Simrat Kaur
San Ramon,CA
Summary
Experienced Reagent Manufacturing Manager with a responsibilities of leader in pharmaceutical clinical lab operations and product development. Experienced professional adept at leading projects from inception to FDA approval while ensuring compliance. Proven track record of successfully managing multiple projects and ensuring accurate test results. As a motivational leader, I consistently exceed expectations and possess strong skills in problem-solving, team building, and operational excellence. I am experienced in mentoring and training team members, and I excel at building solid relationships across all levels of an organization to achieve business goals. Additionally, I have a history of stepping into roles and quickly making positive changes to drive company success. My focus is on using training, monitoring, and morale-building techniques to maximize employee engagement and performance.
Overview
16
16
years of professional experience
Work History
Manager (Reagent Manufacturing Operations)
Guardant Health
Redwood City, CA
01.2019 - Current
- Oversaw multi-lab daily operations, running multiple projects, ensuring efficient workflows, inventory management, and resolving technical and non-technical issues.
- Managed reagent manufacturing operations, including production kit assembly for patient testing, reagent qualification, and adhering to cGMP and GDP standards.
- Lab compliance and FDA compliance
- Leadership communication, and matrics and work, how you initiate new projects? how are you executing and aligning with company vision???
- xxx budget ???
- Coached and mentored team members, providing training, feedback, and skill development to improve job performance.
- Collaborated with cross-functional teams (Quality Assurance, Clinical Operations, Supply Chain, etc.). To consistently supply qualified reagents.
- Led risk management activities, including FMEA analysis and coordination of process controls.
- Coordinated IQ/OQ/PQ with the service engineering team for manufacturing equipment, ensuring compliance with quality standards.
- Maintained laboratory inventory, ensuring availability of reagents, supplies, and equipment.
- Coordinated scheduling for manufacturing activities and tracked project metrics, effectively communicating progress.
- Supported supply chain coordination and provided technical assistance to the Reagent Manufacturing team.
- Developed SOPs, managed NCR processes, and continuously facilitated investigations to improve quality and operational efficiency.
- Led team meetings and one-on-one coaching sessions, communicated priorities, and promoted team development.
- Evaluated, hired, and trained staff to maintain coverage, resolve conflicts, and foster a positive team culture.
- Implemented new processes and technologies to streamline operations and improve productivity.
- Maintained accurate documentation of processes, quality control, and team activities to support compliance and performance.
Senior Reagent Manufacturing Associate
Fluidigm
South San Francisco, CA
12.2018 - 01.2019
- Prepared necessary reagents for manufacturing operations, ensuring readiness for production in compliance with ISO 13485:2003 and ISO 9001:2008.
- Managed formulations and performed tube fillings using automated systems like Hamilton Microlab STAR and Biomek 2000, including troubleshooting equipment issues.
- Conducted reagent testing utilizing pH meters, conductivity meters, and osmometers, with proficiency in pipetting techniques and raw material allocation.
- Conducted bulk formulation, tube/plate filling, and kit assembly to meet production timelines, maintaining ISO and GMP compliance.
- Maintained and operated various lab equipment, including centrifuges, TC20 cell counter, Zeiss microscope (Primo Vert), pH meters, and autoclaves.
- Ensured effective cell culture management, including cell counting and preparing formulations.
- Updated laboratory notebooks in LIMS, managed batch records, and archived them with scanning and verification processes.
- Performed validations of lab equipment and developed corresponding operational procedures.
- Supported GMP documentation, internal audits, and inspections; participated in the review of SOPs, batch records, and testing protocols.
- Maintained accurate inventory of raw materials, ensured sufficient stock levels, and followed up on supply needs to meet production goals.
- Prepared buffers and solutions in accordance with specific protocols, while adhering to GMP standards.
- Operated in compliance with regulatory requirements and Good Manufacturing Practices for reagent production.
- Conducted regular equipment maintenance and ensured proper handling and disposal of hazardous materials, according to safety regulations.
- Assisted in troubleshooting manufacturing issues and optimized production efficiency.
- Provided training and guidance to junior technicians and newly hired team members on lab equipment usage, safety practices, and company standards.
- Acted as a team lead by supervising junior staff during production activities and addressed any quality control or compliance issues in a timely manner.
Senior Research Assistant
Ardelyx
Fremont, CA
02.2017 - 08.2017
- Supported scientists by conducting experiments aimed at optimizing API forms in formulations and analyzing excipient compatibility, ensuring optimal drug development outcomes.
- Executed comprehensive DOEs covering the full development lifecycle, from granulation to tableting/encapsulation, preparing formulations for successful scale-up at Contract Manufacturing Organization (CMO) sites.
- I played a key role in establishing the solid dosage lab, ensuring it met operational and regulatory standards, and developing methodologies for consistent output.
- Conducted extensive experiments utilizing various analytical techniques (DVS, DSC, HPLC, pH meter, water activity, QICPIC), ensuring stability and compliance with FDA guidelines for API forms.
- Compiled and analyzed experimental data, utilizing Electronic Laboratory Notebooks (ELN) for reporting, supporting the generation of scientific publications and reports.
- Assisted in method development for various analytical instruments, optimizing lab processes, and ensuring adherence to industry standards.
- Coordinated with vendors for equipment procurement, facilitated training for team members, and validated new equipment through Installation Qualification (IQ), Operational Qualification (OQ), Calibration Qualification (CQ), and Performance Qualification (PQ).
