Role Summary
The Senior Manager/Associate Director, MSAT/Process Characterization and Validation Readiness will lead AAV process characterization, technology transfer, control strategy development, and PPQ readiness activities across Sf9/baculovirus and HEK-based manufacturing platforms. This role will partner closely with internal CMC functions and CDMOs to ensure late-stage manufacturing processes are robust, well characterized, and ready for clinical and commercial execution.
Primary Responsibilities- Lead risk-based process characterization strategies and studies for AAV manufacturing processes using Sf9/baculovirus and HEK-based platforms
- Evaluate process robustness, critical process parameters, process performance, and product quality attributes to support control strategy development
- Translate development, engineering, and manufacturing data into technical conclusions that support validation readiness, PPQ planning, and regulatory documentation
- Partner with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and CDMO teams to align study design, execution, documentation, and deliverables
- Support technology transfer, manufacturing readiness, FMEA activities, comparability assessments, and process validation planning
- Author and review protocols, reports, technical summaries, regulatory sections, batch record inputs, and manufacturing support documents
- Lead technical troubleshooting and continuous improvement activities as appropriate
Required Skills & Qualifications- Advanced degree in biochemical engineering, bioprocess engineering, molecular biology, cell biology, biotechnology, or related discipline; Master's with a minimum of 7 years relevant experience or PhD with a minimum of 5 years relevant experience
- Experience in viral vector, gene therapy, biologics, or advanced therapy process development required; AAV experience strongly preferred
- Demonstrated experience with process characterization, process optimization, scale-up, scale-down models, technology transfer, and validation-readiness activities
- Working knowledge of upstream and/or downstream AAV manufacturing processes, including Sf9/baculovirus, HEK-based production, bioreactor operations, TFF, chromatography, or formulation preferred
- Understanding of DoE, Stage 1 Process Design, Stage 2 Process Qualification, PPQ, CPV, validation strategy, and BLA/PAI readiness preferred
- Strong understanding of process parameters, CQAs, control strategy development, risk assessments, and late-stage CMC decision-making
- Experience authoring and reviewing technical protocols, reports, regulatory documentation, and manufacturing support documents
- Demonstrated ability to lead cross-functional work, manage priorities, communicate clearly, and collaborate effectively with internal teams and CDMOs.
$176,000 - $187,000 a year
Compensation is dependent on qualifications and experience
Our work culture is a hybrid model with 2 days in the New York City office and 3 days working from home.
