AD, Analytical Science, Fremont CA

The Associate Director of Development Operations (Dev Ops), Analytical Science (AS), is a senior leader responsible for guiding, developing, and inspiring technical teams to deliver robust, reliable, and high quality analytical operations in support of clinical and commercial programs. The role provides strategic and operational leadership across Dev Ops and the Compliance Process Technologies (CPT) function, ensuring consistent execution of analytical methods and control strategies across the product lifecycle while aligning team priorities with long term CPT objectives and business needs.

A core responsibility of the Associate Director is to lead and sustain strong cross functional partnerships, particularly with Quality Control (QC), to ensure seamless analytical support to Production and Operations for both internal and contract manufacturing business (CMB) programs. The role provides scientific and operational leadership for NPI readiness, technology transfer, troubleshooting, investigations, deviations, and continuous improvement initiatives, and actively supports adoption of new analytical technologies and improved operating models.

Operating at the interface of Dev Ops Drug Substance, Process Transfer and Process Engineering, Cleaning Validation, QC, Production, Regulatory Affairs, and CMB partners, the Associate Director combines technical expertise and people leadership to enable predictable delivery, operational excellence, audit readiness, and sustained analytical performance.

This position offers a base salary typically between ($140,000) and ($222,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.

Strategy and Leadership:

• Aligns Analytical Science priorities and workflows with CPT strategy and site business goals, contributing to governance discussions and execution alignment.
• Leads, coaches, and develops analytical scientists and SMEs, fostering psychological safety, technical depth, and an adaptable team culture.
• Represents Analytical Science in CPT forums as appropriate, influencing decisions and driving aligned execution.

Technical Expertise & Support:

• Responsible for laboratory operations, ensuring safe, compliant, and efficient environments (safety, equipment readiness, 6S, data integrity).
• Delivers high-quality analytical method implementation, development, optimization, comparability, characterization, and robustness studies to support product and process understanding.
• Leads and supports analytical method and control-strategy lifecycle activities, including risk assessments, updates, continuous improvements, and stewardship.
• Maintains deep analytical method and product-quality knowledge across the product lifecycle to support inspections and sustained product performance.
• Contributes to CMC strategy and regulatory submissions, providing high-quality analytical data, scientific rationale, and technical justifications.

Innovation and Continuous Improvement:

• Identifies, evaluates, and supports the implementation of new analytical technologies and digital tools to enhance analytical capability, robustness, and operational effectiveness.
• Drives continuous improvement in analytical processes through workflow simplification, standardization, digitization, and cycle-time reduction.
• Engages with cross-site and network partners to benchmark performance, share best practices, and support harmonization of analytical approaches where appropriate.

Cross‑Functional & Network

Collaboration:

• Provides clear analytical and operational direction across cross‑functional partners, aligning expectations and enabling consistent execution.
• Leads and sustains strong partnerships with QC and key operational functions.
• Provides scientific and operational leadership for deviations, CAPAs, investigations, and regulatory submissions, including cross‑functional troubleshooting across DS and DP.
• Leads analytical support for the Contract Manufacturing Business (CMB), including client…