Aphrodite Biswas
Research Development Process Engineer at i3 Pharmaceuticals, LLC- Claim this Profile
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English Native or bilingual proficiency
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Hindi Full professional proficiency
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Bengali Native or bilingual proficiency
Topline Score
Bio
Credentials
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Bachelor of Science in Chemical Engineering
Penn State UniversityDec, 2021- Nov, 2024
Experience
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i3 Pharmaceuticals, LLC
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Research Development Process Engineer
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Jan 2023 - Present
Process design, manufacture and optimisation of pilot scale, scale-up, medium to large scale production functions and processes for solid-oral dosage pharmaceutical products. Responsible for leading process evaluation studies and Process Performance Qualification of ANDA/NDA project, pre and post FDA approval. Specific on-the job process related responsibilities include, but are not limited to preparation and execution of batch manufacturing and packaging records, development of manufacturing and testing protocols for pre and post ANDA/NDA batches, hands-on application with pilot scale, scale-up and large scale equipments and processes such as blending, granulation, compression, coating of tablets, capsules etc. along with design and execution of scale-up and exhibit processes for manufacturing. Responsible for planning, managing, scheduling and executing all projects in development from scale-up stage all the way until FDA-approval. Also responsible for conducting process related Quality investigations, recording and mitigating deviations and implementing change control systems for manufacturing needs. Additional engineering responsibilities include validation, calibration and qualification for lab-scale and manufacturing scale equipment at the facility, cleaning procedure validation and verification. Regulatory experience and job responsibilities include preparation of technical documentation for regulatory submission (FDA), leading document control in the war-room during FDA pre-approval inspections and audits, for R&D and OP teams. Show less
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Process Development Scientist
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Jan 2022 - Jul 2023
Design, manufacture and optimisation large-scale production processes of solid-oral dosage pharmaceutical products. Execution of Process Performance Qualification of ANDA submissions post FDA approval. Specific job responsibilities include, but are not limited to preparation and execution of batch manufacturing and packaging records, development of manufacturing and testing protocols for pre and post ANDA submission batches, hands-on application with pilot scale, scale-up and large scale equipments and processes such as blending, granulation, compression, coating of tablets, capsules etc. Show less
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Process Development Intern
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Jun 2021 - Jan 2022
Responsible for facilitating the manufacture of Scale-up & ANDA batches of solid-oral dosage pharmaceutical products in cGMP environments in collaboration with Formulation Scientists and Production Operators. Involved in designing, optimizing and developing Process Validation batches for commercial clearance by the FDA. Gained experience with documenting batch manufacturing records, protocols, data analysis reports etc. for product manufacture.
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AIChE - American Institute of Chemical Engineers
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United States
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Non-profit Organizations
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700 & Above Employee
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Vice President
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Apr 2021 - Dec 2021
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Corporate Outreach Chair
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Apr 2019 - Jun 2021
Will be solely responsible for communicating with Corporate Sponsors of AIChE- Penn State Chapter, setting up corporate and factory tours within the Chemical, Pharmaceutical, and fuel industry for members and officers.
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Publicity Chair
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Aug 2018 - Apr 2019
In this role, I was responsible for all Outreach functions for the organisation
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Penn State University
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United States
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Higher Education
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700 & Above Employee
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International Student Orientation Leader
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Jun 2020 - Dec 2021
Welcoming International Students to Penn State and being a resource to them during this transition! Welcoming International Students to Penn State and being a resource to them during this transition!
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Penn State College of Engineering
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United States
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Higher Education
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100 - 200 Employee
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Research Assistant
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May 2020 - Dec 2021
Under the able guidance of Dr. Scott Milner, I am studying the interactions of a pore molecule with the shape of the bilayer membrane in which the pore is embedded in— through computational tools. The system in consideration has been biomimicked based on the family of water-channel protein Aquaporin, typically found in the human kidneys. The overarching purpose of this project is to create more effective membranes for large-scale water treatment. Studying the interactions of such polymer membranes is only a fundamental component of a larger project related to the same. Show less
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Research Assistant
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Jan 2020 - May 2020
Experimental research on sterile purification of vaccines by analysing the permeability of membranes variable with pressure or flux. Independently Performed permeability tests of membranes with buffers, performed a thorough literature review on related topics as a credit-based undergraduate research assistant under Dr. Andrew Zydney.
