Benjamin R. Svoboda has over 10 years of experience developing, validating, automating and transferring analytical methods like bioassays and ELISAs in pharmaceutical quality control laboratories. He has a strong background in cell-based and immunochemistry assays and has automated many methods using the Tecan Freedom EVO platform. Currently he works as a quality consultant, helping companies like Amgen automate analytical testing globally.
This document provides information on Phillip Bishop's extensive 13 years of experience in quality control and laboratory leadership roles. It outlines his skills and expertise in areas such as endotoxin testing, analytical testing techniques, authoring regulatory documents and standard operating procedures, batch record review, and laboratory management. His most recent role was as Group Leader and Subject Matter Expert in endotoxin testing at Baxter BioPharma Solutions, where he oversaw quality testing, assisted clients, and managed a team of analysts.
Mallikharjuna rao N. has over 9 years of experience in pharmaceutical quality assurance and analytical testing. He currently works as a Scientist II at Novartis Healthcare in Hyderabad, India, where he is responsible for method validation, clinical stability projects, documentation, and review of analytical reports. He has also worked at Mylan Laboratories and several other pharmaceutical companies. Mallikharjuna rao has expertise in HPLC, GC, dissolution testing, and other analytical techniques. He holds a Ph.D. in pharmaceutical analysis and quality assurance from Jawaharlal Nehru Technological University.
Scaling up industrial microbial processes is a complex endeavor that requires careful planning and execution to be successful. It involves increasing laboratory-scale processes to full commercial production levels over many years and at a high financial cost. If not approached properly, scale-up can lead to underperformance, delays, and project failure. To scale up successfully, one must begin with a clear vision of the final commercial process, be diligent in considering all critical details, and prepare for unexpected challenges that may arise.
Tyris Worthy is seeking a position as a lab technician or engineer. She has over 15 years of experience working in medical laboratories and has strong skills in chemistry, hematology, microbiology, and other lab areas. Her resume outlines her technical abilities such as performing various tests, operating laboratory machines, and her experience coding and processing specimens. She aims to provide quality and accurate work for her future employer.
This document provides guidance for GMP inspectors on inspecting sterility testing facilities and methodology. It covers key areas like clean room requirements, environmental monitoring, personnel training, sampling, and test details. The goal is to promote a consistent approach to sterility testing inspections and ensure tests are performed under optimized conditions to recover any microorganisms present. Recommendations include class A laminar flow cabinets in class B clean rooms, disinfecting surfaces, validating cleaning procedures, and defining action limits for environmental monitoring.
Leslie M. Henson-Grochocki has over 15 years of experience in quality control and laboratory operations. She has worked at Amgen Inc. for over 11 years, holding several roles of increasing responsibility, where she developed and validated assays, implemented new inventory systems, and led process improvement projects. She has a demonstrated track record of applying Lean and Six Sigma methodologies to achieve efficiencies and has received multiple awards for her contributions.
Ronald Preibis has over 17 years of experience in the biotech field, including extensive experience in all aspects of cell culture and purification. He has worked in manufacturing roles at several biotech companies, leading teams and supervising processes. His experience includes process development, cGMP manufacturing, analytical testing, documentation, and ensuring regulatory compliance. He is pursuing additional education in life sciences and biomedical laboratory sciences.
Diteba is a cGMP/GLP pharmaceutical laboratory located near Toronto, Canada that offers analytical R&D services including method development and validation, bioanalytical testing, quality control release testing, stability testing, and in vitro release testing. The company has over 10,000 square feet of laboratory space equipped with state-of-the-art instrumentation. Diteba's team of senior scientists have extensive experience across various therapeutic areas and analytical techniques.
This document provides information on Phillip Bishop's extensive 13 years of experience in quality control and laboratory leadership roles. It outlines his skills and expertise in areas such as endotoxin testing, analytical testing techniques, authoring regulatory documents and standard operating procedures, batch record review, and laboratory management. His most recent role was as Group Leader and Subject Matter Expert in endotoxin testing at Baxter BioPharma Solutions, where he oversaw quality testing, assisted clients, and managed a team of analysts.
