Swathilekha Chivukula
Acton,USA
Summary
Experienced Senior Specialist with a strong track record in project management, data analysis, and strategic planning. Proven ability to lead and mentor teams, driving business growth while ensuring quality and compliance. Recognized for exceptional problem-solving skills and effective communication, which have consistently enhanced operational efficiency and team performance. Committed to delivering high-quality results in fast-paced environments while seeking opportunities for continuous process improvement.
Overview
18
18
years of professional experience
Work History
Senior Specialist
Vertex Pharmaceuticals
Boston
10.2023 - 11.2024
- Support overall manufacturing operations (from stem cell to patient dosing) and lead various operations/projects for type I diabetes program at vertex cell and gene therapy center
- Conducted value streaming of VX880 and VX264 T1D programs
- Support with MBRs, SOPs, WIs, CAPAs, Deviations, Change controls, etc
- Support process development team with tech transfers
- Completed 35hour PMP training
Business Support Specialist (contract)
Sciex
Framingham
10.2022 - 09.2023
- Support overall Demo-lab operations and provide Applications support
- Ensure smooth functioning of all the 10 demo labs and LC’s and Mass specs in the demo lab and conduct regular maintenance and testing
- Conduct weekly demo lab group meetings
- Ensure labs operate under EH&S guidelines and generate SOPs
- Generate monthly revenue reports
- Experience working with Actio, Oracle, Salesforce, Chem
- Inventory, & Scheduling
- Assist with customer trainings
Scientist
Advanced Instruments
Norwood
04.2022 - 10.2022
- Supported sales and marketing, R&D, & customers through data, internal projects, research reports and white papers
- Helped clients analyze their complex and ‘hard-to-analyze’ samples
- “Back-up” demo person to showcase clients Advanced Instruments products & services
- Recommend right product after understanding customer needs
- Projects in charge
- Led a benchmarking study to compare competitor products with our current instruments
- Performed IQ/OQ/PQ on AI instruments as a part of the study
- A review on the impact of osmolality in formulation development
Research Scientist II
Comera Life Sciences
Woburn
10.2021 - 03.2022
- Led efforts for new equipment purchase, assessed value add, usability, etc
- Coordinated times with the manufacturer (Unchained labs), arranged demos and follow up discussions
- Led efforts to transition the entire company from lab notebooks to an electronic lab notebook (ELN)
- Participated in obtaining Quality management systems
- Planned and conducted stability studies, carried out characterization, maintenance and troubleshooting of instruments
- Characterization techniques: BCA, SDS -Gel, SEC&IEX (including maintenance and troubleshooting), DLS
Scientist (contract)
Alnylam Pharmaceuticals
Cambridge
03.2021 - 09.2021
- Conducted routine testing mRNA formulations & provided formulation support for ongoing programs
- Generated qualification reports and protocols; ensured ELN entries were made, generated certificate of Testing (CoTs)
- Transcribed testing results into CoTs and reports
- Assays: appearance, pH, osmolality, Karl fisher, UV assays, Tm, Molar extinction coefficient methods
Technical Writer (contract)
Tunnell Consulting, Inc.
Watertown
11.2020 - 01.2021
- A 10-week project to Revise SOPs, create new SOPs for equipment and take SOPs through our client's review process
QC Specialist
BioAgilytix
Boston
02.2020 - 09.2020
- Ensure highest quality of the out-going data to sponsors and clients
- Act as a liaison between the Research team and the QA
- Ensure all data analysis, reports, validation methods, sample analysis plans, standard operating procedures are reviewed
- Maintain communication with Project Management, Research team and other team members in Quality Control about incoming projects and ensure deliverables are met
- Communicate QC findings with the Research team and Project management
- High importance placed on handling conflicting deadlines and organizational skills
- Initiate deviations when required
Development Specialist (contract)
TAKEDA
Lexington
09.2018 - 01.2020
- Conducted development and stability studies from Phase 1-III & commercial stages for VPRIV (used for enzyme replacement therapy)
- This program mainly targeted development of a high concentration formulation from an already available drug product
- Developed protocols for various studies, design of experiments (DoE), performed various assays (pH, Osmolality, Appearance, MFI, SEC assays), analyzed the data and summarized data and scientific findings in presentations and reports
- Part of the investigation team to investigate issues observed in clinical stage
Research Associate (contract)
SANOFI
Framingham
01.2018 - 08.2018
- Conducted stability studies on commercial mAb-based formulations and assisted in selection of final formulation for an Oncology drug
- Characterization carried out using different analytical instrumentation
- Assays: pH, Concentration, CE-SDS, Osmolality, Density, Refractive index
Chemistry teacher (contract)
Milford High School
Milford
01.2017 - 04.2017
- Taught chemistry to over 100 students in courses including honors chemistry, college preparation, and concepts of chemistry levels
- Conducted parent-teacher conferences, conducted labs, graded exams, tests & classwork/homework
- Ensured student accountability
Advanced Research Scientist
FM GLOBAL
Norwood
08.2008 - 08.2015
- Conducted research in material failure analysis, smoke characterization, corrosion science, and polymer degradation & characterization studies
- Smoke Damage Research Program to quantify damage caused by smoke from fires: Spearheaded the ‘bubbler project’ to develop a method to capture acid-gases generated in case of smoke and fires
- Validated developed techniques and generated a standard operating procedure
