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.
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.
Lisa P. Rudd has over 20 years of experience in scientific and medical fields. She has worked in pharmaceutical, biotech, and academic research laboratories, developing and validating analytical methods. She holds certifications in quality engineering, auditing, and project management. Rudd has expertise in cell culture, PCR, immunoassays, chromatography, mass spectrometry, and more. She has taught chemistry and provided tutoring. Currently, Rudd works as a caregiver while maintaining her scientific skills through contract work involving assay development, GC-MS testing, and paint formulation.
Monoclonal antibody (mAb) therapeutics have formed and continue to form the vast majority of biopharmaceutical company pipelines today with a number of remarkable commercial successes. The advent of mAbs as therapeutics has been greatly aided by a process platform approach that has enabled rapid development and manufacturing for this class of drugs.Downstream process platforms for mAbs first evolved over a decade ago and have had a significant impact on the time and resources spent in process development. This chapter describes some of the platform approaches first used in the biopharmaceutical industry and how those platforms have evolved over the last decade based on needs as well as newly available technology. We also describe the advent of next generation mAb based constructs and the creation of possible platforms for those moieties.
The document describes an optimized cell line development platform developed by Novartis. Key aspects include:
1) Implementation of a folic acid receptor selection system and enhanced CHO host cell line to increase productivity of cell pools and clones. This reduced development timelines by 5 months.
2) Evaluation of additional technologies like optimized UTRs/signal peptides and a "monoclonality checker" to further improve the platform.
3) Continuous optimization efforts including screening the CHO transcriptome, generating cell lines lacking problematic genomic regions, and evaluating new vector/selection marker combinations to maximize performance.
This document is a resume for Frank E. Inscore, who has over 10 years of experience as a senior chemist and R&D professional. He has expertise in analytical chemistry, organic synthesis, nanomaterials development, and laboratory management. Currently he works as an independent consultant providing analytical method development and validation services, with a focus on spectroscopy and nanocomposite materials.
Next Generation Recombinant Protein ManufacturingKBI Biopharma
Ìý
Next Generation Processes: What Model Works Best to Manufacture Recombinant Proteins in Asia?
BioPharma Asia 2017
Suntec Convention Center. Singapore, March 22, 2017
Thomas Jung, M.S. Vice President, Business Development
KBI Biopharma Inc.
Patrick Flanagan has over 15 years of experience in formulation development, analytical chemistry, and quality control. He currently works as a Principal Research Associate at Genzyme, a Sanofi company, where he supervises multiple employees and has hands-on experience in cGMP operations. Flanagan has led cross-functional teams, coordinated meetings and resources, and represented his department at internal and external conferences. He has extensive experience characterizing and developing formulations for various protein therapeutics.
The document summarizes the Genome in a Bottle Workshop held at NIST. It discusses the following:
- Four new GIAB reference materials (genomes) are being released for the PGP Human Genomes, including an AJ son, AJ trio, Asian son, and their parents.
- A microbial genome reference material is also being released containing genomic DNA from Salmonella Typhimurium, Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium sporogenes.
- The workshop will include working groups to discuss expanding variant characterization beyond easy variants, selecting future genomes, and experiences using existing reference materials. The goals are to advance reference materials, performance evaluation, and make biology
HIV Vaccines Process Development & Manufacturing - Pitfalls & PossibilitiesKBI Biopharma
Ìý
Originally presented at the HIV Vaccine Manufacturing Workshop –July 19th& 20th, 2017 by Abhinav A. Shukla, Ph.D.Senior Vice PresidentDevelopment & ManufacturingKBI Biopharma, Durham NC
This document discusses standards for characterizing whole genome sequencing. It describes the Genome in a Bottle Consortium which aims to develop reference materials, data, methods and performance metrics for whole genome variant calling. The consortium has characterized the genome of sample NA12878 and is working on Ashkenazim and Asian trios. The document outlines the need for standards and evidence regarding accurate and unbiased sequencing, sequence bioinformatics processing, and functional and clinical variant annotation in order to assess analytical and technical performance of whole genome sequencing for clinical use.