Mallikharjuna rao N. has over 9 years of experience in pharmaceutical quality assurance and analytical testing. He currently works as a Scientist II at Novartis Healthcare in Hyderabad, India, where he is responsible for method validation, clinical stability projects, documentation, and review of analytical reports. He has also worked at Mylan Laboratories and several other pharmaceutical companies. Mallikharjuna rao has expertise in HPLC, GC, dissolution testing, and other analytical techniques. He holds a Ph.D. in pharmaceutical analysis and quality assurance from Jawaharlal Nehru Technological University.
Scaling up industrial microbial processes is a complex endeavor that requires careful planning and execution to be successful. It involves increasing laboratory-scale processes to full commercial production levels over many years and at a high financial cost. If not approached properly, scale-up can lead to underperformance, delays, and project failure. To scale up successfully, one must begin with a clear vision of the final commercial process, be diligent in considering all critical details, and prepare for unexpected challenges that may arise.
Tyris Worthy is seeking a position as a lab technician or engineer. She has over 15 years of experience working in medical laboratories and has strong skills in chemistry, hematology, microbiology, and other lab areas. Her resume outlines her technical abilities such as performing various tests, operating laboratory machines, and her experience coding and processing specimens. She aims to provide quality and accurate work for her future employer.
This document provides guidance for GMP inspectors on inspecting sterility testing facilities and methodology. It covers key areas like clean room requirements, environmental monitoring, personnel training, sampling, and test details. The goal is to promote a consistent approach to sterility testing inspections and ensure tests are performed under optimized conditions to recover any microorganisms present. Recommendations include class A laminar flow cabinets in class B clean rooms, disinfecting surfaces, validating cleaning procedures, and defining action limits for environmental monitoring.
Leslie M. Henson-Grochocki has over 15 years of experience in quality control and laboratory operations. She has worked at Amgen Inc. for over 11 years, holding several roles of increasing responsibility, where she developed and validated assays, implemented new inventory systems, and led process improvement projects. She has a demonstrated track record of applying Lean and Six Sigma methodologies to achieve efficiencies and has received multiple awards for her contributions.
Ronald Preibis has over 17 years of experience in the biotech field, including extensive experience in all aspects of cell culture and purification. He has worked in manufacturing roles at several biotech companies, leading teams and supervising processes. His experience includes process development, cGMP manufacturing, analytical testing, documentation, and ensuring regulatory compliance. He is pursuing additional education in life sciences and biomedical laboratory sciences.
Diteba is a cGMP/GLP pharmaceutical laboratory located near Toronto, Canada that offers analytical R&D services including method development and validation, bioanalytical testing, quality control release testing, stability testing, and in vitro release testing. The company has over 10,000 square feet of laboratory space equipped with state-of-the-art instrumentation. Diteba's team of senior scientists have extensive experience across various therapeutic areas and analytical techniques.
This document provides a summary of a dashboard and reflective review presentation from 2019. It discusses various quality topics related to pharmaceutical manufacturing including assay testing of APIs, use of preservatives, microbial limits, process validation, cleaning validation, API testing responsibilities, and more. Key points emphasized include using a risk-based approach to assessing changes and product holds, ensuring sampling methods are scientifically sound, and the importance of evaluating cleaning procedures to maintain ability to clean. Recent regulatory guidance from EMA regarding evaluation of nitrosamines is also summarized.
This document summarizes Shawn Lee's objective of obtaining a scientific position utilizing his training and knowledge in areas like pharmaceutical quality control, research and development, and manufacturing. It lists his technical skills in chromatography, spectroscopy, and immunoassay. It then summarizes his work experience from 1989 to present in analytical roles for companies like Johnson & Johnson, Organon, and Roche, involving tasks like method development, validation, out of specification investigations, and computer systems.
Hangzhou Just Biotherapeutics (HJB) is a CDMO located in Hangzhou, China that provides integrated development and manufacturing services from early-stage to commercial launch. It has 110 employees and facilities including 2000L bioreactor capacity. HJB utilizes an H.DESIGN platform to rapidly develop biotherapeutics using advanced processes. It has a seasoned leadership team with experience at top companies. Services include cell line development, upstream and downstream processing, analytics, formulation, technology transfer, and regulatory support.
This document is a resume for Tang N Nguyen, who has over 25 years of experience in pharmaceutical product development, formulation, and manufacturing. They have extensive experience developing formulations across multiple dosage forms including inhalation, ophthalmic, parenteral, and diagnostic products. Their resume highlights leadership roles with increasing responsibility in product development, technology transfer, manufacturing, and ensuring quality and regulatory compliance. They have a proven track record of successfully developing formulations from early stages through commercialization.
