Overview In this role you will lead the design and execution of scalable LVV downstream purification strategies to support ex vivo and in vivo applications. You will steer cross functional teams to deliver IND enabling, clinical, and commercial processes while ensuring quality, yield, and robustness. The position partners with Regulatory, CMC, Manufacturing, and external CDMOs to drive clean, compliant downstream solutions. You will shape process characterization, tech transfer, and continuous improvement to advance our gene therapy portfolio. This is a high impact, leadership role in a fast moving cell therapy program.
Compensation / Benefits- 401(k) plan
- paid vacation and holidays
- paid leaves
- health benefits (medical, prescription, dental, vision)
- short-term incentive bonus opportunity
- equity-based long-term incentive program
Responsibilities- Define and execute end to end LVV downstream strategies focused on yield, purity, potency, consistency, scalability, and cost
- Establish phase appropriate purification processes for IND, clinical, and commercial manufacturing
- Provide technical oversight across clarification, chromatography, UF/DF (TFF), and sterile filtration operations
- Lead matrixed project teams, align technical strategy, timelines, and decisions
- Coach scientists and engineers, ensure high quality experimental design and data interpretation
- Design and qualify scale down models and support scale up to pilot and commercial equipment
- Author/approve technology transfer packages and enable successful implementation at GMP sites and CDMOs
- Contribute to CMC downstream development strategies, control strategy, and in process monitoring
- Prepare regulatory documentation (development reports, batch records, process descriptions)
- Lead process characterization and QbD studies, conduct risk assessments (FMEA)
- Drive root cause investigations, continuous improvement, and platform evolution
- Identify and evaluate novel purification technologies and PAT/digital tools
- Ensure development activities comply with cGMP and data integrity requirements
- Interface with Quality for inspection readiness and compliance
Key requirements- M.S. with 10+ years or Ph.D. with 7+ years in downstream process development
- Hands on LVV downstream process development experience preferred
- Expertise in clarification, chromatography, UF/DF (TFF), and sterile filtration
- Deep understanding of LVV impurity profiles (HCP, host cell DNA, process residuals) and mitigation strategies
- Experience supporting clinical and/or commercial scale processes and tech transfer
- Knowledge of cGMP, Quality Systems, and FDA/EMA guidance for gene and cell therapies; experience with regulatory filings (CMC)
- strong written and verbal communication
- ability to lead in matrixed environments
- stakeholder influence and collaboration
- LVV downstream purification
- clarification
- chromatography
