TFF/UF-DF, conjugation, sterile filtration, and final fill.
- Role will communicate and align internal process knowledge to CDMO’s through development of process descriptions and ensure alignment on CPPs, KPP, CMAs, equipment fit, single-use assembly design, and hold times. Review documentation from CDMOs surrounding batch execution at all relevant scales.
- Review executed batch records, deviations, process data, and analytical results to confirm process performance and identify improvement opportunities.
- Provide person-in-plant or remote technical support
Process Modeling & Data Analysis
- Develop and maintain process models for mass balance, IPCs/IPTs, and process parameters. Use process models to support scale-up, tech transfer, batch planning, deviation impact assessments, and manufacturing readiness.
- Support continued process verification by identifying trends, process drifts, and relationships between process inputs and product quality attributes.
Required Qualifications
- 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, technical operations, or GMP manufacturing support.
- Experience with biologics, RNA, LNPs, nanoparticles, sterile drug product, vaccines, cell/gene therapy, or other complex parenteral products.
- Experience supporting CDMO manufacturing campaigns, engineering runs, GMP batches, GLP tox batches, or clinical supply manufacturing.
- Ability to analyze process data and build mass balance or process models using Excel, JMP, Python, MATLAB, Spotfire, or similar tools.
- Strong technical writing skills with experience authoring technical reports, deviation assessments, process descriptions, or transfer documentation.
- Ability to work cross-functionally with internal teams and external CDMOs in a fast-paced development environment.
Preferred Qualifications
- Experience with process risk assessments, FMEA, continued process verification, process characterization, or control strategy development.
- Familiarity with GMP documentation, change control, CAPA, deviation systems, and regulatory expectations for biologics or sterile drug products.
Salary Range: $130,000 - $150,000
Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.
