Lead Consultant

• Oct 2020 - Present

Consultant II - CMC

• Mar 2018 - Oct 2020

Director of Regulatory Affairs

• Jan 2016 - Mar 2018

Responsible for creating and managing CMC related regulatory filings to support St. Renatus’ drug product. Duties include developing regulatory strategy for post approval changes, drafting responses to FDA inquiries, assisting with development of Design History File for combination product, managing regulatory submissions, coordinating CMC activities for potential European MAA filing. Perform due diligence activities for portfolio valuation. Provide analytical and technical support for Manufacturing & QA including coordination of release testing for raw materials and finished products, analytical method transfers, and manufacturing process trouble shooting. Authoring, reviewing and approval of raw material and finished product specifications, authoring and reviewing change controls and non-conformances for internal processes as well as external CMO processes. Provide analytical support for OOS and other investigations.

Associate Director, Regulatory Affairs

• Apr 2012 - Jan 2016

Regulatory Project Manager coordinating submissions of pre-IND and pre-NDA meeting briefing packages, IND submissions, ANDA and NDA submissions, and post-submission communications management including annual reports and deficiency responses. Write and review Chemistry, Manufacturing and Controls (CMC) sections of submission packages. Perform CMC gap analysis on regulatory submissions. Provide technical assistance on analytical method development, validation programs and analytical trouble shooting. Assist clients with regulatory compliance issues such as preparing deficiency responses to regulatory agencies, and requests for designation for Fast Track Approval, document review and regulatory strategy. Assist clients with regulatory due diligence reviews.

Associate Director, Analytical Chemistry

• Jan 2010 - Apr 2012

Responsible for managing analytical development and support for renewable chemicals research and establishing Quality Systems for the Analytical Group. Responsibilities include: Managed identification of unknown byproducts as well as mass balance and product characterization projects within time and budget constraints. Managed analytical method technology transfer including round robin sample testing with CMO’s. Achieved less than 5% RSD difference between two completely independent laboratories. Directed qualification of novel analytical methods to support fermentation and recovery research for production of renewable chemicals to meet time constraints and analysis needs. Managed a group of six analysts and departmental budget, including purchase of instrumentation, design of a new laboratory and move into the new space, and negotiation of instrumental service contracts. Interacted with Research and Process Development groups to coordinate departmental goals and delivery of analytical support needs. Gave presentations to all company meetings regarding the Analytical Department projects demonstrating achievement of turnaround time and Quality targets.

Director of Bioanalytical Chemistry

• Sep 2008 - Jan 2010

Responsible for establishment and maintenance of Dicerna’s bioanalytical and analytical laboratory facilities and assays. Responsibilities included: Specified and purchased all equipment and instrumentation including two Acquity UPLC systems, and a triple quadrupole mass spectrometer, lab benches, centrifuges, analytical balances, and all other analytical equipment from start up. Stayed within budget and negotiated timely delivery of instruments and laboratory infrastructure. Developed assays for extracting therapeutic oligonucleotides from biological matrices including plasma and tissue for LCMS/MS analysis. Helped establish a new protocol for numbering and tracking research studies for use ultimately with an electronic laboratory notebook and laboratory database. Researched and specified a laboratory database and electronic laboratory notebook system to track oligonucleotide inventory, research results, and bioanalytical data. Hired and supervised a Ph.D.-level Senior Scientist. Established corporate Safety and Chemical Hygiene program a

Senior Scientist II

• Oct 2006 - Jun 2008

Responsible for all Analytical Development and Quality Control Chemistry duties to support IND enabling studies of novel antibiotic molecules. Responsibilities included: Supervised and managed two Research Associates. Sourced new analytical chromatography technology and optimized existing analytical methods to meet timing, budget and sensitivity constraints. Developed and qualified analytical methods for raw materials, intermediates and finished API. Reviewed external analytical data from Contract Research Organizations (CROs) to ensure compliance needs were met. Authored multiple analytical Qualification Reports and Standard Operating Procedures (SOPs) for non-Clinical compliance. Designed and managed Qualification Protocols for new analytical methods. Transferred protocols to external CROs for support of GLP non-clinical studies as well as GMP manufacturing, including CRO site visits and audits. Designed, executed and managed stability protocols for API. Designed and generated Certificates of Analysis; and technical reports for inclusion in an IND CMC section. Characterized and qualified new Analytical Reference Standards to support GMP, GLP and non-GLP studies. Expanded an existing analytical laboratory by sourcing and purchasing a Karl Fischer titrator for moisture analysis and FTIR spectrophotometer for material identification. Developed accompanying methods and Standard Operating Procedures.

Senior Development Scientist

• Apr 2004 - Sep 2006

Method development for LC-MS & MS/MS of therapeutic modified oligonucleotides including identity confirmation, impurity analysis & sequencing. Prepared data & authored reports for inclusion in CMC sections of 2 INDs including managing contacts with external CRO laboratories & evaluating technical reports. Performed LC-MS analysis & data evaluation to demonstrate equivalency of a proposed new manufacturing process for an API, including statistical data analysis. Designed experimental plan for comparison of new lyophilization protocol to existing protocol to improve heat transfer, also assisted with data evaluation & statistical analysis. Managed laboratory activities, including coordinating equipment transfers to a new laboratory site and continuing service contract coverage for analytical equipment under the new company. Designed and optimized synthesis and purification protocols for oligonucleotides (standard and modified) for use as raw materials in ASR and API components.

Oligosynthesis Manager

• 2003 - 2004

Managed implementation of GMP oligonucleotide production facility including authoring SOP, PV and MP documentation, method development and validation for synthesis and purification of oligonucleotides, interfacing with management and customers regarding technical capacity. Hired and managed a team of 4 personnel to validate and produce 114 cGMP compliant (ASR) oligonucleotides in less than a year. Manufacturing systems established were ultimately used to produce the genetic test Signature CF being marketed by Asuragen and Digene for Cystic Fibrosis testing.

Project Team Leader & Production Senior Scientist

• Oct 2000 - Jan 2003

Designed, developed and patented proprietary novel technology for dyeless DNA detection with applications toward microarrays (gene chips) and other high throughput biological analyses Researched new technologies and alpha tested novel nucleic acid chemistry reagents including: synthesis methods development and analysis of promising compoundsresearched novel synthesis supports which improved deprotection time by > 7 hours researched chemical modifier reagents that demonstrated improved coupling efficiency and robustness under synthesis conditionsInstalled, implemented and optimized the MerMade production system for LNA and DNA synthesis in Proligo’s High Throughput Oligonucleotide Production (HiTOP) laboratory Designed and specified Laboratory Automation System for the HiTOP expansion to increase throughput capacity

Research Fellow

• Jan 1998 - Oct 2000

Chemist

• 1990 - 1992

Chemist

• 1989 - 1990