Pranav Champaknath Attavar completed a summer internship at Esjay Pharmaceuticals LLC in their Research and Development department. The report provides an overview of the internship, including descriptions of the quality assurance, quality control, product development, and research and development departments. It discusses methods used like dissolution studies and loss on drying tests. Results are analyzed using techniques like HPLC, UV, and GC to characterize drugs. The internship provided an understanding of analytical development and instrumentation used in product development.
This document discusses guidelines and best practices for handling out-of-specification (OOS) analytical results. It outlines procedures that regulatory agencies like the FDA recommend for investigating OOS results, including performing a preliminary assessment, full laboratory investigation, and documenting findings. The document emphasizes that OOS results should not be invalidated without a thorough investigation to identify the root cause and prevent future errors.
This document summarizes discussions from a conference on continuous biomanufacturing. Key presentations discussed Amgen's goal of 5 g/L productivity using intensified processes, and the FDA's support for continuous manufacturing. Conference participants also discussed different continuous approaches like steady-state perfusion and dynamic perfusion. Integrating upstream and downstream processes continuously is an area still needing investigation. The best approach depends on a company's existing infrastructure and product portfolio.
This document is a resume for Wendy Blanda, who has over 20 years of experience in pharmaceutical product development, formulation, and outsourcing. She has expertise in sustained release delivery systems, managing project teams, and ensuring successful scale-up and technology transfer. Some of her accomplishments include outsourcing formulation development for five projects, implementing a quality by design strategy, and championing a new formulation that enabled patients to receive a more tolerable treatment. She currently works as an Associate Director of Formulation Technologies.
VerGo Pharma provides contract research and manufacturing services to pharmaceutical companies to help meet their R&D goals. They have state-of-the-art facilities in Goa, India approved by regulatory agencies. Their services include formulation development, analytical testing, clinical studies, custom synthesis, and GMP manufacturing. VerGo aims to partner with clients and provide innovative solutions through quality services and technologies to help advance drug development.
Shikha Sharma has over 6 years of experience in quality control and R&D for pharmaceutical and biologics companies. She has expertise in cGMP quality systems, environmental monitoring, process development, cell culture, assay development and validation. Her technical skills include microbiology testing, media preparation, stability studies, and cell banking. She is proficient in cGMP documentation and has experience transferring technologies from R&D to manufacturing.
Michael A. Saavedra seeks a position utilizing his education and skills in science, including experience with various lab techniques and software. He has over 10 years of experience in roles such as Scientist at Roche Molecular Systems, Research Assistant at Johnson & Johnson Pharmaceuticals, and Laboratory Technician at Unilever. Saavedra's responsibilities have included writing validation protocols and reports, testing on multiple platforms, project leadership, reagent procurement, data analysis, and independently running assays. He is proficient in techniques like PCR, cell culture, and dilution schemes.
Maha Rizk has over 10 years of experience in biotechnology research, specializing in oncology biomarkers and drug development. She has expertise in assay development, cell culture, protein analysis, and data analysis. Currently she is a Senior Associate Scientist at Amgen developing assays to investigate biomarkers for cancer and inflammation.
Rajendra Balaso Kolape has over 13 years of experience in quality control and analytical development with companies like Johnson & Johnson, Ranbaxy Labs Ltd., and Cipla focusing on raw material analysis, stability testing, method development and validation, instrument qualification, and audit management. He currently holds the role of Group Leader - Clinical Release & Stability at Janssen and has a Master's degree in Chemistry, with a goal of excelling in analytical and related research to ensure business success and patient safety.
Janet Willis has over 10 years of experience in analytical chemistry and quality assurance. She holds a B.S. in Chemistry from UC San Diego and has worked at various pharmaceutical companies performing analytical testing, method development and validation, quality control, and quality assurance activities. Her experience includes HPLC, GC, UV-Vis, ELISA testing and method troubleshooting. She is proficient in GLP, GCP, and cGMP regulations and analytical software programs.
Robert Sereno has 10 years of experience in food safety, quality assurance, and laboratory management. He holds a B.S. in Chemistry and seeks a managerial position where he can utilize his scientific background and communication skills. Sereno has a proven track record of implementing food safety systems, analyzing process data, and leading laboratory operations and staff.
