Experience

ImmunoGen, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Associate Director, Supply Chain

  • Apr 2022 - Present



Gilead Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director, External Manufacturing

  • Mar 2021 - Apr 2022



Immunomedics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director Supply Chain Management

  • Jul 2020 - Mar 2021

• Associate Director, Supply Chain Systems

  • Feb 2020 - Jun 2020

• Sr. Manager, Supply Chain

  • Jul 2019 - Feb 2020

• Manager, Supply Chain ERP

  • Sep 2018 - Jul 2019



Matinas BioPharma

• United States
• Biotechnology Research
• 1 - 100 Employee

• Manager, Cochleate LCNP Manufacturing

  • Aug 2017 - Sep 2018



Renaissance Lakewood, LLC

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Purchasing Specialist, API

  • Jun 2016 - Jul 2017

  -Purchased all API and inactive excipients for internal and third-party partners to support forecast requirements and development projects -Sourced and negotiated pricing with potential and approved suppliers for all API and excipient procurement activities -Reviewed technical and commercial information packets from vendors including DMFs, validation reports, and change notifications, serving as the central point of contact between Renaissance internal teams and… Show more -Purchased all API and inactive excipients for internal and third-party partners to support forecast requirements and development projects -Sourced and negotiated pricing with potential and approved suppliers for all API and excipient procurement activities -Reviewed technical and commercial information packets from vendors including DMFs, validation reports, and change notifications, serving as the central point of contact between Renaissance internal teams and suppliers -Served on the Continual Improvement team to develop and implement changes to the API/excipient introduction process, production scheduling, and internal material handling -Optimized Master Data and Reporting Activities within the Infor LN ERP System to generate accurate messages and for the Purchasing, Planning, Warehouse, and Commercial Service teams Show less -Purchased all API and inactive excipients for internal and third-party partners to support forecast requirements and development projects -Sourced and negotiated pricing with potential and approved suppliers for all API and excipient procurement activities -Reviewed technical and commercial information packets from vendors including DMFs, validation reports, and change notifications, serving as the central point of contact between Renaissance internal teams and… Show more -Purchased all API and inactive excipients for internal and third-party partners to support forecast requirements and development projects -Sourced and negotiated pricing with potential and approved suppliers for all API and excipient procurement activities -Reviewed technical and commercial information packets from vendors including DMFs, validation reports, and change notifications, serving as the central point of contact between Renaissance internal teams and suppliers -Served on the Continual Improvement team to develop and implement changes to the API/excipient introduction process, production scheduling, and internal material handling -Optimized Master Data and Reporting Activities within the Infor LN ERP System to generate accurate messages and for the Purchasing, Planning, Warehouse, and Commercial Service teams Show less



Tris Pharma

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Sr. Production Planner and Inventory Control Coordinator

  • Jan 2015 - Jun 2016

  -Translated commercial demand plan into a working production plan and schedule, considering labor, equipment, and time constraints -Compiled standard set-up, run, and clean times for all products for use in schedule optimization and cost of goods determination -Created master capacity plan to determine needed capital expenditures and hiring expansion and evaluate capacity for new business -Optimized production to increase output by 32% without expansion of labor or… Show more -Translated commercial demand plan into a working production plan and schedule, considering labor, equipment, and time constraints -Compiled standard set-up, run, and clean times for all products for use in schedule optimization and cost of goods determination -Created master capacity plan to determine needed capital expenditures and hiring expansion and evaluate capacity for new business -Optimized production to increase output by 32% without expansion of labor or equipment capacity -Led implementation of JD Edwards Oracle ERP System for Supply Chain functionality, translating Tris processes into the system and serving as one of five company-wide Master Users -Supervised team of inventory control personnel charged with issuing all raw materials and packaging components for commercial production, utilizing a FEFO consumption model and managing material retest periods, to maintain accurate counts -Drove bi-annual Physical Inventory and subsequent external financial audits to justify third-party loans and investment -Presented monthly production and inventory metrics to Tris Leadership Team, including company President/CEO -Trained Buyers and Warehouse personnel on writing investigations, preparing change controls, and creating department SOPs -Participated in launch marketing and production meetings for Dyanavel XR, Tris Pharma’s first in-house marketed product

• Technical Services Engineer II

  • May 2012 - Dec 2014

  -Prepared, executed, and completed process validation reports to meet the launch dates for one ER suspension, one ER powder, three solutions, and the first three tablet products produced commercially at Tris Pharma -Investigated batching and cleaning failures for validated and non-validated processes and implemented resulting CAPAs -Analyzed data generated from optimization batches to successfully scale-up multiple products -Collaborated with Pfizer new product team to… Show more -Prepared, executed, and completed process validation reports to meet the launch dates for one ER suspension, one ER powder, three solutions, and the first three tablet products produced commercially at Tris Pharma -Investigated batching and cleaning failures for validated and non-validated processes and implemented resulting CAPAs -Analyzed data generated from optimization batches to successfully scale-up multiple products -Collaborated with Pfizer new product team to complete product and equipment qualification needed to launch Quillivant XR -Revised framework of company’s SOPs for Process Validation, Establishment of Bulk Hold and Fill Times, and Creation of Master Batch Records based on recent FDA guidelines -Redesigned Master Production, Packaging, and Labeling Batch Records for process clarification for operators and reviewers -Devised system for Technical Services’ Studies Program, under which Removal Torque Determination Studies, Shipping Studies, and multiple Process Improvement Projects were completed -Supervised the initial qualification of multiple pieces of manufacturing equipment for the newly expanded facility, including main and ancillary processing tanks, granulation machines, fluid bed processors, a tablet compression system, and full packaging lines



G&W Laboratories

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Technical Services Engineer

  • Jun 2011 - May 2012

  -Developed and executed the process validation protocols and completed process validation reports to meet launch dates for two new cream products, one new ointment product, and one new gel product -Manufactured optimization batches to define process parameters and create batching recipes for the development of a cream process from a manual batching procedure to an automated batching procedure -Participated in the execution and design of Cleaning Validation… Show more -Developed and executed the process validation protocols and completed process validation reports to meet launch dates for two new cream products, one new ointment product, and one new gel product -Manufactured optimization batches to define process parameters and create batching recipes for the development of a cream process from a manual batching procedure to an automated batching procedure -Participated in the execution and design of Cleaning Validation procedures -Designed series of experiments to study the effects of major process parameters on solutions and suppository products -Provided validation-related information for Annual Product Reviews and Annual Product Reports -Updated Master Batch Records and Automated Process Recipes for process clarification

• QA Compliance Specialist

  • Jul 2010 - Jun 2011

  -Reviewed and provided initial approval of investigation reports from all company departments -Handled, investigated, and resolved customer complaints -Assisted in the development of CAPAs to correct problems identified throughout the investigation process -Conducted internal cGMP audits of Operations and Quality Control Departments to improve quality systems -Provided investigation-related information for Annual Product Reviews and Annual Product… Show more -Reviewed and provided initial approval of investigation reports from all company departments -Handled, investigated, and resolved customer complaints -Assisted in the development of CAPAs to correct problems identified throughout the investigation process -Conducted internal cGMP audits of Operations and Quality Control Departments to improve quality systems -Provided investigation-related information for Annual Product Reviews and Annual Product Reports -Performed second audit of executed batch records and associated documentation -Oversaw the closure of approximately 900 investigations, 70 complaints, 100 CAPAs, and 30 PDs over an 11-month period