The document discusses the use of real-time in situ Fourier transform infrared spectroscopy (FTIR) for kinetic investigation of organic synthesis reactions using a ReactIR flow cell. It provides examples of using the flow cell to monitor a palladium-catalyzed cross-coupling reaction in both continuous flow and batch modes. Reaction progress kinetic analysis of the cross-coupling revealed it to be zero-order in both reactants and first-order in the palladium catalyst, indicating the rate-limiting step is likely reductive elimination.
This document discusses the Genome in a Bottle Consortium's efforts to develop reference materials and data to evaluate whole genome sequencing performance. It summarizes the release of new reference materials, including additional Genome in a Bottle samples from the Personal Genome Project and microbial genomic DNA standards. The consortium aims to apply principles of metrology to genome analysis by generating extensively characterized reference genomes and associated data that can be used to develop and validate analysis methods.
Adrian Joseph is seeking an entry-level scientist position in cell culture and biopharmaceutical purification. He has 5 years of lab research experience developing novel methods, including scale-down models to efficiently characterize harvest processes involving centrifugation, filtration, and other techniques. He completed internships developing such methods and presenting findings. Joseph holds a PhD focused on characterizing and scaling down mammalian cell culture harvest operations.
The document summarizes the Genome in a Bottle (GIAB) project, which aims to develop reference materials and benchmarks for evaluating human genome sequencing. GIAB has characterized 7 human genomes to high accuracy using multiple sequencing technologies and bioinformatics analyses. The characterized genomes and variant calls are made publicly available to benchmark sequencing performance. Recently, GIAB has incorporated linked and long read sequencing to expand reference benchmarks to more difficult genomic regions and develop benchmarks for structural variants.
An evaluation of methods used to sequence pGEM template within core facilitie...Laurence Dawkins-Hall
Ìý
A horizontal study by ABRF designed to investigate & collate cycle sequencing methods for the pGEM template and subsequent data output on automated sequencing platforms (cf. AB 3700 & AB 3100)
This document discusses the Genome in a Bottle Consortium's efforts to develop reference materials and standards to validate next generation sequencing assays. It provides an overview of the consortium's goals to generate reference genomes with highly confident variant calls and accompanying data to allow labs to compare results and assess false positives and false negatives. The document describes some examples of how labs are using the consortium's data on the NA12878 genome to benchmark sequencing platforms and bioinformatics workflows.
Clayton E. Carey is a recent graduate seeking a career in the biopharmaceutical industry. He received a Bachelor of Science in Chemical and Biomolecular Engineering from North Carolina State University with a minor in Bio-Manufacturing. His coursework covered topics like drug development, bioseparations, downstream processing, cell culture techniques, and biochemical engineering. For his research, he modeled morphogen gradients in fruit fly embryos and improved ethanol production in Clostridium Thermocellum through gene knockout and directed evolution. He was involved in various student organizations and received academic scholarships.
Eric Greco has over 5 years of experience in organic synthesis, spectroscopy, chromatography, and method development. He currently works as an Applications Scientist at Crodain conducting analytical research, method development, and characterization of compounds. Previously he has held positions as a Production Chemist, Research Assistant, Quality Control Intern, and EHS Intern where he gained experience in wet chemistry techniques, spectroscopy, method development, and adhering to cGMP and safety standards. He has a Bachelor of Science in Chemistry from Temple University.
This document provides an overview of connectivity between chemistry, biology, and published documents. It discusses the challenges of extracting this information ("D-A-R-C-P") from publications and patents. While some commercial and open-source efforts curate this data, most of it remains buried in documents. Automated extraction has limitations compared to expert curation. The document argues that authors should directly connect their results to databases to improve flow of information.
