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

Job Description

Synthetic Molecules (SM) Portfolio LCM Analytical Oversight: Single point of accountability for all Analytical LCM Synthetic Molecule Programs. Direct people management of individual analytical LCM program leads to provide deep technical, quality, and regulatory insights to drive consistent and scientifically-sound decisions.
Owns and drives Analytical LCM Portfolio Program Strategies for Synthetic Molecule (SM) Programs: Deep understanding of individual synthetic molecule product control strategies and works with individual SM analytical LCM program leads to ensure all analytical LCM program activities are covered and on track with clearly defined roles and responsibilities, schedules and resources. Works to create and maintain Analytical Program LCM roadmaps and method risk registers in alignment with overall CMC program roadmaps.

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 working 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, synthetic molecules analytical prioritization, network strategy, CMC synthetic molecule initiatives/roadmaps, and analytical lab work resourcing.
Tech Forward: Driving towards digital-forward, analytical technology innovation and platforming embedment in analytical methodology. Working in collaboration with key stakeholders from Pharm Sci to QC labs, including quality and regulatory and IT to pull-through the latest analytical methodology into LCM control strategies.
Strategic and technical people leader for small molecule portfolio analytical development technical and product strategies, roadmaps & initiatives. Embed 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 Synthetic Molecules including traditional synthetic molecules, peptides, oligonucleotides, and linker payloads for ADCs.
Owners of Analytical LCM Synthetic Molecules Portfolio Strategy from late dev - commercial. Deep analytical engagement and understanding of product control strategies. Works with individual Analytical LCM program leads to create and maintain overarching program plans to meet overarching CMC program plans. Oversight of each program Analytical LCM Roadmap and Methods Risk Registers and driving communication and proactive planning ensuring appropriate analytical control strategies are in place for the lifetime of the commercial product.
Strong interface & communication with enterprise leaders in 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 for ALL analytical synthetic molecule program-specific LCM activities to ensure continuity of control strategies including methods, regulatory filings, justification of specs, tech transfer, methods remediation planning, process changes, seamless supply and bridging of control strategies for reference standards & key materials for a program, analytical change control and comparability strategy owners. Ultimately accountable for analytical synthetic molecule program-related plans and execution of activities.
Coordination with Pharm Sci & BD on integration of incoming synthetic molecule 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 on synthetic molecule 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…