Marissa Callahan Email & Phone Number

Boston, Ma, Us

Business Operations- R&D Transaction SME, manage contracts, POs, and invoices, to ensure accounting, project spending and budgeting accuracies, provide regular office hours, training sessions and guides catered towards business needs.- Oversee CAPEX ordering across DDS US and ensuring IT/facilities/lab ops are aware and accommodate for the requirements for the new equipment while maintaining budget compliance.- Support employee onboarding by providing necessary resources, setting up computers with appropriate software and account access, and collaborating with R&D partners to enhance the onboarding process overall.- Coordinate with facilities and space planning to organize office areas pre- and post-renovation, arrange office and lab workstations, and address issues with equipment, furniture, and connectivity.- Lead the Co-op program for DDS Chemistry team and provided support for setting up the program for OTAU.- Continue to consult and troubleshoot DDS Chemistry’s formulation challenges.Informatics and Technical support- Provide informatics support for the team when needed (automatic data transfer and backup for various lab instruments, SharePoint, connectivity, and network issues)- Designed and maintain DDS and DDS Chemistry SharePoint by procuring information and resources and updating the site to be relevant, accessible, and intuitive, increasing self-sufficiency and search efficiency.- Work extensively with Takeda IT, SI and vendors for major infrastructure update, including software and hardware updates, ELN migration and GENI protocols, Windows 10 migration, network drive migration. Fix any gap Takeda IT missed during these updates including managing data transfer and backup during network drive migration for continuous workflow and seamless transition, permission, network, accessibility, and lab interface issues with DOC computers and various issues overlooked in the roll outs.

Manage formulation development across multiple drug discovery programs, implementing a scalable and user-friendly process for formulation request and fulfillment.- Partnered with the Medicinal chemistry, biologist, DMPK, and DPD teams in developing formulations and lipid nanoparticles, based on solubility, stability, dose, and dosing route of the compounds, and oversaw method transfer to external CRO and provide support throughout the entirety of the studies.- Analyzed long-term formulation stability studies on key compounds that are routinely use for in vivo studies to explore the possibility of streamlining the process and minimize exposure to potent compounds.Provide analytical support to various departments, including developing methods for analyzing lipid nanoparticles composition, instrument maintenance, service and troubleshooting, test physicochemical properties of compound and training colleagues to do the same.- Learned and developed scripts for high throughput automation to create reagent library and future collaboration.Cross Functional Management- Created a user friendly and streamlined request system for various assays offered by the analytical team for characterizing new compounds.- Set up remote access to the analytical instruments allowing the team to monitor and control the instrument remotely and connected them to the network allowing for easy data transfer from local drive to network drive.- Updated training documents, ROPs, data generating and reporting templates including bug fix and coding errors to automate the process as much as possible, minimizing amount of copy and pasting and manual data entering.- Organized and led morale-boosting activities for teams during the COVID-19 shutdown, including yoga classes and contributing as a chemistry representative to the internal newsletter, fostering a positive work culture.

Boston, Ma

General Assembly's 12-week Web Development Immersive course provides full-stack web development training.Store mApp- Developed single page application that allows user to create a shopping list which sorts automatically based on the layout of the store.- Built with React, Node JS, and Rails back end.Xobpord- Single page application that allows user to upload files into an AWS file bucket.- Built using JavaScript with HTML/CSS/Handlebars front end, MongoDB, AWS (S3) back end.- Group project using pair programing, took the lead in planning, front end/UI. Dive Log- Developed front-end JavaScript application, with HTML and CSS, and rails API from scratch. - Application provides secured login with user authentication and record various dive information.- Allow user to create and keep track of their diving excursionsFirst Project: Tic-Tac-Toe- Single-page application which allow users to log in and keep track of numbers of games played- Utilized HTML, CSS, JavaScript, jQuery, and bootstrap to create the front end- Ajax call through a third party API for CRUD functionality for the back end

Pharmaceutical DevelopmentSpearhead formulation development for the early drug discovery program. - Created a formulation screening process to increase efficiency and improve turnaround time for pre-clinical in-vivo studies.- Developed an FFP HPLC method to streamline pre-clinical formulations analysis.- Coordinated interdepartmental work flow between Chemistry, Biology and Analytical Development.Key contributor in the development of clinical formulations for lead candidates.- Designed and executed mock clinical tests for clinical candidates including evaluation of formulation compatibility with various administration sets. - Devised lyophilization studies to improve formulations in preparation of dose escalation and Phase II clinical studies.- Assisted with writing up Clinical Pharmacy Manuals.- Authored reports in support of IND filings.Assisted in making nanoparticles demonstrating POC for improving efficacy of lead candidates.Additional responsibilities include lab organization and management, waste management, safety committee membership, IATA and DOT certification for shipping hazardous goods.