- Ensured compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Trained in quality assurance (QA) processes for change control using Veeva systems, maintaining high lab operations standards.
- Served as Safety Coordinator for the solid dosage lab, overseeing equipment cleanliness, label accuracy, and reporting findings in safety meetings with corrective action plans.
- Participated in weekly team meetings to report on progress and align on project goals. Facilitated communication with excipient vendors, ensuring smooth material procurement.
- Led audits and implemented quality control measures for data collection, equipment maintenance, and study protocols to ensure accuracy and compliance.
- Oversaw compliance with Good Clinical Practices (GCP) and HIPAA regulations, ensuring all research activities adhered to ethical and legal standards.
- Set up, calibrated, and maintained laboratory equipment, ensuring accuracy for ongoing experiments and compliance with study requirements.
- Provided training to team members on properly using laboratory equipment and QA processes, fostering a collaborative and efficient work environment.
Research Assistant
PPD at Genentech
South San Francisco, CA
05.2014 - 02.2017
- Supported the development of high-quality solid dosage formulations through proficient handling of various laboratory equipment and devices.
- Participated in setting up a new lab for a start-up team through equipment procurement, surrogate testing, and Standard Operating Procedures (SOPs) creation.
- Evaluated the impact of excipients on tablet properties through DOE for optimized tablet formulations.
- Facilitated efficient laboratory operations by utilizing Electronic Lab Notebook (ELN) to document and report on lab results.
- Assisted in coordinating study activities by tracking progress and milestones for timely completion of projects.
- Determined key equipment parameters according to batch size for scaling production from bench to pilot.
- Developed inventory catalog to streamline research and formulation processes.
- Collaborated cross-functionally for introducing innovative technologies, resulting in improved excipient compatibility and substantial time savings in formulation development.
- Contributed towards the precise results of experimental procedures through assisting in the setup, calibration, and maintenance of laboratory and field research equipment.
- Contributed to team meetings by updating on project progress and generating ideas for future research directions.
- Engaged in continuous learning by completing additional training and courses to remain updated on industry advancements and best practices.
- Maintained laboratory cleanliness and safety through regular maintenance of lab space and equipment to prevent contamination with hazardous materials.
Quality Assurance
Impax Laboratories
Hayward, CA
05.2008 - 06.2013
- Operated, assembled, and cleaned various tablet presses and encapsulation machines
- Trained and qualified colleagues as an SME
- Established governing documents to aid in regulation
- Followed GMP guidelines
- Performed qualification runs for both a Fette 1200i tablet press and a Fette 2200i tablet press
- Assisted in preparing, reviewing, and executing batch records, SOPs and regulatory documents
- Optimized process efficiency for direct compression process trains
- Maintained all the equipment in the lab, scheduled, and hosted preventive maintenance visits
- Investigated deviations and executed IRs
- Prepare CAPA documentations in QMS
- Trained on QA process for AQL on the tablets and releasing the batch and internal audits
- Review labels for FDA compliance and recommended appropriate changes
- Performed duties of acting lead in absence of the team lead.
Education
Bachelor’s in Computer Application -
Punjab Technical University
Skills
- Great Communicator
- Good Listener
- Critical Thinker
- Leadership qualities
- Staff Development
- Operations Management
- Strategic Planning
- Performance Management
- Schedule Preparation
- Cross-functional team management
- Verbal and written communication
- Performance Evaluations
- Cross-Functional Teamwork
- Staff Training and Development
- Project Management
- Team Leadership
- Budget Control
Additionalcertificationsandseminars
- Certification in Lean manufacturing and Six Sigma
- Compaction Seminar Short Course - Antonio Zavaliangos, 2016
- Certification in Certified Pharmacy Technician Professional Career Institute Development - Atlanta, GA
- Certification in FL-M-3CI FLO-COATER System
- Certification of Completion Gerties Roller Compactor Lecture Seminar
- Smart sheet Certification (IP)
Lab & Tools
LIMS, ELN, Empower, Lab Planning, Quickbase, Google docs, Bulk/tap density, Disintegration, Formulatrix, Centrifuge, Bravo, Vantages, Hamilton Star, Elite (Capper / Decapper), Cybio Labeler, Microscopy – Nikon Eclipse LV100N (Polarized), Zeiss AX10, Friability/Abrasion & Jenike & Johansen Fluidization, Dry Granulation Alexanderwerk, Gerteis MiniPactor, LOD – Mettler Toledo, pH Meter – Thermo Fischer Orion Star A211, TA Instruments – DSC25 and Q5000 SA (DVS), Ring Shear Testing, Howard Isolators, Microsoft Excel, MS Project, PowerPoint, Microsoft office Suite, Smartsheet & Google Sheets, Jira & Confluence, Quickbase
Languages
English
Native/ Bilingual
Hindi
Full Professional
Punjabi
Full Professional
Urdu
Limited
Timeline
Manager (Reagent Manufacturing Operations)
Guardant Health
01.2019 - Current
Senior Reagent Manufacturing Associate
Fluidigm
12.2018 - 01.2019
Senior Research Assistant
Ardelyx
02.2017 - 08.2017
Research Assistant
PPD at Genentech
05.2014 - 02.2017
Quality Assurance
Impax Laboratories
05.2008 - 06.2013
Bachelor’s in Computer Application -
Punjab Technical University
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