Presentation at BPI West by Abhinav A. Shukla, Ph.D. Senior Vice President Development & Manufacturing KBI Biopharma, Durham NC, February 27 – March 2, 2017, Platforms for mAb Commercialization
Microbion offers analytical, research and development, and bio-bank services for nutraceutical companies. Their services include genomic analysis of microorganisms used in probiotics and fermented foods, as well as assessing genetic stability, purity, safety, and validating health claims. Microbion can also authenticate strains using DNA fingerprinting and develop diagnostic methods and protocols tailored for specific customer strains or formulations.
This document is a CV for Mariano Ertoft, a passionate laboratory technician with over 25 years of experience in areas such as RNA/DNA work, cloning, cell analysis, clinical trials, diagnostics samples, and cell line growth. Some of their major accomplishments include developing adjuvants that were tested in clinical trials and an analysis to inactivate orthopox viruses. They have worked in various roles for organizations such as Statens Serum Institut, Dandiag A/S, and Unizyme Laboratories A/S developing skills in techniques like ELISA, FACS, PCR, and sequencing.
Eric Walters has over 20 years of experience in protein science and analytical development. He has extensive experience developing and optimizing HPLC, mass spectrometry, and other analytical methods to characterize and quality proteins such as monoclonal antibodies. Some of his skills include protein purification, enzyme and antibody assay development, method validation and qualification, and experience working in research and cGMP environments.
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.
This document contains the resume of Dinesh Kumar who is applying for positions as a diagnostic specialist or senior lab technician involving flow cytometry and cancer research. He has a BSc in pathology and over 5 years of experience working with flow cytometry equipment like BD FACSCanto II at clinical laboratories. His responsibilities involved processing, acquiring, analyzing and validating samples for conditions like leukemia, CD markers, stem cell enumeration, and DNA ploidy. He is proficient in operating, maintaining and troubleshooting flow cytometers and designing multi-color experiments.
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.
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.
Maha W. Rizk is a senior-level researcher with over 10 years of experience in biotechnology and pharmaceuticals. She has expertise in oncology, inflammation, and neurological biomarkers as well as experience in drug discovery, preclinical studies, and clinical trials. Her technical skills include developing and validating cell-based assays, protein analysis, DNA/RNA extraction, and data analysis software. She currently works as a senior associate scientist at Amgen performing assays for oncology, inflammation, and neuroscience drug candidates.
Patrick Flanagan has over 15 years of experience in formulation development, analytical chemistry, and quality control. He currently works as a Principal Research Associate at Genzyme, a Sanofi company, where he supervises multiple employees and has hands-on experience in cGMP operations. Flanagan has led cross-functional teams, coordinated meetings and resources, and represented his department at internal and external conferences. He has extensive experience characterizing and developing formulations for various protein therapeutics.
The document summarizes the Genome in a Bottle Workshop held at NIST. It discusses the following:
- Four new GIAB reference materials (genomes) are being released for the PGP Human Genomes, including an AJ son, AJ trio, Asian son, and their parents.
- A microbial genome reference material is also being released containing genomic DNA from Salmonella Typhimurium, Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium sporogenes.
- The workshop will include working groups to discuss expanding variant characterization beyond easy variants, selecting future genomes, and experiences using existing reference materials. The goals are to advance reference materials, performance evaluation, and make biology
HIV Vaccines Process Development & Manufacturing - Pitfalls & PossibilitiesKBI Biopharma
Ìý
Originally presented at the HIV Vaccine Manufacturing Workshop –July 19th& 20th, 2017 by Abhinav A. Shukla, Ph.D.Senior Vice PresidentDevelopment & ManufacturingKBI Biopharma, Durham NC
This document discusses standards for characterizing whole genome sequencing. It describes the Genome in a Bottle Consortium which aims to develop reference materials, data, methods and performance metrics for whole genome variant calling. The consortium has characterized the genome of sample NA12878 and is working on Ashkenazim and Asian trios. The document outlines the need for standards and evidence regarding accurate and unbiased sequencing, sequence bioinformatics processing, and functional and clinical variant annotation in order to assess analytical and technical performance of whole genome sequencing for clinical use.
