Analytical LCM Product Lead - Biologics Job Lexington area,Massachusetts USA,Business

Job Description

About the role:

Biologics Portfolio LCM Analytical Oversight: Single point of accountability for all Analytical LCM Biologics programs. Direct people management of individual analytical LCM program leads to provide deep technical, quality, and regulatory insights that drive consistent and scientifically sound decisions.
Owns and drives Analytical LCM Portfolio Program Strategies for Biologics programs: Deep understanding of individual biologics product control strategies, working with individual biologics analytical LCM program leads to ensure all analytical LCM activities are covered and on track with clearly defined roles and responsibilities, schedules, and resources. Creates and maintains Analytical LCM program roadmaps and method risk registers in alignment with overall CMC program roadmaps, and provides direct line-functional leadership for all Analytical LCM program representatives - ensuring consistent scientific direction, portfolio prioritization, capability building, and clear accountability for program deliverables.
Analytical LCM Functional & Enterprise Leader: Works in strong collaboration and communication with the Analytical LCM Portfolio Leader, other Analytical LCM Modality Leads, MSAT Manufacturing Leads, Pharm Sci Analytical, QC sites, and internal and external analytical labs and services to align on ways of working, biologics analytical prioritization, network strategy, CMC biologics initiatives/roadmaps, and analytical lab work resourcing.
Tech Forward: Drives digital-forward analytical technology innovation and platform embedment in analytical methodology. Works in collaboration with key stakeholders from Pharm Sci to QC labs - including Quality, Regulatory, and IT - to pull the latest analytical methodology through into LCM control strategies.
Strategic and technical people leader for biologics portfolio analytical development technical and product strategies, roadmaps, and initiatives. Embeds AQbD and risk-based thinking in method development, qualification/validation, and lifecycle management to improve robustness, reduce investigations, and accelerate tech transfer and comparability.

How you will contribute:

Single point of accountability for the global Analytical LCM portfolio of Biologics, including monoclonal antibodies, bispecific/multispecific antibodies, fusion proteins, recombinant proteins/enzymes, and antibody-drug conjugates (ADCs).
Owner of the Analytical LCM Biologics Portfolio Strategy from late development through commercial. Maintains deep analytical engagement with, and understanding of, product control strategies. Works with individual Analytical LCM program leads to create and maintain overarching program plans that meet overall CMC program plans. Provides oversight of each program's Analytical LCM Roadmap and Method Risk Registers, driving communication and proactive planning to ensure appropriate analytical control strategies are in place for the lifetime of the commercial product.
Strong interface and communication with enterprise leaders across MSAT Analytical, MSAT Manufacturing, Pharm Sci, Quality, Regulatory, GSQ, QC sites, and IT to ensure program plans and needs are well integrated and resourced into existing and future control strategies.
Accountable for the integrated planning of ALL biologics program-specific analytical LCM activities to ensure continuity of control strategies - including methods, regulatory filings, justification of specifications, tech transfer, methods remediation planning, process changes, seamless supply, and bridging of control strategies for reference standards and key materials. Serves as analytical change control and comparability strategy owner and is ultimately accountable for biologics program-related analytical plans and execution of activities.
Coordination with Pharm Sci and Business Development to ensure incoming biologics program analytical strategies are consistently pulled through into commercial lifecycle management. Ensures analytical LCM plans and methods have appropriate quality management across the network, including standards, training, and inspection-readiness expectations for data integrity and documentation practices.
Oversight of biologics program method risk registers to monitor method performance and proactively implement measures to ensure products and methods remain in control for the lifetime of use.
Partner with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, Pharm Sci, and IT to ensure…