Anam Rodríguez Vega has over 15 years of experience as a senior laboratory analyst and medical technologist with expertise in hematology, chemistry, urinalysis, microbiology, serology, and blood banking. She is currently a laboratory supervisor overseeing clinical testing and staff. Prior experience includes managing laboratories, performing quality control, and ensuring compliance with regulations. She has a bachelor's degree in medical technology and an associate's degree in natural sciences.
Fully-Integrated Services for Global Therapeutics Development: Accelerating Progress and Time to Market with integrated CDMO Platforms and Laboratory Testing Services. WuXi Advanced Therapies leverages decades of laboratory testing experience to get your product to market faster and with greater predictability, by overcoming common industry constraints.
Sapna Yadav has over 3 years of experience in life sciences and biotechnology industries. She currently works as a Quality Control Lead at ThermoFisher Scientific, where she oversees manufacturing processes and product quality. Previously she has worked as an Associate Manufacturing Technician synthesizing DNA, and has internship experience in clinical research. She has a Bachelor's degree in Biological Sciences and certification in clinical trial monitoring.
This document summarizes the experience and qualifications of Raymond P Damien. It outlines his extensive experience in analytical chemistry techniques such as HPLC, UPLC, electrophoresis, and chromatography. It also details his experience in areas such as assay development, validation, automation, cGMP environments, and data analysis. Recent experience includes roles at Selecta Biosciences and Ocular Therapeutix developing analytical methods and drug delivery formulations.
Aida Melendez has over 30 years of experience in the pharmaceutical industry as a chemist, manager, and environmental project manager. She has expertise in areas such as manufacturing operations, quality assurance, laboratory management, and regulatory compliance. She is bilingual in English and Spanish and has a proven track record of managing teams and projects. She holds a B.S. in Chemistry and additional certifications in bioscience technology and quality systems.
Oscar Lara has over 12 years of experience in pharmaceutical research and development, holding positions at companies such as Regeneron Pharmaceuticals, Ortho-Clinical Diagnostics, and Hoffmann-La Roche where he conducted assays, managed projects, trained staff, and ensured compliance with regulations. He holds a Master's and Bachelor's degree in Biology from Fairleigh Dickinson University and has skills in areas such as ELISA, cell culture, data analysis, and laboratory software.
Susan Cho Hicks has over 20 years of experience in clinical laboratory operations and management, specializing in molecular diagnostics and next generation sequencing. She currently serves as the Associate Director of Laboratory Operations at Sequenom Laboratories, where she oversees daily operations, quality management, and expansion of the non-invasive prenatal testing laboratory. Prior to this, she held various clinical laboratory roles with increasing responsibility at other companies developing technologies in oncology and infectious disease testing.
This document provides a summary of a dashboard and reflective review presentation from 2019. It discusses various quality topics related to pharmaceutical manufacturing including assay testing of APIs, use of preservatives, microbial limits, process validation, cleaning validation, API testing responsibilities, and more. Key points emphasized include using a risk-based approach to assessing changes and product holds, ensuring sampling methods are scientifically sound, and the importance of evaluating cleaning procedures to maintain ability to clean. Recent regulatory guidance from EMA regarding evaluation of nitrosamines is also summarized.
This document summarizes Shawn Lee's objective of obtaining a scientific position utilizing his training and knowledge in areas like pharmaceutical quality control, research and development, and manufacturing. It lists his technical skills in chromatography, spectroscopy, and immunoassay. It then summarizes his work experience from 1989 to present in analytical roles for companies like Johnson & Johnson, Organon, and Roche, involving tasks like method development, validation, out of specification investigations, and computer systems.
Hangzhou Just Biotherapeutics (HJB) is a CDMO located in Hangzhou, China that provides integrated development and manufacturing services from early-stage to commercial launch. It has 110 employees and facilities including 2000L bioreactor capacity. HJB utilizes an H.DESIGN platform to rapidly develop biotherapeutics using advanced processes. It has a seasoned leadership team with experience at top companies. Services include cell line development, upstream and downstream processing, analytics, formulation, technology transfer, and regulatory support.
