Bagisha Maitra Email & Phone Number

Salt Lake City, Ut, Us

Cambridge, Ma, Us

Boston, Massachusetts, United States

● Lead, own, and author risk assessment, deviation, analytical/OOS investigation, CAPA, and change control processes to support manufacturing operations and drug product disposition.● Conduct comprehensive deviation investigations across manufacturing, QC, facilities, and supply chain processes, collaborating with cross-functional teams to drive root cause analysis and implement effective corrective actions.● Develop and execute risk assessments and mitigation plans by engaging and strategizing with stakeholders to identify, assess, and address complex indications and process/product risks to implement process improvements.● Manage the full lifecycle of deviations and associated quality records, managing timelines, driving collaboration to maintain accurate documentation and achieve timely event closure ensuring 100% regulatory compliance.

Greater Boston

-Develop, execute, and implement a robust and compliant APQR program that meets all regulatory requirements and Moderna Policies. Function as the APQR Process owner for MFG Site at Norwood -Author the APQR on an annual basis ensuring all elements are included and completed within the regulatory timelines. This includes data interpretation of analytical, manufacturing, and compliance data, and conclusions from real-time data and statistical reports. -Provide a documented review of key quality indicators with the support of Site SMEs to determine the need for changes in product or process specifications, manufacturing, or quality procedures and ensure alignment with filing. Verify the consistency of existing processes and highlight any trends.-Establish an internal process for the collection of data and information flow from all key quality systems and sources, including external QA, CMO, and suppliers, ensuring Data integrity principles are built into them -Establish a review/verification process with key SMEs for trends and determination of CAPAs for inclusion within the APQR. -Conduct annual assessment of the health of APQR Quality System, and maintain site APQR SOP/Work Instructions/Templates for managing the internal process, roles and responsibilities- Lead site Deviation metric trending initiatives, including evaluation of trends and implementation of actions through the Deviation Trend Report Program.-Participate in internal audit program and regulatory inspection programs at the Site-Lead and author comprehensive investigations. Collaborate with cross-functional stakeholders of QC, analytical development, manufacturing, and quality assurance to gather insights, conduct root cause analysis investigations, and identify solutions for deviations.-Conduct risk assessments by facilitating reviews with cross-functional leads to understand risks and to gather input on risk mitigations for specific risk assessments.

• Identified and implemented training solutions to address business challenges, increasing staff accountability. Revised employee training program, led periodic training sessions site-wide to support GMP readiness and continued regulatory compliance & engaged employees through improved methods. • Spearheaded efforts to improve department's percent right first time (%RFT) across various Quality systems by assuring full compliance with best practices SOPs, regulatory requirements (cGMP, GDocP, 21CFR210, 21CFR211) & maintain an organizational goal to be in a ‘GMP State of mind’. • Developed an expedited onboarding training schedule in collaboration with 9 inter-departmental supervisors & directors for 8 manufacturing personnel ahead of 3 GMP runs for 2 major iBio projects. Collaborated with Analytical Sciences as QA lead to manage Analytical Method Qualification/Validation.• Led a program to function as a QA liaison to periodically assess and manage QA service requests from a group of 10 cross-functional stakeholders.• Supported the redesign of the compliance investigation program for quality events with GMP impact by streamlining the tracking sheet, and overseeing an intern who was charged with the development of KPIs for all open and closed Events, Deviations, OOS, CAPAs & SCARs.• Managed and operated the Electronic Quality Management System (eQMS) TMS for document change control including but not limited to development, revision, archival, version control, impact assessments, training & job plan administration for 1500+ new and existing documentation both periodic and ad-hoc, during their document lifecycle. Handled an average 50 daily open activities via TMS. • Completed post execution review of ~250 documents (batch records, IQOQ, PQ, MQ reports, QC forms) in partnership with a co-worker.• Tracked and communicated weekly KPI (Key Performance Indicators) for document control & training.