The document discusses the use of real-time in situ Fourier transform infrared spectroscopy (FTIR) for kinetic investigation of organic synthesis reactions using a ReactIR flow cell. It provides examples of using the flow cell to monitor a palladium-catalyzed cross-coupling reaction in both continuous flow and batch modes. Reaction progress kinetic analysis of the cross-coupling revealed it to be zero-order in both reactants and first-order in the palladium catalyst, indicating the rate-limiting step is likely reductive elimination.
This document discusses the Genome in a Bottle Consortium's efforts to develop reference materials and data to evaluate whole genome sequencing performance. It summarizes the release of new reference materials, including additional Genome in a Bottle samples from the Personal Genome Project and microbial genomic DNA standards. The consortium aims to apply principles of metrology to genome analysis by generating extensively characterized reference genomes and associated data that can be used to develop and validate analysis methods.
Adrian Joseph is seeking an entry-level scientist position in cell culture and biopharmaceutical purification. He has 5 years of lab research experience developing novel methods, including scale-down models to efficiently characterize harvest processes involving centrifugation, filtration, and other techniques. He completed internships developing such methods and presenting findings. Joseph holds a PhD focused on characterizing and scaling down mammalian cell culture harvest operations.
The document summarizes the Genome in a Bottle (GIAB) project, which aims to develop reference materials and benchmarks for evaluating human genome sequencing. GIAB has characterized 7 human genomes to high accuracy using multiple sequencing technologies and bioinformatics analyses. The characterized genomes and variant calls are made publicly available to benchmark sequencing performance. Recently, GIAB has incorporated linked and long read sequencing to expand reference benchmarks to more difficult genomic regions and develop benchmarks for structural variants.
An evaluation of methods used to sequence pGEM template within core facilitie...Laurence Dawkins-Hall
Ìý
A horizontal study by ABRF designed to investigate & collate cycle sequencing methods for the pGEM template and subsequent data output on automated sequencing platforms (cf. AB 3700 & AB 3100)
This document discusses the Genome in a Bottle Consortium's efforts to develop reference materials and standards to validate next generation sequencing assays. It provides an overview of the consortium's goals to generate reference genomes with highly confident variant calls and accompanying data to allow labs to compare results and assess false positives and false negatives. The document describes some examples of how labs are using the consortium's data on the NA12878 genome to benchmark sequencing platforms and bioinformatics workflows.
Clayton E. Carey is a recent graduate seeking a career in the biopharmaceutical industry. He received a Bachelor of Science in Chemical and Biomolecular Engineering from North Carolina State University with a minor in Bio-Manufacturing. His coursework covered topics like drug development, bioseparations, downstream processing, cell culture techniques, and biochemical engineering. For his research, he modeled morphogen gradients in fruit fly embryos and improved ethanol production in Clostridium Thermocellum through gene knockout and directed evolution. He was involved in various student organizations and received academic scholarships.
Eric Greco has over 5 years of experience in organic synthesis, spectroscopy, chromatography, and method development. He currently works as an Applications Scientist at Crodain conducting analytical research, method development, and characterization of compounds. Previously he has held positions as a Production Chemist, Research Assistant, Quality Control Intern, and EHS Intern where he gained experience in wet chemistry techniques, spectroscopy, method development, and adhering to cGMP and safety standards. He has a Bachelor of Science in Chemistry from Temple University.
This document provides an overview of connectivity between chemistry, biology, and published documents. It discusses the challenges of extracting this information ("D-A-R-C-P") from publications and patents. While some commercial and open-source efforts curate this data, most of it remains buried in documents. Automated extraction has limitations compared to expert curation. The document argues that authors should directly connect their results to databases to improve flow of information.
Presentation at BPI West by Abhinav A. Shukla, Ph.D. Senior Vice President Development & Manufacturing KBI Biopharma, Durham NC, February 27 – March 2, 2017, Platforms for mAb Commercialization
Microbion offers analytical, research and development, and bio-bank services for nutraceutical companies. Their services include genomic analysis of microorganisms used in probiotics and fermented foods, as well as assessing genetic stability, purity, safety, and validating health claims. Microbion can also authenticate strains using DNA fingerprinting and develop diagnostic methods and protocols tailored for specific customer strains or formulations.
