Sujatha Kandasamy
Los Angeles,CA
Summary
Versatile Technical lead with over 20 years of pharmaceutical experience. Successful career in managing and supporting CMC operations, Clinical and commercial manufacturing. Proven ability to work with multifunctional teams to achieve focused results. Knowledge of 21 CFR with focus on parts 210, 211, 610 and 11. Great attention to detail, good technical writing and communication skills. Ability to influence others in decision making. Demonstrated lead in executing lean and continuous improvement projects. Able to collaborate and make timely decisions. In depth knowledge in technology transfer and manufacturing process.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Principal Quality Engineer, Sr Manager
BioDuro
04.2023 - Current
- Supported PD and tech. transfer of clinical stage small molecule, Phase I/II/III products.
- Collaborated with QA, Tech Service and PD teams to address quality problems.
- Provided Technical input for resolving process capability concerns.
- Managed clients, communications and inputs for manufacturing.
- Lead efforts for new equipment and instrument qualifications for quality.
- Collaborated with vendors and clients and addressed concerns successfully.
- Managed Deviations, CAPAs, effectiveness checks, Change control and reported out for QRB.
- Supported multiple client and FDA audits, responses and inspection readiness activities.
- Lead a 4 personnel team to address quality requirements.
Sr Engineer II, Technical Operations
Glaukos
01.2021 - 05.2022
- Tech transfer lead for CMC Phase III manufacturing and validation of commercial parenteral product.
- Lean commercial manufacturing preparation activities and transfer of product to manufacturing.
- Evaluated suppliers, changes, supported notification and quality agreements.
- Supported CMC documents authoring and review for NDA filing,
- Lead continuous improvement initiatives to streamline manufacturing process, reduce cycle time by 2 days.
- Conducted and drafted FMEAs and other risk assessments for new molecule introduction.
- Identified specification ranges for in process and implemented for PPQ as required.
- Performed statistical evaluations with CpK, control charts, regression and ANOVA.
Principal Validation Consultant
Captek/Teva Pharmaceuticals
06.2019 - 01.2021
- Represented QA validation for transfer of products to facility as part of CMC strategy.
- Minimized product risk by establishing risk assessment and implementing in process controls.
- Managed, provided reviews and mentored reporting quality personnel.
Manufacturing Specialist
Amgen Inc
03.2016 - 06.2018
- Responsible for owning, timely execution and closing quality systems, change records and deviations at biological facility.
- Conducted gap assessments and recommended specifications to minimize compliance risk and in line with quality standards.
Validation Specialist
Endo, Baxalta Inc
05.2015 - 12.2015
- Reviewed executed batch records for final dispositions of lot and product release.
Pharmaceutical Technology Specialist I/II/III
Actavis Inc
10.2005 - 01.2015
- Supported product introduction or transfers and improvement projects on site.
- Supported site goals with implementation of PAT technology, as part of Quality by Design initiative.
- Executed new raw material evaluations and implemented certificate of analysis specifications.
- Executed DOE and statistical analyses such as Cp, CpK, control charts and regression analyses using JMP.
- Supported CMC document preparation with source documents, reviewed sections for technical input and regulatory submission.
- Responsible for efficiency projects identifying, planning, determining milestones and execute project activities as part of operational excellence program.
- Awarded "best of class" by manufacturing operations for Corona site for 2010, 2011 and 2012 for exceptional performance of operations efficiency, cost saving and improvement projects.
- Successfully executed manufacturing efficiency projects with increased productivity and quality and provided savings of over $500,000/year for site
Education
Master of Science - Pharmaceutical Sciences
University Of Florida
Gainesville, FLMBA - Operations Management
University of Phoenix
Pomona, CABachelor of Science - Biology
York University
Ontario CanadaSkills
- Quality Engineering Principles
- Validation Methodologies
- Sterilization Methodologies
- Operational Excellence
- Project Management, Microsoft Project
- Trackwise, LIMS, EDMS, MAXIMO, Microsoft Office
- Technical Writing, FMEA
- Lean manufacturing, Six Sigma, Green Belt
- Statistical Analysis in JMP
Additional Information
Awarded “best of class” by manufacturing operations for Corona site for 2010, 2011 and 2012 for exceptional performance of operations efficiency, cost saving and improvement projects.
Certification
Certified Quality Engineer (ASQ)
Diploma in Pharmaceutical Manufacturing (TIPT)
Timeline
Principal Quality Engineer, Sr Manager
BioDuro
04.2023 - Current
Sr Engineer II, Technical Operations
Glaukos
01.2021 - 05.2022
Principal Validation Consultant
Captek/Teva Pharmaceuticals
06.2019 - 01.2021
Manufacturing Specialist
Amgen Inc
03.2016 - 06.2018
Validation Specialist
Endo, Baxalta Inc
05.2015 - 12.2015
Pharmaceutical Technology Specialist I/II/III
Actavis Inc
10.2005 - 01.2015
MBA - Operations Management
University of Phoenix
Bachelor of Science - Biology
York University
Master of Science - Pharmaceutical Sciences
University Of Florida
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