Janhavi Brahmbhatt

https://www.linkedin.com/in/janhavi-brahmbhatt/ +1-857-***-**** adzb0z@r.postjobfree.com SUMMARY

Leveraging my expertise in regulations, quality assurance, operations related to manufacturing in order to develop innovative & dynamic solutions that are transferable, drive revenue growth, and contribute to the success of the organization. Thus, supporting quality oversight and regulatory compliance. EDUCATION

Northeastern University, Boston, MA

M.S Regulatory Affairs April 2023

Courses: Drugs, and Medical Device law, Human Experimentation, Quality Assurance, QMS, Pharmacovigilance, Global impact of e-CTD, IDE regulations & clinical trial design, Regulatory Strategy for life-cycle management, Design controls & product development, Therapeutic product development.

NMIMS University Mumbai, India

MBA Pharma Tech. June 2020

Courses: Drug delivery systems, Pharmaceutics, Pharmacology, Biotechnology, Quality Assurance, QMS, Pharmacovigilance, Pharmaceutical testing, Pharmaceutical Marketing, Finance and Selling, Operations, and Supply Chain Management, Optional line of Entrepreneurship Management (Business Process implementation).

EXPERIENCE

Moderna

Manufacturing Associate 1 Present

• Routinely executing visual inspection, labeling, and packaging using disposable technologies and Manufacturing Execution Systems (MES)

• Demonstrating general knowledge of standard visual inspection practices and equipment.

• Tracking and reordering of all labeling and packaging materials by following the GMP, GCP & GLP Standards

• Performing DP activities for multiple drug product vial types and packaging configurations.

• Collaborating with Supply Chain and maintaining the inventory. Closely partnering with QA and QC peers for execution of drug product activities.

• Supporting the investigation and troubleshooting of technical and compliance issues. Maintaining the individual training compliance using the eQMS like Veeva Vault and SAP software, thus following the Good Documentation Practices.

• Following written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.

• Collaborating cross functionally adhering to the gowning procedures and maintaining clean room practices. Following the LEAN principles in order to create an RFT (right at first time) environment.

• Reviewing and inspecting of material prior to use for manufacturing processing packaging using disposable technologies and Manufacturing Execution Systems (MES). Initiating quality event for identified aberrant/non-aberrant material.

• Performing DP activities for multiple drug product vial types and packaging configurations. Notifying Global Quality and Compliance if defect is determined to be vendor related.

• Assessing materials in their respective areas when notified by Quality Assurance that another area has identified an aberrant material.

• Scrapping non-aberrant material in SAP, documenting on FRM-0309 and transferring to waste management.

• Labeling material with required information, coordinating an exchange of custody with SC Logistics to return aberrant material to the warehouse and store in a hold or reject controlled location.

• Completing the SAP transaction to create an Inbound delivery for material returned to the warehouse. Healthy Design Boston, MA

Capstone project intern - medical device January 2023 - April 2023

• Identified & determined whether the device is classified as a diagnostic (class I) or with decision support (class II).

• Developed an understanding of the product and devised a regulatory landscape (510K or a PMA submission)

• Determined potential pathways to regulatory approval for the device.

• Designed a strategic project plan starting from the regulatory requirements to the budget for the same. Novartis Healthcare Pvt Ltd Chennai, Mumbai, India Therapeutic Business Executive - Cardiovascular Division August 2020 - July 2021

• Reviewed and realized the company goals for the different quarters.

• Conducted market research, to identify the user needs & current market trends to supply the latest data to the cross-functional teams like RA/QA supporting their decision strategies.

• Reviewed and analyzed the data generated by previous campaigns & strategies to plan and implement a continuous improvement process for current and future campaigns.

• Monitored and analyzed the competitor’s strategy to generate data for structuring our strategies to increase sale volumes and overall product efficiency in the market.

• Organized & facilitated meetings with Cardiovascular Key Opinion Leaders (KOLs), where data was collected and analyzed to increase product penetration.