This document is a CV for Mariano Ertoft, a passionate laboratory technician with over 25 years of experience in areas such as RNA/DNA work, cloning, cell analysis, clinical trials, diagnostics samples, and cell line growth. Some of their major accomplishments include developing adjuvants that were tested in clinical trials and an analysis to inactivate orthopox viruses. They have worked in various roles for organizations such as Statens Serum Institut, Dandiag A/S, and Unizyme Laboratories A/S developing skills in techniques like ELISA, FACS, PCR, and sequencing.
Eric Walters has over 20 years of experience in protein science and analytical development. He has extensive experience developing and optimizing HPLC, mass spectrometry, and other analytical methods to characterize and quality proteins such as monoclonal antibodies. Some of his skills include protein purification, enzyme and antibody assay development, method validation and qualification, and experience working in research and cGMP environments.
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.
This document contains the resume of Dinesh Kumar who is applying for positions as a diagnostic specialist or senior lab technician involving flow cytometry and cancer research. He has a BSc in pathology and over 5 years of experience working with flow cytometry equipment like BD FACSCanto II at clinical laboratories. His responsibilities involved processing, acquiring, analyzing and validating samples for conditions like leukemia, CD markers, stem cell enumeration, and DNA ploidy. He is proficient in operating, maintaining and troubleshooting flow cytometers and designing multi-color experiments.
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.
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.
Maha W. Rizk is a senior-level researcher with over 10 years of experience in biotechnology and pharmaceuticals. She has expertise in oncology, inflammation, and neurological biomarkers as well as experience in drug discovery, preclinical studies, and clinical trials. Her technical skills include developing and validating cell-based assays, protein analysis, DNA/RNA extraction, and data analysis software. She currently works as a senior associate scientist at Amgen performing assays for oncology, inflammation, and neuroscience drug candidates.
Steven Chico has over 15 years of experience in analytical science and materials science. He has worked at several major pharmaceutical companies, including Merck, Regeneron, Pfizer, and Sigma Aldrich. His experience includes developing and validating analytical methods, characterizing proteins and formulations, leading projects, and ensuring compliance with GMP and GLP regulations. He has authored publications and received awards for his contributions to green chemistry and individual performance.
Current CV .
My objective is to obtain a rewarding and challenging research scientist position where my background and experience will contribute to the success of a growing company or research center.
Currently, I am a Senior Associate Scientist at Amgen Inc. and certified Molecular Biologist with the American Society of Clinical Pathology MB (ASCP). I have more than 10 years of experience in the biotechnology/ pharmaceutical industry. I am highly proficient in various lab techniques, technologies, and automation. I demonstrated consistent success in the execution of assay development and method validation activities supporting clinical stage programs within GCP and GLP regulated environments. I possess extensive experience in optimization and validation of drug potency assays (ELISA and cell based assays), protein purification and characterization, and DNA/RNA extraction and quantitation. I am a subject matter expertise in the areas of human and rodent cell lines propagation and tissue dis-aggregation. I have proven operational capabilities in the establishment of standard operating procedures to ensure our laboratory meets regulatory and business requirements.
I am a self-motivated professional who works effectively as an individual contributor or within a team matrix. As a quick learner, I can efficiently deliver results, easily adapt to changing environment and provide fresh ideas. My strengths include statistical analysis/guidance, report writing, and communication.
Thank you in advance for your consideration. Please feel free to call me at (805-990-6258), or by e-mail at (mahawally46@gmail.com) if you have questions or would like a list of references.
Sincerely,
Maha Rizk
Derek D. Poore is an accomplished scientist with extensive experience in molecular and cellular biology, drug discovery, and assay development. He has over 10 years of experience developing cellular and biochemical assays at GlaxoSmithKline. He is skilled in various screening platforms and assay technologies and is an effective communicator and collaborative team player.
1) The document describes the development of a fully automated purification platform using preparative liquid chromatography/mass spectrometry (LC/MS) to streamline the process of purifying crude synthetic compounds from receipt to biochemical screening.