This document is a resume for Tang N Nguyen, who has over 25 years of experience in pharmaceutical product development, formulation, and manufacturing. They have extensive experience developing formulations across multiple dosage forms including inhalation, ophthalmic, parenteral, and diagnostic products. Their resume highlights leadership roles with increasing responsibility in product development, technology transfer, manufacturing, and ensuring quality and regulatory compliance. They have a proven track record of successfully developing formulations from early stages through commercialization.
Pranav Champaknath Attavar completed a summer internship at Esjay Pharmaceuticals LLC in their Research and Development department. The report provides an overview of the internship, including descriptions of the quality assurance, quality control, product development, and research and development departments. It discusses methods used like dissolution studies and loss on drying tests. Results are analyzed using techniques like HPLC, UV, and GC to characterize drugs. The internship provided an understanding of analytical development and instrumentation used in product development.
This document discusses guidelines and best practices for handling out-of-specification (OOS) analytical results. It outlines procedures that regulatory agencies like the FDA recommend for investigating OOS results, including performing a preliminary assessment, full laboratory investigation, and documenting findings. The document emphasizes that OOS results should not be invalidated without a thorough investigation to identify the root cause and prevent future errors.
This document summarizes discussions from a conference on continuous biomanufacturing. Key presentations discussed Amgen's goal of 5 g/L productivity using intensified processes, and the FDA's support for continuous manufacturing. Conference participants also discussed different continuous approaches like steady-state perfusion and dynamic perfusion. Integrating upstream and downstream processes continuously is an area still needing investigation. The best approach depends on a company's existing infrastructure and product portfolio.
This document is a resume for Wendy Blanda, who has over 20 years of experience in pharmaceutical product development, formulation, and outsourcing. She has expertise in sustained release delivery systems, managing project teams, and ensuring successful scale-up and technology transfer. Some of her accomplishments include outsourcing formulation development for five projects, implementing a quality by design strategy, and championing a new formulation that enabled patients to receive a more tolerable treatment. She currently works as an Associate Director of Formulation Technologies.
VerGo Pharma provides contract research and manufacturing services to pharmaceutical companies to help meet their R&D goals. They have state-of-the-art facilities in Goa, India approved by regulatory agencies. Their services include formulation development, analytical testing, clinical studies, custom synthesis, and GMP manufacturing. VerGo aims to partner with clients and provide innovative solutions through quality services and technologies to help advance drug development.
Shikha Sharma has over 6 years of experience in quality control and R&D for pharmaceutical and biologics companies. She has expertise in cGMP quality systems, environmental monitoring, process development, cell culture, assay development and validation. Her technical skills include microbiology testing, media preparation, stability studies, and cell banking. She is proficient in cGMP documentation and has experience transferring technologies from R&D to manufacturing.
Michael A. Saavedra seeks a position utilizing his education and skills in science, including experience with various lab techniques and software. He has over 10 years of experience in roles such as Scientist at Roche Molecular Systems, Research Assistant at Johnson & Johnson Pharmaceuticals, and Laboratory Technician at Unilever. Saavedra's responsibilities have included writing validation protocols and reports, testing on multiple platforms, project leadership, reagent procurement, data analysis, and independently running assays. He is proficient in techniques like PCR, cell culture, and dilution schemes.
Maha Rizk has over 10 years of experience in biotechnology research, specializing in oncology biomarkers and drug development. She has expertise in assay development, cell culture, protein analysis, and data analysis. Currently she is a Senior Associate Scientist at Amgen developing assays to investigate biomarkers for cancer and inflammation.
Rajendra Balaso Kolape has over 13 years of experience in quality control and analytical development with companies like Johnson & Johnson, Ranbaxy Labs Ltd., and Cipla focusing on raw material analysis, stability testing, method development and validation, instrument qualification, and audit management. He currently holds the role of Group Leader - Clinical Release & Stability at Janssen and has a Master's degree in Chemistry, with a goal of excelling in analytical and related research to ensure business success and patient safety.
Janet Willis has over 10 years of experience in analytical chemistry and quality assurance. She holds a B.S. in Chemistry from UC San Diego and has worked at various pharmaceutical companies performing analytical testing, method development and validation, quality control, and quality assurance activities. Her experience includes HPLC, GC, UV-Vis, ELISA testing and method troubleshooting. She is proficient in GLP, GCP, and cGMP regulations and analytical software programs.
