Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Associate Manager

  • Sep 2022 - Present

  Rensselaer, New York, United States Prepares global CMC documents and sections for a variety of clinical regulatory submissions, manages and coordinates the authoring, reviewing, and finalization of CMC documents and responses to CMC-related inquires from agencies, reviews relevant CMC documents and reports for completeness and accuracy, and reviews regulatory submission documents to ensure submissions are complete, accurate, and meet relevant requirements.

• CMC Regulatory Sciences Specialist

  • Jan 2020 - Sep 2022

  Rensselaer, New York Prepares global CMC documents and sections for a variety of clinical and commercial regulatory submissions, manages and coordinates the authoring, reviewing, and finalization of CMC documents and responses to CMC-related inquires from agencies, reviews relevant CMC documents and reports for completeness and accuracy, and reviews regulatory submission documents to ensure submissions are complete, accurate, and meet relevant requirements.

• Associate CMC Regulatory Sciences Specialist

  • Nov 2016 - Jan 2020

  Assists with maintaining and completing amendments for regulatory filings in US and ROW countries. Collaborates and develops relationships with functional area and cross functional teams, contract manufacturing organizations, and global Regulatory partners.



Banana Republic

• United States
• Retail
• 700 & Above Employee

• Brand Ambassador

  • Feb 2016 - Nov 2016

  Langhorne, PA Communicate and assist customers in order to find correct merchandise, restock merchandise, place merchandise, use registers to - complete transactions, find prices, find merchandise, and complete returns, and participate in shipment by - opening boxes and items, placing merchandise and cleaning up the debris. Previously worked for Old Navy for 5 years prior to starting at Banana Republic Recently promoted to Key Holder which allows for me to be acting manager during non-open store hours… Show more Communicate and assist customers in order to find correct merchandise, restock merchandise, place merchandise, use registers to - complete transactions, find prices, find merchandise, and complete returns, and participate in shipment by - opening boxes and items, placing merchandise and cleaning up the debris. Previously worked for Old Navy for 5 years prior to starting at Banana Republic Recently promoted to Key Holder which allows for me to be acting manager during non-open store hours to complete tasks. Can open, close and count registers. Can perform overrides on registers for discounts. Show less



Train Smart

• Product Assistant

  • May 2015 - Aug 2015

  Rochester, NY Worked at a start company based out of the University of Rochester. The company was working to commercialize their mobile app medical device that would be used to help toilet train children with autism. Tasked with researching and helping to develop the FDA regulatory strategy the startup company would used. By researching and using communications with DICE, I was able to determine the device would be considered a Class II exempt.



University of Rochester

• United States
• Higher Education
• 700 & Above Employee

• Medical Technology Innovation Master's Student

  • Jul 2014 - Aug 2015

  Rochester, New York Area Participated in an 8 week Clinical Practicum with a partner in the area of Orthopaedic Spine where direct observations in the OR and communication with Physicians, Nurses, and other hospital personnel lead to the identification of a list of 60+ clinical needs. This list of needs was refined to select one need to develop by conducting Voice of the Customer Interviews, and research on the technical and IP landscape. The need to develop a Bone Graft Delivery Device for Minimally Invasive… Show more Participated in an 8 week Clinical Practicum with a partner in the area of Orthopaedic Spine where direct observations in the OR and communication with Physicians, Nurses, and other hospital personnel lead to the identification of a list of 60+ clinical needs. This list of needs was refined to select one need to develop by conducting Voice of the Customer Interviews, and research on the technical and IP landscape. The need to develop a Bone Graft Delivery Device for Minimally Invasive Transforaminal Interbody Lumbar Fusion Surgery was selected. Then a list of wants, needs, and specifications were developed for this need based off of Voice of the Customer Interviews. This information was then used to perform brainstorming and iterative prototyping until an end stage Proof of Concept Prototype was developed and tested in preliminary bench testing. Throughout the develop, surgeons were kept engaged and continually met with to discuss design changes. Additionally, the FDA Regulatory Strategy was researched as to what class this device would fall into (Class 2) and what steps would be need to be completed to have the 510K approved. Research was also conducted for manufacturing of the device to allow for the device to be designed for manufacturability. Additionally, a full business plan and model was developed for the product based off of the concept of having both reusable and disposable components. There was also a focus in developing knowledge and understanding of the Intellectual Property Process. A provisional patent was filed and accepted based on the design of this device.

• Senior Design Teaching Assistant

  • Sep 2014 - May 2015

  Rochester, New York Area Worked as a facilitator and direct liaison between students and professors with two Senior Design groups, one whose project was on Knee Adduction and one whose project was on Endplate Preparation for Spinal Fusion Procedures. Attended weekly design meetings to discuss project milestones and progress. Assisted groups with design and specification troubleshooting. Participated in grading both written and presentation assignments for multiple groups throughout the two semesters.



RPI Athletics

• Work Study

  • Oct 2010 - May 2014

  Troy, NY Acted as a receptionist by directing and answering questions to individuals whom entered the office, filed and copied paperwork, compiled mailings and answered phones when necessary.



Old Navy

• United States
• Retail
• 700 & Above Employee

• Sales Associate

  • Nov 2008 - May 2014

  Fairless Hills, PA Communicated and assisted customers, restocked merchandise, placed merchandise, built visuals and displays, used registers to compete transactions and returns, folded and replaced clothing customers decided against purchasing in fitting rooms and at register



Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Quality Assurance Validation Intern

  • May 2013 - Aug 2013

  Rensselaer, NY Designed a statistic tool in collaboration with superiors and statisticians to determine whether Cleaning Validation Data was in or out of trend based on previous data that was recorded and organized in Microsoft Excel by using control charts in Minitab. Presented completed project to Senior Leadership Team at Regeneron Pharmaceuticals



RPI Physics Department

• Physics 2 Classroom Facilitator

  • Jan 2012 - May 2012

  Troy, NY Assisted with classroom activities and answered questions, and graded papers and exams