Exec Director, Analytical Operations

Descripción del trabajo

Responsibilities

• Lead and manage a team responsible for creating and executing analytical technology roadmaps to support advanced manufacturing initiatives including continuous manufacturing and real-time release testing. This encompasses the development of online and inline analytical technologies, innovative Process Analytical Technologies (PAT), increased automation, miniaturization, applications of artificial intelligence and machine learning (AI/ML), as well as rapid microbiological testing.

• Leverage existing and novel analytical technologies to harmonize end-to-end analytical control strategies of all Gilead therapeutic modalities in close partnership with Technical Development, Quality, Regulatory, and Manufacturing teams.

• Develop approaches and tools that connect product quality and stability with variations in raw materials, process conditions, and data from product characterization.

• Collaborate with stakeholders to evaluate how new analytical technologies affect pipeline progress, comparability strategies, and investigations.

• Oversee analytical lab automation, high-throughput analysis, and AI/ML initiatives to enhance productivity, and evaluate advanced technologies for implementation in GMP routine quality control testing.

• Deliver strategic leadership in establishing an external innovation network by facilitating collaborations with leading academic institutions and industry vendors. Evaluate the feasibility of emerging analytical technologies and guide their development to ensure successful integration in all Gilead therapeutic modalities

• Collaborate with internal teams such as Technical Development, Regulatory, Quality, and Manufacturing, as well as external partners like peer biopharma companies and vendors, to secure global health authority approval for innovative analytical methods. This includes working closely with CMC Regulatory Affairs to proactively develop strategies for engaging regulatory agencies regarding new analytical technologies, such as through FDA’s Emerging Technology Team (ETT), etc.

• Influence senior leadership and stakeholders by communicating analytical advances and representing the company at scientific forums, regulatory meetings and industry consortia to actively contribute to the development of future global regulatory standards.

Qualifications

• Ph.D. Degree in Analytical Chemistry, Pharmaceutical Science, Chemical Engineering, or equivalent with 14+ years of experience in CMC development of small molecule and/or biologic products.

• Externally recognized as an industry expert and thought leader in a related analytical discipline with proven record of enabling and implementing new technologies.

• Extensive experience influencing effectively within a matrix organization.

• Demonstrated expertise in data sciences, process analytical technology (PAT), chemometrics, and automation.

• Proficient in AI/ML applications within the pharmaceutical sector.

• Balance adopting new technology with maintaining data utility.

• Influence senior leadership and stakeholders by communicating analytical advances and representing the company at scientific forums, regulatory meetings and industry consortia to actively contribute to the development of future global regulatory standards.

• Proven ability to lead organizational change initiatives successfully.

• Substantial experience preparing regulatory submissions and engaging with regulatory authorities.

• Strong interpersonal, communication, and collaboration skills with proven ability to influence senior leaders and stakeholders.

• Commitment to building teams across cultures, technical skills, and organizational levels.