2) The platform includes six integrated workstations controlled by a central program to automatically dissolve, analyze, purify, collect fractions, weigh, and distribute compounds for assay and quality control.
3) The program was designed to minimize errors, automatically select purification methods, generate purification sequences, and track samples and data from start to finish to decrease the time required to get compounds into screening.
Marcy Hibshman has over 10 years of experience as a Principal Microbiologist, specializing in endotoxin and sterility testing for the pharmaceutical industry. She oversees testing, manages personnel, writes reports and standard operating procedures, and improves efficiency through process optimization. She is proficient in aseptic technique, GMP/GLP compliance, and technical problem-solving.
Wendy Cladman has over 25 years of experience as a laboratory professional with expertise in experimental design, execution of protocols, and laboratory management. She has extensive experience across multiple disciplines including biology, biochemistry, pharmacology, and molecular biology. Some of her key skills include assay development, protein purification techniques, molecular biology techniques, data analysis, and training and supervision of personnel. She has authored 9 peer-reviewed publications and has worked in academic and industry laboratory settings.
SJA CV Training Certificates and Work Presentation 15-Apr-18Shareef Jarvi Antar
Ìý
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.
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.
Ryan McLay seeks a position as a Chemical Engineer, highlighting his experience in material characterization, catalyst development, pharmaceutical analysis, and biochemical processes. He holds an MS in Chemical Engineering from the University of Houston and a BS in Chemical Engineering from Florida Institute of Technology, with a minor in Nanotechnology. His technical skills include instrumentation like SEM, TEM, and chromatography. As a research scientist, he engineered bacterial strains and increased their chemotaxis and biofouling properties. As an intern, he designed homogeneous catalysts and studied catalyst decomposition pathways. He also has coursework in areas like separation processes, chemical reactor design, and materials engineering.
Jihad Missaoui has a Bachelor of Science degree in Biology from Salem State University. He has laboratory experience in protein purification, PCR, chromatography, microscopy, and other techniques. His work experience includes quality control and laboratory roles at Millipore EMD and Phigenics, where he prepared media/buffers, performed assays and analyses, maintained documentation, and ensured compliance. He also has experience as a research assistant in Morocco collecting and analyzing water samples to determine microorganism presence and water quality.
1) The co-op student worked at Bristol-Myers Squibb to optimize protein purification chromatography conditions and improve impurity clearance.
2) High-throughput screening was used to evaluate different buffer and resin combinations. Process conditions were optimized to separate variants and improve purity.
3) The student met project goals including developing chromatography methods, characterizing protein populations, and providing insights into improving processes. The work focused on optimizing the initial protein A capture step to reduce downstream purification needs.
Daniel K. Lesniewski has over 15 years of experience in organic synthesis, analytical chemistry, and process development. He holds an M.Sc. in Organic Chemistry from Colorado State University-Pueblo and a B.Sc. in Chemistry from the same institution. His experience includes positions at Corden Pharma, Avista Pharma Solutions, General Air, Amgen, Lexmark International, and Colorado State University, where he has experience in multi-step organic synthesis, analytical instrumentation, scale-up reactions, method development, and research.
Kenneth M. Straub has over 15 years of experience as a senior scientist specializing in applications of mass spectrometry to protein and peptide analytics. He has extensive experience characterizing recombinant proteins and peptides using advanced mass spectrometry technologies and is well-versed in bioinformatics and high throughput techniques. Currently employed at Roche Palo Alto, LLC, he provides analytical support to project teams and operates under GMP/GXP regulations, supervising Ph.D. and MS/BS level staff.
The document discusses developing curriculum to support careers in biomanufacturing and the bioeconomy. It proposes hands-on workshops for teachers and students to learn biomanufacturing concepts and techniques. These include transforming bacteria, purifying proteins through various types of chromatography, and analyzing purified proteins through electrophoresis. The goal is to promote STEM education and careers in the growing biomanufacturing industry.