Robert Sereno has 10 years of experience in food safety, quality assurance, and laboratory management. He holds a B.S. in Chemistry and seeks a managerial position where he can utilize his scientific background and communication skills. Sereno has a proven track record of implementing food safety systems, analyzing process data, and leading laboratory operations and staff.
Anam Rodríguez Vega has over 15 years of experience as a senior laboratory analyst and medical technologist with expertise in hematology, chemistry, urinalysis, microbiology, serology, and blood banking. She is currently a laboratory supervisor overseeing clinical testing and staff. Prior experience includes managing laboratories, performing quality control, and ensuring compliance with regulations. She has a bachelor's degree in medical technology and an associate's degree in natural sciences.
Fully-Integrated Services for Global Therapeutics Development: Accelerating Progress and Time to Market with integrated CDMO Platforms and Laboratory Testing Services. WuXi Advanced Therapies leverages decades of laboratory testing experience to get your product to market faster and with greater predictability, by overcoming common industry constraints.
Sapna Yadav has over 3 years of experience in life sciences and biotechnology industries. She currently works as a Quality Control Lead at ThermoFisher Scientific, where she oversees manufacturing processes and product quality. Previously she has worked as an Associate Manufacturing Technician synthesizing DNA, and has internship experience in clinical research. She has a Bachelor's degree in Biological Sciences and certification in clinical trial monitoring.
This document summarizes the experience and qualifications of Raymond P Damien. It outlines his extensive experience in analytical chemistry techniques such as HPLC, UPLC, electrophoresis, and chromatography. It also details his experience in areas such as assay development, validation, automation, cGMP environments, and data analysis. Recent experience includes roles at Selecta Biosciences and Ocular Therapeutix developing analytical methods and drug delivery formulations.
Aida Melendez has over 30 years of experience in the pharmaceutical industry as a chemist, manager, and environmental project manager. She has expertise in areas such as manufacturing operations, quality assurance, laboratory management, and regulatory compliance. She is bilingual in English and Spanish and has a proven track record of managing teams and projects. She holds a B.S. in Chemistry and additional certifications in bioscience technology and quality systems.
Oscar Lara has over 12 years of experience in pharmaceutical research and development, holding positions at companies such as Regeneron Pharmaceuticals, Ortho-Clinical Diagnostics, and Hoffmann-La Roche where he conducted assays, managed projects, trained staff, and ensured compliance with regulations. He holds a Master's and Bachelor's degree in Biology from Fairleigh Dickinson University and has skills in areas such as ELISA, cell culture, data analysis, and laboratory software.
Susan Cho Hicks has over 20 years of experience in clinical laboratory operations and management, specializing in molecular diagnostics and next generation sequencing. She currently serves as the Associate Director of Laboratory Operations at Sequenom Laboratories, where she oversees daily operations, quality management, and expansion of the non-invasive prenatal testing laboratory. Prior to this, she held various clinical laboratory roles with increasing responsibility at other companies developing technologies in oncology and infectious disease testing.
SJA CV Training Certificates and Work Presentation 15-Apr-18Shareef Jarvi Antar
Shareef Jarvi Antar has extensive experience developing and validating bioanalytical methods using various analytical techniques such as LC/MS, LC/MS/MS, GC/MS, and ELISA. He has worked for major pharmaceutical companies and CROs developing methods for pharmacokinetic studies, determining drug metabolism and metabolites, and evaluating drug-drug interactions. Currently he is an application chemist for IBL International setting up an LC/MS laboratory and developing automated methods using their equipment.
Lisa Grimm has over 15 years of experience developing, optimizing, and validating various immunoassays, cell-based assays, and coagulation assays. She has worked in immunology, oncology, haemostasis, and biologics at several pharmaceutical companies. Currently she is a research scientist at Tandem Labs developing and validating immunoassays like ADA and neutralizing antibody assays under GLP regulations.
The document provides a summary of Samha Lacoul's qualifications for a position as a laboratory technician or scientist. It outlines their technical skills and experience in areas such as HPLC, cell culture, quality control/assurance, and using various laboratory equipment and software programs. It also lists their education credentials and over 4 years of professional experience in quality control roles at pharmaceutical companies performing analytical testing and ensuring compliance with regulations.
