Senior Director-Biologics Analytical Development – Pivotal and Commercial

Senior Director-Biologics Analytical Development – Pivotal and Commercial

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 separation techniques (e.g. UHPLC, CE-SDS, iCIEF) commonly used for biologics analytical development.
• Subject matter expert in establishing comprehensive control strategies for biologics products.
• Expertise in the development/qualification of various assays, including for purity and process related impurities.
• 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 regulatory documentation at all stages, including IND, BLA, and PAS filings.
• Demonstrated ability of building strong collaborations with other CMC functions.
• Strong business acumen, with ability to balance resource, budget and program milestones.
• Working knowledge of lab automation, 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, strategic vision, executive presence. 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
• Accountable for: Analytical Methods: Development, Technical Support to QC, validations, and transfers, life-cycle management
• Developing analytical control strategies for drug substance and drug product, ensuring patient-centric considerations are incorporated
• High throughput analytical testing for drug substance and drug product development
• 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 standard, comparability, and specifications
• Drive for the 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.

Preferred Qualifications

No preferred qualifications provided.