AD, Analytical Science, Fremont CA ONSITE

BoehringerPRD•Fremont, CA

20d•Onsite

About The Position

The Associate Director of Development Operations (DevOps), 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 DevOps 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 DevOps 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.

Requirements

PhD with six plus (6+) years of experience or Masters with eleven plus (11+) years and/or Bachelor’s with thirteen plus (13+) years of experience in the biopharmaceutical industry with direct experience in analytical science.
4+ years of experience leading people or teams, with demonstrated ability to coach, develop, and motivate scientists and technical professionals in a matrixed environment.
Experience in late‑stage analytical activities preferred, including PPQ support, comparability assessments, stability programs, and regulatory submissions.
Strong technical expertise in biologics analytical chemistry and/or biological assays, including CMC development, comparability assessments, and exposure to late‑stage development and commercialization support.
Thorough understanding of analytical method development, qualification/validation, technology transfer, lifecycle management, and troubleshooting across the product lifecycle.
Solid understanding of Quality Control operations, regulatory expectations, and regulatory submission requirements related to analytical methods and data.
Working knowledge of QC and QA principles in a GMP environment, with demonstrated ability to apply these principles to ensure compliant execution and inspection readiness.
Proficiency in statistical analysis and design of experiments (DOE), with the ability to apply data‑driven approaches to method development, optimization, and problem solving.
Demonstrated ability to build and sustain productive relationships with cross‑functional and organizational partners to enable aligned execution and delivery.
Proven track record in leading and developing high‑performing teams, translating direction and priorities into clear, actionable goals and measurable results, supported by strong business acumen.
Demonstrates self‑directed leadership, with the ability to mentor, coach, and develop direct reports and effectively lead teams within a matrixed organizational structure.
Exercises independent judgment and decision‑making, with the ability to think conceptually, understand the impact of decisions on product quality and business outcomes, and manage priorities in alignment with key drivers and stakeholders.
Ability to create, contribute to, and lead high‑performing teams, collaborating effectively with colleagues at all levels and establishing strong working relationships across diverse perspectives and personalities.
Applies flexible, risk‑based problem‑solving, providing well‑reasoned options and recommendations to support management review and informed decision‑making.
Demonstrates initiative and influence, proactively taking on additional responsibilities, responding to emerging situations, and providing guidance and leadership during periods of change or ambiguity.
Strong communication skills (written and verbal), with the ability to clearly convey complex technical and operational topics, negotiate effectively, and present professionally to internal and external stakeholders.
Experience leading or supporting organizational transformation, including adoption of new operating models, processes, or technologies.
Demonstrated business acumen, including a solid understanding of budgeting processes, financial tools, and resource stewardship within an operational environment.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

Nice To Haves

Experience in late‑stage analytical activities preferred, including PPQ support, comparability assessments, stability programs, and regulatory submissions.

Responsibilities

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.
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.
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.
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 engagement, proposal input, and delivery of analytical commitments.
Drives cross‑site collaboration within the DevOps network to align analytical approaches, advance technologies, and promote harmonized best practices.
Ensures compliant execution of analytical activities in alignment with CPT, ALCOA+ principles, data integrity, and site governance requirements.
Maintains audit and inspection readiness for Analytical Science, ensuring high‑quality analytical contributions and timely closure of actions.
Supports inspections and audits as an analytical SME, including preparation of documentation, responses, and technical justifications.
Builds and sustains analytical capabilities required to support evolving site and portfolio needs, including technical depth and leadership capacity.
Ensures teams are appropriately staffed, trained, and deployed to meet business priorities.
Supports succession planning, career development, and capability growth for direct reports and key roles.
Leads teams through organizational change, fostering psychological safety and adoption of improved operating models.