Define and execute purification development strategy for a portfolio of pivotal, commercial, and lifecycle-management biologics programs, providing scientific and technical direction for process development, characterization, scale-up, validation readiness, technology transfer, and commercial manufacturing support.
The salary range for this position is: $226,185.00 - $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
- Define and execute purification development strategy for a portfolio of pivotal, commercial, and lifecycle-management biologics programs.
- Provide scientific and technical direction for process development, characterization, scale-up, validation readiness, technology transfer, and commercial manufacturing support.
- Oversee development of robust and manufacturable drug substance purification processes, including harvest clarification, chromatography, virus inactivation, virus filtration, ultrafiltration/diafiltration, formulation, and final drug substance filtration.
- Direct risk-based process characterization strategies, scale-down model development, process parameter evaluation, and establishment of scientifically justified process control strategies.
- Provide technical support for technology transfers to internal manufacturing sites, external partners, and contract development and manufacturing organizations.
Compliance Specialist IIIThermo Fisher Scientific · Plainville, US