Gilead
Pharmaceutical
ExecDirector,AnalyticalOperations
“Exec Director, Analytical Operations at Gilead. Skills: Analytical Operations, CMC Development, AI/ML, Process Analytical Technology. Lead and manage a team. creating and executing analytical technology roadmaps”
What You'll Achieve.
creating and executing analytical technology roadmaps to support advanced manufacturing initiatives; harmonize end-to-end analytical control strategies; enhance productivity; ensure successful integration in all Gilead therapeutic modalities; secure global health authority approval for innovative analytical methods; actively contribute to the development of future global regulatory standards
Industry & Context.
Develop approaches and tools that connect product quality and stability with variations in raw materials, process conditions, and data from product characterization; Balance adopting new technology with maintaining data utility
What They're Looking For.
Must Have
Ph. D. Degree in Analytical Chemistry, Pharmaceutical Science, Chemical Engineering, or equivalent, 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, Proven record of enabling and implementing new technologies, Extensive experience influencing effectively within a matrix organization, Demonstrated expertise in data sciences, Demonstrated expertise in process analytical technology (PAT), Demonstrated expertise in chemometrics, Demonstrated expertise in automation, Proficient in AI/ML applications within the pharmaceutical sector, Balance adopting new technology with maintaining data utility, Proven ability to lead organizational change initiatives successfully, Substantial experience preparing regulatory submissions, Substantial experience engaging with regulatory authorities, interpersonal skills, communication skills, collaboration skills, Commitment to building teams across cultures, technical skills, and organizational levels
Nice to Have
AI/ML applications, Process Analytical Technologies (PAT), miniaturization, rapid microbiological testing, advanced technologies for implementation in GMP routine quality control testing, external innovation network, emerging analytical technologies, FDA’s Emerging Technology Team (ETT)
What You'll Do.
Lead and manage a team
creating and executing analytical technology roadmaps
support advanced manufacturing initiatives
Leverage existing and novel analytical technologies
harmonize end-to-end analytical control strategies
Develop approaches and tools
connect product quality and stability
Collaborate with stakeholders
evaluate how new analytical technologies affect pipeline progress
Oversee analytical lab automation
high-throughput analysis
evaluate advanced technologies
Deliver strategic leadership
establishing an external innovation network
facilitating collaborations
Evaluate the feasibility of emerging analytical technologies
guide their development
ensure successful integration
Collaborate with internal teams
secure global health authority approval
Influence senior leadership and stakeholders
communicating analytical advances
representing the company at scientific forums
contribute to the development of future global regulatory standards
How You'll Work.
Team & Collaboration
close partnership with Technical Development, Quality, Regulatory, and Manufacturing teams; Collaborate with stakeholders; internal teams such as Technical Development, Regulatory, Quality, and Manufacturing; external partners like peer biopharma companies and vendors; interpersonal, communication, and collaboration skills; Commitment to building teams across cultures, technical skills, and organizational levels
Communication Scope
interpersonal, communication, and collaboration skills; communicating analytical advances
Process & Methodology
lead organizational change initiatives
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