Smera K. is a Product Development Coordinator at Adero.
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Product Development CoordinatorAderoLos Angeles, Ca, Us -
Project Management, Regulatory Operations, & Biostatistics InternUrogen Pharma Jun 2024 - PresentPrinceton, New Jersey, United States• Conducted Quality Control (QC) reviews for documents due for New Drug Application (NDA) submissions to the FDA• Developed a comprehensive content plan for all documents required in NDA submission, streamlining the documentation process• Collected and organized all references cited in Common Technical Documents (CTD), ensuring proper documentation and traceability using Veeva• Utilized Python to create a graphics library for biostatistical analysis, enhancing visualization capabilities for data interpretation• Gained expertise in single-arm trials and generated Kaplan-Meier plots, Power Analysis Curves, Chi-Square Tests, and Fisher’s Exact Tests using Python and R -
Physics Campus Peer Learning FacilitatorUcla Jan 2024 - PresentLos Angeles, California, United States• Held 6 hours of weekly tutoring sessions, mentoring underclassmen in topics ranging from kinematics, electromagnetism, and circuits• Supported 15-20 students each quarter, enhancing their confidence in the material• Designed custom worksheets and led review sessions for midterms and finals -
Manufacturing & R&D InternSun Pharma Jun 2023 - Aug 2023New Brunswick, New Jersey, United States• Led a pivotal project aimed at establishing the ideal exhaust temperature for two key products, eliminating the reliance on operators’ subjective drying time assessments. Analyzed and optimized drying parameters, including inlet temperature, drying time, dew point, and Loss on Drying (LOD) values from Manufacturing Batch Records to develop a data-driven approach for setting optimal exhaust temperatures• Employed a comprehensive analysis that incorporated seasonal variations in temperature, specifically focusing on dew point measurements. By understanding how these variations impacted the outlet temperature, provided operators with a robust framework to precisely control the fluidized bed dryer process in granulation, resulting in improved efficiency, product quality, and reduced dependency on manual interventions• Performed crucial assay, content uniformity, and dissolution tests in both R&D for the development of new generic products, and in QC to release Certificates of Analysis, ensuring the batch’s compliance with quality standards• Rewrote Standard Operating Procedures (SOP) for banding machines, incorporated guidelines for new scales and balances, and integrated procedures for a newly acquired laser drilling machine, ensuring standardized and efficient operations in compliance with Good Manufacturing Practice (GMP) policies -
Commercial Operations, Supply Chain, Market Access InternUrogen Pharma Jun 2022 - Sep 2022Princeton, New Jersey, United States• Implemented automated processes for shipment orders, supply chain timeline notifications, and reimbursement account processes through Smartsheet and Smartforms, reducing manual processing time by 70%• Spearheaded the project to launch a tracking device integrated into drug delivery packages. Facilitated enhanced communication to empower pharmacies with timely information on drug arrival, optimizing patient care. Addressed logistical challenges, determining optimal placement of the tracking device within cold packages to ensure uninterrupted functionality and drug preservation• Crafted training materials for accessing new data platforms on a third-party website. Acquired proficiency in the platform and created a comprehensive PowerPoint presentation, ensuring seamless onboarding and utilization of the new system -
Logistic Chair, Evening With Industry CommitteeSociety Of Women Engineers At Ucla Oct 2021 - Jun 2022• Spearheaded UCLA’s largest student-run networking event hosting around 30 companies, fostering crucial industry connections for students.• Designed a comprehensive template slide-deck for company representatives to enhance presentation uniformity• Collaborated with the Internal Director to organize event logistics, ensuring seamless execution• Demonstrated adaptability by swiftly transitioning from an in-person to an online platform due to challenges posed by the COVID pandemic
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Member, ChipAmerican Institute Of Chemical Engineers At Ucla Oct 2021 - Jun 2022• Led a team project focused on designing a coffeemaker, presenting the prototype to Chemical Engineering department representatives• Developed Arduino code for ultrasonic sensors to detect cup fullness, optimizing coffee dispensing• Utilized 3D printing to create aesthetically pleasing molds housing sensors and hardware components• Managed project trajectory, fostering team discussions on budgeting and deadlines to ensure successful execution
Smera K. Education Details
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Chemical Engineering -
Northern Burlington County Regional High School
Frequently Asked Questions about Smera K.
What company does Smera K. work for?
Smera K. works for Adero
What is Smera K.'s role at the current company?
Smera K.'s current role is Product Development Coordinator.
What schools did Smera K. attend?
Smera K. attended University Of California, Los Angeles, Northern Burlington County Regional High School.
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