• Managing the incoming material receipt, quarantine and release program, inspecting received material forms, finding and reviewing certificates of analysis and labelling. • Preparing and revising policies, standard operating procedures, and specification documents within the electronic document management system (TMS). • Operating the electronic Quality Management System software - TMS Quality Compliance Software, to assign job plan, manage trainings of operators and to control the review, approval, and release of documents as a responsible group administrator• Facilitating meetings and trainings regarding new or changing Quality processes as needed to establish facility wide goal of being in a constant cGMP State of mind.• Update record room catalog consistently to increase visibility and facilitate speedy information review \& retrieval.• Working closely with quality control, procurement, stakeholders and team members to achieve goals and objectives supporting QA compliance to meet business and customer needs. • Execute other projects as assigned by QA Supervisor.

Bryan/College Station, Texas Area

• Conduct primary and secondary market research to develop the commercial value proposition of new medical and biotechnology innovations of Texas A&M University.• Identify growth opportunities in the market and identify potential licensee, by analyzing competitive industry landscape and market trends.• Develop extensive market viability reports, develop proposals for how to capture value and provide recommendations for next steps.• Assist in early stage business creation, financing, licensing, and strategic planning.• Consult and negotiate with various stakeholders to analyze their roles and acquire capital budgeting.• Act as a liaison between inventors, licensing associates and potential licensees, and generate scientific-business communication materials.

College Station, Texas, United States

• Assist with the invention disclosure evaluation process• Perform primary market, secondary market, and intellectual property landscape research• Prepare market, IP, and commercialization assessments• Support business development activities• Assist with other special projects as assigned

College Station, Texas, United States

• Managed the IBIO-200/201 COVID-19 vaccine development project,through overarching Gantt charts and communication with various stakeholders.• Spearheaded successful client management and revenue recognition for the company, by tracking project progress and deliverables for 2 key clients.• Assess man-hours time, resources and materials needed for each project.• Program management by working closely within internal sub-groups like R&D, process development, analytical & clinical research, manufacturing, quality, procurement, finance and legal.• Conduct regular project team meetings & communicate project status to project leads , internal leadership and external stakeholders.• Develop agendas and materials, and drive execution for key internal and external milestone meeting and 11 weekly assigned meetings.

Hyderabad Area, India

• Recipient of a competitive fellowship, awarded on the basis of the rank received in a competitive exam, Graduate Aptitude Test in Engineering (GATE), with a total of 10,611 candidates, to engagein a research project , funded by the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT), Government of India joint grant.• Aim of the project to study immune responses to fungal eye infection (IL-22 mediated ocular host defense against A. flavus keratitis). Harvested conidia and cultured A. flavus isolates (repeated 11 times) to standardize the in-vitro infection culture model. • Further studies are being carried on in the lab with a broader goal of finding therapeutic intervention.

Kolkata Area, India

• Selected in the yearly Summer Student Programme (SSP) run by SINP in which 50 students across the country are chosen on the basis of academic records and letters of recommendation, participate in research and developmental work under the supervision of a faculty or a research staff and received a stipend for the tenure. • My project in the Crystallography and Molecular Biology lab involved working with two proteins, a C-D1-GMP phosphodiesterase called Eal protein and an endonuclease called MutH protein from Vibrio Cholerae 0395. The target proteins were overexpressed by IPTG induction in E.coli BL21 followed by purification of the protein via the Ni-NTA affinity chromatography. The proteins were further purified using size exclusion chromatography. Protein drops were set for crystallization trials. • Structural and functional studies of these proteins were carried out in the future based on these results.

Master'S Degree, Biotechnology Management - Mbiot, Business Of Life Science, Gpa As Of Fall '20 Semester : 4.00/4.00

Activities and Societies: Vice President, Biotechnology Society, TAMU, College Station.The Master of Biotechnology Program (MBIOT) is.

Master Of Science - Ms, Human Physiology, Gpa : 3.87/4.00 (Wes Evaluation)

•Spearheaded research project in the Molecular Virology laboratory on detection of norovirus in collected common street food items. •.

Bachelor'S Degree, Human Physiology, Gpa : 3.67/4.00 (Wes Evaluation)

• Led a field survey to assess the physiological and anthropometric parameters of about 60 school children, in the high-land areas of West.

High School, Stem