Seeking experienced and creative individuals to lead late-phase synthetic molecule process development, including finalizing commercial route and process, characterizing the process, and defining the control strategy to support Phase 3 clinical supply, registration stability, regulatory submissions, process validation, and commercial hand-off.
Compensation
The anticipated wage for this position is $153,000 - $264,000
Responsibilities
Demonstrate a deep expertise and demonstrated capability in the utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges
Lead and/or supervise the finalization of commercial synthetic routes and the development of robust, scalable, and well-characterized API manufacturing processes, including starting materials selection and justification of the commercial route
Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives
Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; be able to apply these takeaways to a dynamic portfolio of small molecule programs
Possess solid understanding in unit operation design and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment
Steer global CMC strategy for cell and gene therapies, translating pioneering science into high-quality submissions and decisive health authority interactions to accelerate access for patients.
Locations (3)
Santa Monica, California, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
Compensation
The annual base salary for this position ranges from $186,232 - 279,349. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles).
Responsibilities
Shape end-to-end CMC regulatory pathways across development stages
Provide strategic guidance during all stages of product development
Lead product quality strategy and execution across development, manufacturing, analytical, and regulatory functions for small molecule products.
Compensation
The salary range for this position is: $191,250.00 - $247,500.00. 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.
Responsibilities
Provide quality leadership on cross-functional teams in a matrix environment
Execute product strategies through quality and scientific knowledge related to product development, technology transfers, global regulatory filing strategies, analytical methods, stability, drug substance and drug product specifications and In-Process Controls (IPCs)
Lead Product Quality Team activities to align product quality strategy, priorities, and deliverables across the product lifecycle
Drive identification, assessment, and mitigation of product quality risks using a science- and risk-based approach
Monitor and review cross-functional process and product data to identify trends and ensure quality and compliance risks are proactively addressed
Lead and manage product quality strategy across the product lifecycle, ensuring regulatory compliance and risk-based evaluation of process and product data.
Compensation
The salary range for this position is: $191,250.00 - $247,500.00. 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.
Responsibilities
Provide quality leadership on cross-functional teams in a matrix environment
Execute product strategies through quality and scientific knowledge
Lead Product Quality Team activities
Drive identification, assessment, and mitigation of product quality risks
Monitor and review cross-functional process and product data