• Spearheaded a one-of-a-kind project in India by implementing Blue Ocean Marketing strategy - Involved a Pulmonologist, Physician and Cardiologist who discussed the patient journey of Heart Failure & viewpoint of 'dyspnea' leading to proper diagnosis.

• Developed marketing strategies by considering the pricing index, distribution challenges, demand-supply regime for new product launches.

• Collaborated with KOLs, including Cardiologists, Cardio-Thoracic Vascular Surgeons, and Physicians in Continuous Medical Education (CME), resulting in a 102% YOY Sales & Profit Margin increase and overall business growth.

• Identified a key strategic area and implemented an Integrated Hospital Strategy, increasing product penetration from 0-26% within two months and exceeding quarterly performance targets through distribution channels thus, monitoring the competition in the Cardiovascular market.

• Developed new account relationships in various regions by designing and executing innovative campaigns, while ensuring regulatory compliance with promotion and labeling requirements.

Omgene Life Sciences Pvt Ltd Vadodara, India

Technical Trainee May 2018 - June 2018

• Acquired a comprehensive understanding of the fundamental and detailed workflow of a pharmaceutical organization, with a focus on the production, manufacturing, and packaging of Active Pharmaceutical Ingredients (API) in a cGMP facility.

• Implemented and adhered to a batch disposition schedule, while tracking batch disposition metrics for COA/COC. Additionally, reviewed & approved end-to-end analyses of raw materials to finished API products and conducted QC testing.

• Collaborated with the development team to synthesize & purify the API using techniques such as Custom synthesis, Peptide synthesis, Bio conjugation, etc.

• Supervised the review of lab materials, guidance documents, & regulatory requirements for novel submission projects & plans for NCE's in the near future.

• Managed the reconciliation of method development and validation, GLP compliance, documentation, completeness, and compliance per FDA guidelines, following SOPs, protocols, QA compliance, and a review checklist. Academic Project

• Conducted a review on J&J Hip Implant recall case and developed a strategy to customize the quality management system (QMS) for a biomedical product and manufacturing environment based on FDA's expectations for 21 CFR 820 in product design control, quality system documentation, continuous improvement processes, and practical manufacturing principles.

• Analyzed and identified regulations related to EUDAMED for Electronic cigarettes in the EU by reviewing and generating a report on the Political Economy and Product Regulation, comparing it with the July 2013 draft (TPD) and RWD.

• Collaborated with the team and analyzed the CAPA and Design Control requirements for the Zimmer: the Gender Specific Knee replacement case while complying with the 510k regulations. Also, prepared a case briefing on the same.

• Prepared a regulatory strategy for a vaccine from pre-clinical to post-marketing stage, including designing and complying with 1571 form, 365h, meeting request, and meeting package for a BLA submission.

• Designed a letter from a consumer perspective on PDUFA reauthorization to the FDA Commissioner, highlighting the importance of safety and effectiveness of drugs for the consumers.

• Structured IND, protocol amendment, and annual report submission in accordance with ICH M4 CTD and FDA eCTD industry guidance.

• Compiled the Safety Reports, DSUR, Investigators Brochure, and other documents routinely submitted to FDA to ensure compliance with regulations.

Skills

• Technical acumen: Drug: IND, NDA, BLA, cGMP, cGCP, cGLP, QSR, ICH Guidelines, PFMEA & DFMEA, FDA Databases.

• Devices: 510(K), MDD 93/42/EEC - QSR 21 CFR 820, ISO 13485, ISO 14971, PMA, IDE, CAPA, Quality Management System, Design Controls, DHF, Root Cause Analysis.

• Computer skills: Syncade, SAP, Veeva, Smartsheet, Infobatch, MS Word, Excel, Power Point, Adobe Acrobat DC,

• Professional skills: strong analytical, sales operations, leadership, team building & teamwork, business relationship management, healthcare management, problem solving, organizational skills, collaboration and communication, presentation and meeting leading skills, Change control, personnel training.

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