1. Raymond P Damien
rpdamien@gmail.com
30 Glen Ave
Fitchburg, MA 01420
mobile: (978) 790-7742
Continued
SUMMARYOF EXPERIENCE
ï‚· HPLC/UPLC (Reverse Phase,SPE,GPC)
ï‚· Flash Column Chromatography (Purification)
ï‚· TLC (Thin Layer Chromatography)
ï‚· UV-Vis, Florescence (Florescamine), BCA,Micro BCA
ï‚· Gel and Capillary Electrophoresis
ï‚· DLS (Dynamic Light Scattering)
ï‚· Equilibrium Dialysis
ï‚· Cell line culture and maintenance
ï‚· Method Development, and Validation
ï‚· DoE (Design of Experiments)
ï‚· In vitro Release Studies and Data Interpretation
ï‚· Biologic and Drug Substance Encapsulation and Formulation
ï‚· Rheology
ï‚· Gel and Capillary Electrophoresis (SDS-PAGE and Agarose)
ï‚· DNA Extraction and PCR
ï‚· cGMP/GLP/GXP Environments
ï‚· Automation and System Integration
ï‚· SOP and Development Report writing
ï‚· Trained in MA RCRA and DOT hazardous materials and chemical hygiene requirements
EXPERIENCE
Selecta
Biosciences
Research Associate
Analytical Development
Watertown, MA,
July 2011 – February 2016
ï‚· Developed and improved sample preparation and analysis methods of complex Synthetic Vaccine
Particle components (Peptides and Proteins) by HPLC
ï‚· Developed and improved sample preparation and analysis methods of single strand synthetic DNA
(CpG) encapsulated nanoparticles by HPLC
ï‚· Experienced with using gradient reversed-phase separations,creation of HPLC methods, preparations
of mobile phases, and (Agilent 1100, 1260, and 1290 with Chemstation) HPLC maintenance
ï‚· Used DLS (Dynamic Light Scattering) to determine particle size and polydispersity
ï‚· Determined molecular weight by GPC (Gel Permeation Chromatography)
ï‚· Protein analysis by SDS-PAGE and antibody binding affinity through Equilibrium Dialysis
ï‚· Wrote SOP's and Reports to document test methods, procedures, OOT/OOS results, and technical
documents
ï‚· Trained in MA DOT regulations of 49 CFR 100-185, MA RCRA,and member of the Safety
Committee
ï‚· Served as analytical representative for 2 project teams
Ocular Therapeutix
(I-Therapeutix)
Research Associate
Research and Development/ Drug Delivery
Bedford, MA,
April 2008 – September 2010
ï‚· Developed methods of encapsulating drugs to be delivered Zero Order using biocompatible polymers
ï‚· Built MS Access database used to control chemical inventory, and synchronized it with electronic
versions of all MSDS sheets
ï‚· Provided initial preclinical work that changed company focus from stand-alone medical devices to
incorporate drug delivery
ï‚· Designed and developed hydrogel-based products using novel polymers and cross-linking
technologies
ï‚· Provided technical documents detailing the design and analysis to support design control
2. Raymond P Damien
rpdamien@gmail.com
Continued
ï‚· Developed correlational In Vivo/In Vitro studies to document efficacy of drug candidates and
determined the necessary response outputs
ï‚· Coordinated removal of lab waste per OSHA/DOT requirements and, trained and certified for 49 CFR
172 Subpart H
Xcellerex Research Associate
Process Development
Marlborough, MA,
September 2007 – April 2008
ï‚· Performed High Throughput Design of Experiments to design both Basal Growth Media and Feed
Media for a CHO cell line
ï‚· Cultured and maintained cell lines
ï‚· Automated methods for conducting a Design of Experiments (DOE) using robots from Tecan and
Caliper
ï‚· Developed robotic Hit Picking methods for the selection of clones
ï‚· Assisted in the development of a mini bioreactor
ï‚· Integrated multiple robots to reduce the need for constant human interface in GMP environments
Caliper Life
Sciences
Senior Product Test Scientist
Research and Development
Hopkinton, MA,
December 2006 – July 2007
ï‚· Developed qualification documents, IQ, OQ,and PQ for a robotic liquid handling system (Sciclone