This curriculum vitae summarizes the qualifications of Mohana Rangan, including education, language skills, computer skills, experience operating analytical instruments, training programs attended, and professional experience conducting chemical analysis and validating test methods. Mohana has 9 years of experience in an instrumentation role, operating various LC-MS/MS, GC-MS/MS, HPLC, GC, and other analytical instruments to analyze veterinary drug residues, pesticides, and other chemicals in food, water, and pharmaceutical samples.
Dilip Shah is seeking a position in pharmaceutical research utilizing his skills in laboratory instrumentation and assays. He has over 15 years of experience in compound management, high-throughput screening, and assay operations at major pharmaceutical companies. His technical skills include automated liquid handling systems, fluorescence and luminescence detection instruments, and assay techniques for targets such as ion channels, kinases, and phosphodiesterases.
Anjali Malhotra has over 20 years of experience in quality assurance and clinical laboratory testing. She currently works as a Quality Assurance Manager at LabCorp Clinical Trials, where she oversees quality objectives and compliance with regulations. Previously, she was a Quality Assurance Coordinator and Cytogenetics Supervisor at Quest Diagnostics, where she established quality management systems and automated processes. Malhotra holds an MBA in Health Care Administration and degrees in Medical Technology and Microbiology and Biochemistry. She maintains certifications in clinical cytogenetics, quality assurance, and Six Sigma.
G.CH. RAMA NAIDU has over 8 years of experience in analytical chemistry. He has worked at several pharmaceutical companies, including Pfizer, Apotex Research, and Aurobindo Research Centre. His areas of expertise include method validations, instrument qualifications, stability testing, and ensuring compliance. He is proficient in using instruments like HPLC, GC, UV, and IR. His responsibilities have included analytical method development and validation, instrument calibration, laboratory investigations, and providing training.
1. Benjamin R. Svoboda
21055th
Ave - Apt 705, Seattle,WA98121 (303) 746-9901 svo913@gmail.com
OBJECTIVE
My objective is to obtain a laboratory position supporting the testing, development, validation, transfer,
and automation of analytical methods in support of therapeutic drug development.
QUALIFICATION SUMMARY
I have over 10 years of experience in pharmaceutical Quality Control (QC) and Process and Product
Engineering (P&PE) laboratories assisting in the development, validation, transfer, and automation of
Bioassay and ELISA methods used to analyze In-Process, CIP, and Drug SubstanceProduct samples
under cGMP regulations.
During this time, I have achieved a technical knowledge of the performance and maintenance of cell-
based and immunochemistry assays, and an understanding of the drug development and
commercialization processes. I am comfortable with cell culture techniques, and the use of Ready-to-
Plate (RTP) cells in performing bioassays. Additionally, I have actively taken a leadership role in training
analysts across multiple Amgen sites, including Amgen Colorado (ACO), Amgen Rhode Island (ARI),
Amgen Puerto Rico (AML), and Amgen Dun Laoghaire (ADL).
Over the past 8 years, I have been automating bioassay and immunoassay methods using the Tecan
Freedom EVO automated liquid handling platform. In addition to implementing bioassay and
immunoassay automation at the Amgen Colorado (ACO) site, I have developed innovate techniques for
transferring scripts between Tecan robots within and across global laboratories.
I remain critical of the tasks I perform and continually seek to improve the quality of the science and
processes by which they are executed. I enjoy expanding my scientific knowledge and look forward to
continuing this pursuit in a development environment.
PROFESSIONALSKILLS
Bioassay (Cell-Based Assays)
Development, validation, transfer, and automation of proliferation, reporter gene, and AlphaLISA
methods for relative potency determination of active pharmaceutical ingredients (Amgen, Inc.)
Cell culture and use of Ready-to-Plate (RTP) cells in performing bioassays (Amgen, Inc.)
Assist in the maintenance and trending of assays and reagents
Leadership role in training analysts on bioassays at multiple Amgen sites (ACO, ARI, AML, ADL)
HTRF (Homogeneous Time Resolved Fluorescence)
Performance of HTRF method for relative potency determination of active pharmaceutical
ingredients (Amgen, Inc.).
2. BioELISA
Excellence in Operations Award (2012) for aid in developing, validating, and automating a
BioELISA for the detection of anti-IL-17 receptor monoclonal antibody, AMG 827 (Amgen, Inc.).