Discovery Pharmaceutical Sciences (Characterization and Pre-formulation Development)Initiated characterization of potential pre-clinical drug candidates’ physiochemical properties.- Streamlined solubility analysis and improved efficiency of the process.- Implemented a formulation screening and evaluation process for oral and inhalation dosing in vivo.Participated with technical training and on-boarding for interns, including introduction to analytical method development and analysis.Managed chemical and physical stability studies for API at various stages of development.Performed routine instrument maintenance for all of the instruments in the laboratory.Maintained laboratory supplies including chemicals, buffers, and dosing vehicles.

Formulation DevelopmentExecuted, analyzed and presented experiments and results towards developing solid dosage forms.- Performed blend optimization to support design of experiment (DOE) studies for line extension activities for both high dose and pediatric formulations.- Conducted direct compression and granulation optimization experiments key to reviving projects placed on hold.- Implemented powder and tablet characterization, including flow, density, tensile strength, hardness and friability.Provided analytical support for projects requiring immediate attention and tight timelines.Developed templates for electronic lab notebook documentations for departmental use.Created reports in support of NDA filings.

Formulation DevelopmentAnalytical DevelopmentLead the effort in introducing automated dissolution technology to the company.- Carried out dissolution studies to determine the bioavailability of the early development candidates (EDCs) in order to better understand and formulate drug product for pre-clinical animal studies.- Streamlined dissolution practices to improve the data integrity and the efficiency of the experiments.- Designed dissolution methods mimicking the in vivo effects to compare immediate release versus modified release profiles of the EDCs.- Troubleshot, trained and supervised colleagues with instrument operation.Executed experiments to improve the bioavailability of EDCs.- Conducted lipids and excipients screening for potential drug product formulations.- Developed formulations for various dosing methods for pre-clinical animal studies evolving with the direction of the company.- Modified traditional tabletting strategies to fit the needs and processes carried out internally.Designed experiments crucial in supporting clinical trials, compound storage, distribution and testing.- Developed HPLC methods which reduced waste and improved efficiencies by 60%- Implemented physical and chemical stability studies and solubility of drug substance and drug product.

Analytical DevelopmentPerformed method development and validation for analytical analysis of drug substance and drug product- Validated the accuracy and precision of methods developed for HPLC and GC analysis- Conducted assays, related substance analysis, residual solvent, stability studies, potency and content uniformity of drug substance and product- Troubleshot HPLC, GC, and Headspace GCPlanned and performed experiments key to the investigation of the behavior of the API under clinical trials.- Executed dissolution studies to determine the stability of the API in order to help formulate the most effective composition in creating final drug products.Directed training activities for interns, including routine analysis, dissolution studies, assessment of purity, potency and content uniformity for both drug substance and product.

General Chemistry and Organic Chemistry laboratory

General Chemistry laboratory

Conducted extensive analytical experiments for several projects: - Elucidated the metabolism of arsenic in E. coli; arsenic extraction and speciation from E. coli by solid phase extraction (SPE), microwave digestion, and HPLC-MSIS-ICP-OES (with and without hydride generation).- Evaluated speciation of arsenic contaminated water and soil samples using SPE and analyzing the samples using flow-injection hydride generation atomic absorption spectroscopy (FI-HG-AAS).Served as a senior student advisor for the arsenic independent research study program, a program aimed to expose students to the laboratory research environment

Biochemistry and Molecular Biology laboratory

Conducted experiments with gene expression and mitochondrial biogenesis - Deleted SRB10 gene in yeast (Saccharomyces cerevisiae) to allow the testing and comparison of its enzymatic activities with the parental and mutant strains.

Master Of Science, Bio-Analytical Chemistry

Activities and Societies: University of Massachusetts Track and Field

Bs, Bs, Chemistry, Biochemistry And Molecular Biology, And Biology

Activities and Societies: University of Massachusetts Track and Field: top 5 triple jumper in school history, University of Massachusetts.

Full Stack Web Development

Web development immersive course covering HTML, CSS, JavaScript, Ruby, Rails and more.