Experience

Greenphire

• United States
• IT Services and IT Consulting
• 200 - 300 Employee

• Team Manager, Project Management

  • Sep 2021 - Present

• Team Lead, Project Management

  • Nov 2020 - Sep 2021

• Sr. Project Manager III

  • Oct 2019 - Oct 2020



Cutanea Life Sciences, Inc.

• United States
• Pharmaceuticals
• 1 - 100 Employee

• Senior Manager of Product Development and Technical Operations

  • Feb 2018 - Jul 2019

  - Prepared and managed robust development fit for purpose plans for multiple products supporting the full development life cycle- Responsible for strategy integration with cross-functional teams and monitoring outcomes by determining key milestones, identifying and mitigating risks, noting deviations, corrective actions, and critical point decisions- Contributed to preparation of documentation and management of regulatory submissions to support NDA, IND, CBE-30, and IMPD- Led team to support technical transfer and launch of commercial product to national and international sites- Collaborated with and managed vendors on design and scale-up of processes, equipment, and manufacturing strategy from pre-formulation through commercial scale- Provided professional guidance to direct report for proof of concept through Phase III clinical supplies, junior team members, and international colleagues- Facilitated and managed proposals, timelines, schedules, agendas, and minutes- Responsible for financial management of contracts including negotiations, tracking invoices, and forecasting- Successfully managed technical transfer valued at $2M to ensure inventory of commercial supplies were maintained- Identified key risks for line extension activities to ensure equipment and transfer were complete to support validation. Risks included were international transportation parameters, compounding and packaging material qualifications, vendor audits, and site qualifications

• Manager of Product Development

  • Feb 2016 - Jan 2018

  Principle Accountabilities:- Employed project management best practices in directing new product scale-up, process optimization, technology transfer, and process validation activities- Provided scientific and technical input and led development issue resolution efforts- Identified and procured sources for the supply of and support qualification of active pharmaceutical ingredients and packaging components from vendors- Interfaced with internal clinical and quality colleagues and external vendors to coordinate non-clinical and clinical supplies to meet study timelines- Successfully managed the formulation development of several drug products and associated analytical and resource tasks to support manufacturing- Managed clinical supplies and labeling for US and EU studies from Phase I through Phase III



DPT Laboratories

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Project Coordinator

  • Jan 2015 - Feb 2016

  -Directed the execution of pharmaceutical projects through the development process, from early formulation development to agency filing and commercial launch production activities-Led cross functional teams in project team meetings and teleconferences. Develop and manage complex timelines detailing project parameters and financial milestones. Ensure adherence to SOPs, cGMP, and FDA requirements-Developed and managed complex timelines and schedules detailing key project parameters including financial milestones

• Project Management Coordinator

  • May 2012 - Jan 2015

  -Coordinated drug development and site transfer projects for a portfolio of national and international clients in all aspects, including technical, operational, and logistical execution from initial development through commercial launch-Communicated project information between internal and external team members and managed team performance -Maintained hard copy and electronic filing systems and created documents including spreadsheets, reports, agendas, and minutes

• Scientist

  • Jun 2009 - Apr 2012

  -Ensured accurate and timely testing and release of preliminary, finished, and stability studies, special test requests, method validation transfers, and investigations in order to support and meet project deadlines for multiple products in the quality control department in a dynamic cGMP environment-Worked with clients to test products, analyze data, and problem solve issues-Experience with laboratory techniques using HPLC, GC, Malvern Particle Size, Karl Fisher, titration, and atomic absorption spectroscopy