- Corrosion Mitigation of Fire Protection Sprinkler System: Developed simple, cost-effective corrosion mitigation strategies to prevent leakage and failure of fire protection systems
- Drafted written standards and strategies for implementation at client locations
- Conducted literature review and analysis to develop strategies to restart frozen aluminum smelter cells
- Plastics (CPVC) Degradation: Analyzed detrimental effects of sunlight and UV light on CPVC in weathering chambers
- Applied results for further work on seismic application of CPVC sprinkler piping systems
- Drafted protocols, reports, and SOPs and conducted data analysis and process investigations
- Drafted written summaries of scientific results broadly to FM Global technical staff
- Worked in collaboration with internal teams and Engineering standards
- Participated in cross-site and cross-functional meetings, actively built relationships with direct teams and shared data and knowledge within teams
- Managed Polymer Research Lab; supervised and carried out protocols for lab safety and EH&S compliance
- Trained lab personnel in using lab equipment, analytical methods and/or SOPs
- Supervised and maintained laboratory instrumentation and systems
- Supported lab documentation, safe operation & conduct in laboratories
- Conducted analytical activities in Failure Prevention Team
- Worked on projects systematically to help clients within and outside the organization, with the goal being loss prevention and loss mitigation
- Conducted research using standard chemical characterization methods and analytical tools like IC, CE, XRF, FT-IR, ChemStation, UV-Vis, TD-GC-MS, Gas Analyzers, O2 sensors, Weathering instruments (QUV, Q-SUN, Q-FOG), Titrations, TGA, DSC, Keyence Microscope, Zeiss Metallograph, SEM, and EDX in polymer research lab, analytical lab, corrosion science lab and materials lab
- Drafted over 50 written risk service reports that provided tailored quick turn-around solutions to clients requesting for forensic analysis on failed fire protection systems and loss prevention strategies
Research/Teaching Assistant
University of Massachusetts
Boston
08.2006 - 08.2008
- M.S
- Thesis: Tandem Mass Spectrometry of ammoniated triglycerides: Arachidonic acid containing TAGs and standard plots for positional analysis of YYX/YXY TAG systems
- Taught undergraduate organic chemistry, taught and supervised general chemistry labs of up to 45 students, and graded exams
- Conducted outreach efforts to local Boston high school students as member of Boston Science Partnership outreach program
- Assisted high school students from different schools with chemistry lab experiments and explained concepts to enhance achievement
- Collaborated with high school teachers to prepare quizzes, and supervised lab experiments to significantly improve the quality of BPS science teachers
Education
M.S. - Chemistry
University of Massachusetts
Boston01.2008
B. Tech - Chemical Technology
Institute of Chemical Technology
India01.2006
Skills
- Innovation management
- Maintenance and repair
- Failure management
- Business reporting
- Vendor relations
- Technical communication
- Continuous improvement
- Documentation management
- Management collaboration
- Root-cause analysis
- Quality assurance
- Analytical thinking
- Team performance improvement
- Compliance monitoring
- Equipment calibration
- Troubleshooting techniques
- Machinery maintenance
- System installations
- Process optimization
- Stakeholder engagement
- Team collaboration
- Coaching and mentoring
- Quality assessment
- Knowledge sharing
- Operational enhancement
- Schematics interpretation
- Customer relations
- Risk management
- Supply management
- Resource allocation
- Technical troubleshooting
Publications
- Judge, E.J; Zheng, D.; Chivukula, S; Gakwaya, R.; Schostarez, S.; Li, X.; Liriano, M.; Evans, J.J.;
- ; A Simple and Economical Strategy for Obtaining Calibration Plots for Relative Quantification of Positional Isomers of YYX/YXY Triglycerides using High Performance Liquid Chromatography Tandem Mass Spectrometry, Rapid Commun. Mass Spectrom.2017
- Su, P.; Chivukula, S.; Tatar, F.W.; Swinnerton, B.; Corrosion of Sprinkler Piping Under Compressed Nitrogen and Air Supervision. In NACE International 2015, Dallas, TX, March 15-19, 2015.
- Chivukula, S.; Su. P.; Degradation of CPVC Sprinkler Piping Material by Simulated Sunlight and UVB Light; National Meeting of the American Chemical Society Fall 2013 & Fall 2014; Division of Polymer Chemistry.
- Newman, J. S.; Su, P.; Yee, G.G.; Chivukula, S.; Development of smoke corrosion and leakage current damage functions. Fire Safety J. 2013, 61, 92–99.
- Su, P.; Tatar, F.W.; Chivukula, S.; Doerr, W.W.; Weld Seam Corrosion of Steel Sprinkler Pipe. In Corrosion 2013, Orlando, FL, March 20, 2013.
- Gakwaya, R.; Li, X.; Wong, Y.L.; Chivukula, S.; Collins, E.J.; Evans, J.J.; Examining the collision-induced decomposition spectra of ammoniated triglycerides. III. The linoleate and arachidonate series. Rapid Commun. Mass Spectrom.2007, 21, 3262-3268.
References
References available upon request.
Timeline
Senior Specialist
Vertex Pharmaceuticals
10.2023 - 11.2024
Business Support Specialist (contract)
Sciex
10.2022 - 09.2023
Scientist
Advanced Instruments
04.2022 - 10.2022
Research Scientist II
Comera Life Sciences
10.2021 - 03.2022
Scientist (contract)
Alnylam Pharmaceuticals
03.2021 - 09.2021
Technical Writer (contract)
Tunnell Consulting, Inc.
11.2020 - 01.2021
QC Specialist
BioAgilytix
02.2020 - 09.2020
Development Specialist (contract)
TAKEDA
09.2018 - 01.2020
Research Associate (contract)
SANOFI
01.2018 - 08.2018
Chemistry teacher (contract)
Milford High School
01.2017 - 04.2017
Advanced Research Scientist
FM GLOBAL
08.2008 - 08.2015
Research/Teaching Assistant
University of Massachusetts
08.2006 - 08.2008
M.S. - Chemistry
University of Massachusetts
B. Tech - Chemical Technology
Institute of Chemical Technology
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