Experienced professional with 15 years working in CMC, Regulatory and QA. In-depth knowledge related to biologics development, life-cycle management, and drug substance and drug product manufacturing. Demonstrated successes in both a strategic capacity, as well as executing on day to day tasks. I am seeking a leadership role where I can make impactful and innovative improvements by leveraging my strong work ethic and extensive Regulatory, CMC, Quality, and Compliance experience.

CMC - Technical Writer @ 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. From September 2012 to November 2015 (3 years 3 months) Manager, RA-CMC Biologics @ 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. From March 2011 to October 2012 (1 year 8 months) Senior Regulatory Associate - CMC @ 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. From July 2008 to March 2011 (2 years 9 months) Senior Compliance Specialist @ 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. From January 2008 to June 2008 (6 months) Compliance Specialist @ From May 2006 to January 2008 (1 year 9 months) Associate III, QA - Product Complaints @ From July 2001 to May 2006 (4 years 11 months)

Master's Degree, Bioscience Administration @ Worcester Polytechnic Institute From 2015 to 2018 M.S, Regulatory Affairs @ Northeastern University From 2005 to 2008 Bachelor of Science (B.S.), Biology, General @ Dickinson College From 1995 to 1999 Melissa Marschel is skilled in: Regulatory Affairs, Quality Assurance, Auditing, FDA, CAPA, Compliance, Regulatory Submissions, Regulatory Requirements, Regulatory Strategy, Regulatory Risk, Regulatory Inspections, Product Complaints, Quality Systems, CMC, Biologics