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University Park Undergraduate Association
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United States
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Civic and Social Organizations
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1 - 100 Employee
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Executive Director of Outreach
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May 2020 - May 2021
Head of the UPUA’s department of Outreach. Responsible for creating a direct line of communication between UPUA, the Penn State Student Body and all other stakeholders. Role is focused on organizing student engagement events, internal reform of the organization and being the point of contact for UPUA.
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Vice- Chair, Outreach
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Apr 2019 - May 2020
Responsible for reaching out to the student body of Penn State and hearing their needs to fulfil as an At-Large member of the Penn State Student Government. The role of vice-chair entails several big and small internal functions within the University Park Undergraduate Association alongside the main agendas of making the services of the student government known to the undergraduate body, and upholding the values of diversity and inclusion in the university.
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At-large representative
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Mar 2019 - Mar 2020
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Freshman Council Member
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Aug 2018 - Mar 2019
Position of a council member in the Penn State student government, to learn and benchmark university administration processes etc.
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Penn State SEDI
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United States
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Higher Education
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1 - 100 Employee
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Teaching Assistant
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Aug 2019 - May 2021
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Jubilant Pharmova Limited
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Summer Intern
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May 2019 - Aug 2019
This Internship includes training under the Chief Sustainability Officer of Jubilant Life Sciences Ltd., India; and working on different projects related to sustainability. This Internship includes training under the Chief Sustainability Officer of Jubilant Life Sciences Ltd., India; and working on different projects related to sustainability.
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Penn State University
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United States
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Higher Education
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700 & Above Employee
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Student Coordinator, Global Engagement Leadership Experience
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Feb 2019 - May 2019
In this role, I was responsible for facilitating and coordinating a group of students at GELE2019, a 3 day workshop for global leadership, to impart ways to be a global leader in the future and share my own experiences as a trainee before. I was chosen for this role post my excellent participation at the previous edition of the same workshop. In this role, I was responsible for facilitating and coordinating a group of students at GELE2019, a 3 day workshop for global leadership, to impart ways to be a global leader in the future and share my own experiences as a trainee before. I was chosen for this role post my excellent participation at the previous edition of the same workshop.
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Apeejay Stya Education (Svran Foundation)
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India
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Education Administration Programs
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200 - 300 Employee
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Director General, CRUX Model United Nations
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Apr 2017 - Mar 2018
The position is the functional head of the CRUX Secretariat. I was responsible for managing a team of about 80 staff members and also attracting participants to the first ever CRUX Model UN conference. The conference was extremely successful with over 350 delegates from across New Delhi Schools, and the first of its kind in the school. The position is the functional head of the CRUX Secretariat. I was responsible for managing a team of about 80 staff members and also attracting participants to the first ever CRUX Model UN conference. The conference was extremely successful with over 350 delegates from across New Delhi Schools, and the first of its kind in the school.
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Apeejay Stya Education (Svran Foundation)
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India
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Education Administration Programs
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200 - 300 Employee
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Student Editor, School Magazine
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Apr 2016 - Oct 2016
I was responsible for editing and short listing student submissions to the school magazine. The role also entailed formatting of the final print and its publication. I was responsible for editing and short listing student submissions to the school magazine. The role also entailed formatting of the final print and its publication.
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Education
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Penn State University
Bachelor of Science - BS, Chemical Engineering -
Penn State University
Bachelor's degree, Minor in Engineering Leadership Development -
Apeejay School
High School Diploma, Engineering Science -
Ryan International School
High School Diploma, Physical Sciences