Shyam Shrestha
Peabody
Summary
Results-driven professional with extensive experience at GSK-Affinivax, specializing in process optimization and quality control. Successfully increased production capacity and enhanced OTIF from 60% to 95%. Proven ability to train and mentor teams, ensuring compliance with GMP documentation and ethical work standards. Strong background in SAP implementation and cross-functional collaboration.
Overview
7
7
years of professional experience
Work History
Principal Associate (formally Senior Associate)
GSK-Affinivax
Cambridge
04.2022 - Current
- Leading the team for buffer and DS production.
- Cross functionality with QA, MSAT, FEV, QC, and PD Departments.
- Conducted logbook and batch reviews to ensure compliance and accuracy.
- Implemented SAP system for improved operational efficiency.
- Validated equipment to meet industry standards and specifications.
- Supported eight cleanroom operations with 20 operators during phases one to three of DS production in Grade C.
- Increased production capacity and enhanced OTIF from 60% to 95% through resource optimization.
- Facilitated training for new hires, ensuring readiness for Tier 1 and Tier 2 responsibilities.
- Delivered presentations at board meetings to communicate progress and initiatives.
- Led MBR logbook blitz initiative to minimize backlog using Visual Management techniques.
Senior Associate
Affinivax
Cambridge
04.2022 - 01.2023
- MAPS Operation in clean room.
- SOP’s writing, reviews, OJT writing and training.
- Assisted QC efforts for EMPQ.
- Assist Process Development team to run their operation.
- TFF setup and operation.
- Perform MAPS on TFF & filtration.
- Polysaccharides & Biotinylating reaction.
- Making Buffer solution & filtration.
- Support cleanroom laboratories build, first production batches as well for toxicology and PD studies.
Manufacturing Associate
Platelet Bio
Watertown
07.2021 - 02.2022
- IPSC Culture and Differentiation.
- Tawing, 2D expansion, cryopreservation.
- 3D Differentiation, Megakaryocytes, and Banking.
- Drug product manufacturing.
- Assist with TFF and bioreactor kit assembly.
- Familiar with the basics of the TFF process.
- Assist in the creation of GMP documentation and SOP protocol.
- ISO Class 5 cGMP clean room operation performed.
- Assist the Process Development team with internal cell production.
- Media and buffer are being made to support the R&D process.
- Involved in the manufacturing team hiring process.
Micro-optical Technician
Thermo Fisher Scientific
Tewksbury
06.2018 - 06.2021
- Spectrometer reading for electronic devices.
- Laser count, peak value, graph in clean room.
- Assembly of micro-optical lenses for RAMAN technology.
- Successfully trained multiple people and prepared them for the manufacturing group.
- Review and improve the SOP protocol, and submit it for QA approval.
- 5S Development Action.
Education
Biotechnology and Compliance Certificate Program -
Quincy College
Quincy, MA01.2019
Associate Degree - Business Administration
Quincy college
Quincy, MA01.2012
Skills
- Ethical work standards
- SAP implementation
- Process optimization
- Quality control
- Training facilitation
- Attention to detail
- Training and mentoring
- Schedule management
- Team supervision
- Cross-functional teamwork
- GMP documentation
- Process improvement
Relevant Courses Experience
- Completed over 300 hours of hands-on lab time, with hands on skills.
- SOP Writing, cGMP documentation, FDA regulations (21 CFR210/211)
- Chromatography
- Biomanufacturing- Applikon Bioreactor
- SDS Page, Protein purification
- Agarose Gel electrophoresis
- Spectrophotometry, Aseptic Skills and Technique.
- Autoclaving, Buffer & Media preparation
References
Available upon request
Timeline
Principal Associate (formally Senior Associate)
GSK-Affinivax
04.2022 - Current
Senior Associate
Affinivax
04.2022 - 01.2023
Manufacturing Associate
Platelet Bio
07.2021 - 02.2022
Micro-optical Technician
Thermo Fisher Scientific
06.2018 - 06.2021
Biotechnology and Compliance Certificate Program -
Quincy College
Associate Degree - Business Administration
Quincy college