ALH 3000, Affymetrix Genechip Array Station, and Zephyr) and a capillary electrophoresis system
(Lab Chip 90)
ï‚· Worked closely with R&D and Manufacturing to develop and troubleshoot new hardware and
software
ï‚· Provided expertise to assist in applications development, and technical support
ï‚· Developed test plans to document crucial changes necessary to successfully launch a product
ï‚· Performed statistical analyses regarding product reliability
ï‚· Researched and prepared a technical report on a high volume head with all associated arrays for a robotic
liquid handler
ï‚· Developed methods using UV-VIS detection and Fluorescence to determine a robotic liquid handler's
ability to perform serial dilutions
ï‚· Researched methods to effectively automate PCR of Affymetrix's Genome-Wide Human SNP
Anika
Therapeutics
Research Associate
Research and Development
Woburn,MA,
April 2004 – October 2006
ï‚· Performed purifications through Flash column chromatography
ï‚· Analyzed purity and concentration using HPLC (gradient and isocratic methods)
ï‚· Performed Design-of Experiments (DOE) on both the synthesis and purification of a novel cross
linker
ï‚· Experienced in using rheology to determine viscosity and enzymatic degradation of viscoelastic gels
ï‚· Performed TLC to determine proper specs for UV absorbance and detection criteria.
ï‚· Developed proper mobile phase components for chromatographic purification
ï‚· Developed Batch Records and Manufacturing Directions for multiple development products and
prepared technical reports based on original research and data
ï‚· Initiated and performed screening studies for the use of antioxidants in a formulation
ï‚· Developed and performed accelerated stability studies to determine the longevity of a product
Avecia
Biotechnology
QC Technician (Contract)
Quality Control
Milford, MA,
January 2004 – February 2004
ï‚· Responsible for gathering data on TOC and Conductivity for the qualification of a purified water
system according to cGMP and USP guidelines, and organizing data for qualification and validation
AstraZeneca Research Assistant
Cancer Bioscience R&D
Waltham, MA,
March 2002 - November 2002
ï‚· Performed DNA Sequencing by Capillary Electrophoresis
ï‚· Analyzed and reported sequencing data (contig alignments and description of any mutations)
3. Raymond P Damien
rpdamien@gmail.com
ï‚· Performed transforming of chemically competent cells for TOPO insertion cloning
ï‚· Performed PCR to amplify and ligate DNA and its specific primer
ï‚· Extracted DNA from cultures via spin column methods (Qiagen Mini Prep and Maxi Prep)
ï‚· Performed sub-cloning for site-directed mutagenesis reactions
Millennium
Pharmaceuticals
Research Assistant
Sequencing QA/QC
Cambridge, MA,
June 1999 – February 2000
ï‚· Performed DNA extraction via vacuum manifold methods
ï‚· Performed DNA Sequencing by gel and capillary electrophoresis
ï‚· Worked with robotic liquid handling devices (Tecan Genesis and a custom build from Cyberlab)
ï‚· Performed Single Stranded DNA reactions using the M13 bacteriophage, and Double Stranded
Reactions on plasmid DNA
 Designed Excel Macros for detailing raw data,and developd SOP’s for Documentation Control
EDUCATION
American International College
Springfield, MA
ï‚· Bachelors of Science degree in Biology, and Chemistry
 Awarded May 1999; Honors: GPA 3.3, Dean’s list, United Paper Worker’s Scholarship
COMPUTER SKILLS
UNIX Sequencher
Microsoft Office Suite Photoshop
DNA Star Maestro
Mantis Bug Tracker Merant Tracker
MS SQL iLink Pro
PDM Works Quick Test Professional
Visio Oracle
Agilent Chemstation Minitab
Waters Empower Shimadzu
OTHER
ï‚· Vice President of Operations for the Central Mass Cycling Club
ï‚· Fluent in French/Canadian French