Sr Director, Analytical Operations

Gilead Sciences•Foster City, CA

38d

About The Position

The Senior Director in Pivotal and Commercial Biologics Analytical Development, will be responsible for leading analytical development activities spanning structural characterization of protein-based modalities, establishing robust and comprehensive pivotal and commercial stage comparability strategies, establishing product-specific critical quality attributes (CQAs), and devising analytical testing strategies for characterization and control of glycosylation variants and excipient-related attributes. They will be responsible for a group of approximately 20 scientists by providing guidance, prioritization, and career development leadership. Through these activities they will play an instrumental role in ensuring the establishment of robust control strategies to support regulatory filing strategies.

Requirements

Ph.D. with 12+ years or M.S. with 15+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development with people leader accountabilities.
Extensive experience with analytical method development and control strategies of biologics products.
Well-versed in the application of mass spectrometry, biophysical techniques and separation methods commonly used for biologics structural characterization
Subject matter expert in establishing comprehensive control strategies for biologics products
Well-versed in high throughput assay methodologies, including automation
Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
Proven track record in drafting and defending regulatory documentation at all stages, including IND, BLA, and PAS filings.
Demonstrated ability to build strong collaborations with other CMC functions.
Strong business acumen, with ability to balance resource, budgets, and program milestones.
Working knowledge of computer validation, data governance, data science, knowledge management and data protection.
Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, and strategic vision.
Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.
Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Responsibilities

Provide leadership to a group of analytical development scientists
Mentor and guide scientists in their roles
Oversee budgeting for capital equipment
Set clear expectations and prioritization of work packages
Manage workload and resources effectively
Leading extended characterization studies, including those that employ mass spectrometry and other biophysical techniques
Define and implement phase-appropriate analytical comparability strategies for pivotal and post-approval manufacturing changes, including risk assessment, study design, assessment criteria, data interpretation, and regulatory justification
Building patient-centric considerations into overall control strategies – particularly as it pertains to identifying and assessing CQAs based on clinical relevance and product risk.
Establish and maintain a state-of-the-art analytical laboratory
Guide the authoring, review and approval of CMC sections in regulatory filings, and support interactions with health agencies
Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio
Exhibit comprehensive knowledge of cGMP practices and requirements
Act as a key member of the Analytical Development leadership team to shape late-stage development strategies
Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standards, comparability, and specifications
Drive adoption of novel and state-of-the-art analytical technologies and approaches
Set organizational goals that align with broader objectives while balancing immediate and long-term priorities
Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization