Maria Debruin Email & Phone Number

Effectively led the method development, routine testing and QC teams to facilitate early phase drug substance process development and drug product formulation development, resulting in an IND filing. Empowered teams to develop target-specific analytical methods using forced degraded materials to evaluate product stability, and author validation protocols, execute validations and finalize results in validation summary reports. Skillfully managed all aspects of: issuing CoTs/CoAs, reference standard programs, stability programs, setting shelf-life using statistical analysis, setting and justifying specifications, investigating OOS/lab deviations, outsourcing activities including method transfers, negotiating/approving quotes/contracts. Partnered with R&D, manufacturing, and business development to solve complex challenges and identify solutions to be GMP ready after a facility move. Expertly presented to and collaborated with C-suite leadership, providing critical insights and recommendations to support and guide company decisions. Successfully strategized and executed the company's vaccine, GMP analytical platform regulatory strategy, led key decision making in support of regulatory filings and authored IND, CMC sections.

Led and managed the analytical technology transfer of the Covid-19 program to Samsung Biologics, and collaborated with cross-disciplinary teams to execute the successful completion of two 50L IVT scale batches to produce millions of doses of the mRNA Covid-19 vaccine. Developed and authored a comparability plan and final summary report to demonstrate transfer success. Collaborated with key stakeholders to develop a phase appropriate, analytical control strategy, including the identification of the quality target product profile (QTPP) and critical quality attributes (CQAs), justification of specifications and establishment of test methods to enable product QC batch release, and supported development of extended characterization, formulation development, comparability assessments and stability programs. Managed all aspects of raw material control by working with external partners to develop and validate test methods, and set specifications for release.

Led and mentored a team of scientists to develop drug product formulations, with a focus on oral dosage forms, by collaborating with cross-functional project team members. Managed all project-related analytical activities, including method development, validation, transfer, drug product and excipient specification setting, and release of raw materials (excipients), API and drug product. Provided oversight of all external activities with contracting groups to ensure all protocols, validations, implementation, testing and release of clinical material met critical timelines to support all phases of drug development. Expertise in chromatographic and non-chromatographic method development with a special focus on dissolution techniques. Worked on cross-disciplinary teams to support product development by writing memos/technical documents, reporting data through effective presentations to regulatory authorities and leading research to resolve product issues. Using a strong understanding of the VICH, ICH, EMA and FDA guidelines, and USP and Ph. Eur compendia, independently authored all analytical CMC submission documents, and the QBR, for filing purposes.

MONMOUTH UNIVERSITY Inorganic chemistry professor for college level science majors. Independently created new rubrics, inquiry-based labs and scientific writing activities for the department to improve student achievement. Mentored and instructed college students for career readiness by providing guidance related to job roles in the field of science and education. Created and implemented a “High School Discovery Day” to actively engage high school students in university laboratory work while simultaneously creating recruitment opportunities for high performing Advanced Placement science students.BRICK BOARD OF EDUCATIONReceived the prestigious National Milken Educator Award in 2017-2018, $25,000 prize for educational leadership, program development, equitable access to education and high student test scores. Received the Brick Memorial Teacher of the Year Award in 2016-2017. Active team-player as a state planning board member for the NJ Department of Education Equity Conference. Selected for the State-wide conference to present: Equity in the AP Classroom, which highlighted key strategies to create equitable opportunities for all students. Honored by Brick Township with “Maria DeBruin Day”, December 8th, for excellence in teaching and for outstanding, free science education programs in the community. Created a YouTube channel for students to learn AP Chemistry through recorded teacher lectures. State recognized community outreach program ‘SCIENCE NIGHT OUT’: seven years running. Through effective leadership, independently developed, led and hosted a free, high energy, theatrical, community-wide science show, with over one thousand attendees yearly. Built strong corporate relationships to obtain multiple donations/grants from NJ Teacher’s Insurance, Home Depot, Walmart and Jersey Mike’s to pay for the show’s expenses. Featured on PBS TV three times showcasing successful teaching strategies.

Collaborated with MCAAD senior management and elite, Milken educator fellows to assist in the development of a toolkit of resources, including guidance and teaching materials that will help educators and parents engage with learners around the MCAAD themes (prosperity, financial literacy, access to capital and an entrepreneurial spirit).

Serving as a member of the Research Educational Laboratories governing board to evaluate, recommend and disseminate educational research. Collaboratively working with state education leaders/commissioners and policy makers, under the direction of Mathematica in Washington D.C.

Responsible for the creation, implementation and management of the chemistry e-learning program. Experience in instructional design and delivery of e-learning modules through the production of video tutorials. Liaison between the US team and India team of reviewers to ensure new and engaging technology resources are used to facilitate effective virtual learning.

Rahway, Nj

Conducted research in a fast-paced, multidisciplinary team environment to develop active pharmaceutical ingredients (API) using advanced analytical techniques. Participated in analytical filing applications for the FDA and complied with all Good Manufacturing Practices, standard operating procedures. s (SOPs). Successfully developed methods and worked with outsourcing groups to streamline the transfer of methods. Conducted independent research and presented at various scientific symposiums symposiums. Selected for committees to that led technology advancements, cross-organizational integration and team building implementation.

Master Of Science - Ms, Chemistry

Bachelor Of Science - Bs, Biochemistry

Curriculum Development Certification