ELISA (Enzyme Linked Immunosorbent Assays)
Development, validation, transfer, and automation of ELISA methods for detection of active
pharmaceutical ingredients, impurities, and contaminants (Amgen, Inc., Lancaster Laboratories).
Development and performance of ELISA methods for meat speciation and allergen detection in
food products (ELISA Technologies).
Performance of ELISA method for detection of blood components during FDA 510(k) validation of
a novel medical device and protein purification kit for wound healing (COBE Cardiovascular).
LPLC (Low Pressure Liquid Chromatography)
Use of gel filtration (G200) and ion-exchange (DEAE, CM23) columns for purification of IgG for
use in ELISA methods (ELISA Technologies).
Laboratory Automation (Tecan Freedom EVO)
Script development, qualification, and performance of Bioassay and Immunoassay methods on
the Tecan Freedom EVO automated liquid handling platform using Freedom EVOware software
(Amgen, Inc.).
Leadership role in training analysts on Tecans at multiple Amgen sites (ACO, ARI, ADL)
Author of global SOP for qualification of Tecan automation in cGMP labs (Amgen, Inc.)
Innovative techniques for transferring scripts between Tecan robots within and across global
laboratories. (Amgen, Inc.)
cGMP (Current Good Manufacturing Practice)
Development, validation, transfer, and automation of analytical methods in a cGMP environment
for a major pharmaceutical company (Amgen, Inc., Lancaster Laboratories).
Laboratory Efficiency (LEAN Initiatives)
Creation and implementation of process boards in lab using six sigma methodology (Amgen, Inc).
Creation and implementation of kanban inventory system to organize requests and ordering of lab
reagents and materials (Amgen, Inc.).
Creation of controlled worksheets for calculation of assay dilutions and assay performance for
use with Tecan Freedom EVO platform (Amgen, Inc.).
EMPLOYMENTHISTORY
The DiLisi Group, Inc. Feb 2016 – Current
Quality Consultant
Consulting support for Amgen, Inc. (Thousand Oaks, CA).
Manage projects for creation of a global automation program across multiple network sites.
Automation of bioassay analytical methods using the Tecan Freedom EVO platform.
Training of Subject Matter Experts (SME) to support global automation program.
3. Amgen, Inc. – LongmontBoulder, CO Oct 2005 – May 2015
Specialist, Quality Control, QC (Jul 2012 – May 2015)
Performance, development, validation, and transfer of immunoassay and bioassay analytical
methods for Quality Control (QC) under current Good Manufacturing Practices (cGMP).
Automation of bioassay and immunoassay methods using the Tecan Freedom EVO platform.
Associate Scientist, Process and Product Engineering, P&PE (Jan 2010 – Jul 2012)
Performance and transfer of immunoassay and bioassay analytical methods in a development
laboratory responsible for method remediation.
Automation of immunoassay and bioassay analytical methods using the Tecan Freedom EVO
platform.
Implementation of monthly maintenance plan and guidance document for Tecan systems.
Senior Associate, Quality Control, QC (Oct 2005 – Dec 2009)
Performance, development, validation, and transfer of immunoassay and bioassay analytical
methods for Quality Control (QC) under current Good Manufacturing Practices (cGMP).
Automation of immunoassay analytical methods using the Tecan Freedom EVO platform.
Creation and implementation of kanban inventory system to organize requests and ordering of lab
reagents and materials.
Lancaster Laboratories – Longmont, CO Jun 2004 – Oct 2005
Lab Analyst (contracted to Amgen, Inc. in Longmont, CO)
Performance, validation, and transfer of analytical methods for Quality Control (QC) using cGMP.
COBE Cardiovascular – Arvada, CO Nov 2003 – Jun 2004
Laboratory Technician (contracted by Kelly Scientific Services)
Aided in testing and FDA 510(k) validation of a novel medical device and protein purification kit
for use in wound healing.
ELISA Technologies – Gainesville, FL Jan 2001 – Jul 2003
Laboratory Analyst, Production Supervisor
Performance, development and customer support for ELISA kits intended for meat speciation and
allergen detection in food products.
Production supervision of kits and components.
EDUCATION
B.S., Microbiology and Cell Science – May 2003
University of Florida – Gainesville, FL
PROFESSIONALREFERENCES
Available upon request.