I lead RA CMC strategy for Alnylam's first GalNAc conjugate candidate, including development and execution of the NDA, MAA and rest of world submissions. I manage a group of RA CMC staff, who support both early and late phase programs. My responsibilities also include capability building for the RA CMC group, including developing a Project Management function and leading process development projects.

I lead CMC regulatory activities for Seres’ novel class of microbiome products, including both human-sourced as well as synthetically manufactured drug products. This is a unique and highly impactful position that combines traditional CMC biotechnology regulatory activity with innovative strategic elements necessary to support the development of first in class microbiome products, which have minimal regulatory precedent. While in this role, I intend to not only define the CMC strategy in… Show more I lead CMC regulatory activities for Seres’ novel class of microbiome products, including both human-sourced as well as synthetically manufactured drug products. This is a unique and highly impactful position that combines traditional CMC biotechnology regulatory activity with innovative strategic elements necessary to support the development of first in class microbiome products, which have minimal regulatory precedent. While in this role, I intend to not only define the CMC strategy in support of Seres clinical programs, but also begin to lay the foundation for microbiome product industry-wide regulation. Show less

Technical writing is part of the CMC program management group and interfaces between the technical functions and Reg-CMC to ensure creation of high quality Technical Reports/Source Documents and regulatory CTD Documents for major submissions (BLA, sBLA, PAS, IND MAA, IMPD) across 5+ large molecule programs, with the goal of creating well written documents which meet applicable regulatory standards and are globally approvable by regulatory agencies. Daily tasks include: Providing… Show more Technical writing is part of the CMC program management group and interfaces between the technical functions and Reg-CMC to ensure creation of high quality Technical Reports/Source Documents and regulatory CTD Documents for major submissions (BLA, sBLA, PAS, IND MAA, IMPD) across 5+ large molecule programs, with the goal of creating well written documents which meet applicable regulatory standards and are globally approvable by regulatory agencies. Daily tasks include: Providing guidance and support to the technical functions on regulatory expectations and regulatory key messaging. Working with technical functions to ensure Technical Reports adequately support the regulatory submissions. Compilation and escalation of submission gaps/risks/mitigations. Driving functional alignment on key strategy and messaging. Coordination of functional reviews of the regulatory document content. Providing documents approved by the CMC organization and the technical functions to the Regulatory group. Show less

Global Regulatory CMC lead for a next-generation biologic nearing commercialization. Responsible for planning, strategy and management of all CMC regulatory submissions related to the product. Serve as a key member of the CMC Product Team (along with MFG, QA, Project Mgmt, Development, etc.). Responsible for communicating global regulatory CMC requirements to the Product Team, to ensure submissions are suitable for both US and ROW. Ensure Product Team decisions are communicated to other Reg… Show more Global Regulatory CMC lead for a next-generation biologic nearing commercialization. Responsible for planning, strategy and management of all CMC regulatory submissions related to the product. Serve as a key member of the CMC Product Team (along with MFG, QA, Project Mgmt, Development, etc.). Responsible for communicating global regulatory CMC requirements to the Product Team, to ensure submissions are suitable for both US and ROW. Ensure Product Team decisions are communicated to other Reg groups (International, Development, Labeling, etc.) as needed. Support commercial lifecycle management submissions, clinical trial applications, and new marketing authorizations for other biologic and small molecule products. Show less

Responsible for evaluating plant activities at a large biologics manufacturing facility in order to determine regulatory impact and coordinate and write necessary regulatory filings. Works with MFG and QA to implement changes only after appropriate regulatory updates have been filed. Interacts with international regulatory bodies during plant inspections.

Monitors/supports quality performance of facility by ensuring compliance w/ applicable reg requirements/standards. Provides guidance & facilitates training on regs. Stays current on reg issues in order to be effective auditor/compliance consultant to Site. Exercises judgment w/in broad regulatory realm in order to select/evaluate CAPAs for Site. Applies reg knowledge in complex problem resolution. Responsible for all facility related audit activities (internal audits, partner/corporate audits,… Show more Monitors/supports quality performance of facility by ensuring compliance w/ applicable reg requirements/standards. Provides guidance & facilitates training on regs. Stays current on reg issues in order to be effective auditor/compliance consultant to Site. Exercises judgment w/in broad regulatory realm in order to select/evaluate CAPAs for Site. Applies reg knowledge in complex problem resolution. Responsible for all facility related audit activities (internal audits, partner/corporate audits, CMO/supplier audits). Primary compliance contact for upcoming CTD/PAI: PAI readiness, facility prep, training, data integrity review of reports supporting CMC section of CTD. Conducts improvement activities and increases awareness of Quality expectations by reporting Quality Metrics, development/enhancement of Q Systems, complaint monitoring, supports process/product improvement initiatives, acts as Facility rep on co. wide QSys initiatives, etc. Show less