Job Description
The Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics), and Cross-Modality Compounds (e.g., Antibody-Drug Conjugates).
A fantastic opportunity has arisen for an External Large Molecule Analytical Testing Group Lead. The successful candidate will be responsible for the organization and direction of a newly created team within the GQ-LMAS organization.
This is an opportunity to build and oversee a high performing team focused external analytical sciences that enables our company’s strategic priorities to deliver life-changing products through robust launch of pipeline products and uninterrupted supply of commercial product. This role involves not only direct people management but also developing external network partnerships and implementing proactive and standardized analytical engagement with external focus factories and external providers. Additionally, this position will involve strong collaboration across multiple internal functions including but not limited to analytical program leaders and analytical method experts, AR&D, procurement, process and external manufacturing leads, quality and regulatory.
Responsibilities include but are not limited to:
People management for the External Large Molecule Analytical Sciences Group
Build and sustain high performing team focused on external analytical technical activities.
Core membership in joint steering teams with external providers
Engage with external providers and AR&D to build strong relationships that identify, manage, and as needed escalate risks and challenges in a proactive and collaborative manner.
Participate in analytical testing lab siting efforts (e.g., due diligence) with a strategic analytical siting mindset.
Review and approve technical documentation including support of complex deviations and laboratory investigations as needed.
Drive continuous improvement initiatives to enhance the analytical capability and robustness of external testing through implementation of strategic analytical efforts, best practices and assay monitoring.
Build and manage project plans, timelines, and schedules to effectively meet project timelines and deliverables.
Collaborate with departmental and cross-functional commercial manufacturing teams to support analytical technical components of facility sustainability activities.
Support technical readiness to ensure our manufacturing sites are prepared for inspections from multiple agencies (i.e., FDA, EMA, PMDA)
Minimum Education Required and Experience:
Bachelor’s Degree (BA/BS) with a concentration in biology, chemistry, biochemistry, or related science with ten (10) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
Master’s Degree (MA/MS) with a concentration in biology, chemistry, biochemistry, or related science with eight (8) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
PhD with a concentration in biology, chemistry, biochemistry, or related science with five (5) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation.
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