| Candidate Information | | Title | Process Engineer Document Control | | Target Location | US-NC-Charlotte |
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Click here or scroll down to respond to this candidateSUMMARYExperienced in ISO9001 manufacturing, bench to clinical phase & cGMP, GLP research and manufacturing, including cell line development & cell culture using Human placenta, Tumor cells, CHO, HEK and NS0, plus yeast, E-Coli and Streptococcus bacterial fermentation in benchtop to large scale re-usable or disposable Single Use equipment (SUB). Handling human blood samples for DNA isolation, digest and building libraries. Performed Upstream and downstream technical transfer of virus, protein and biopolymers products.Skilled in process scale up, tech transfer, automated process controls, analytical methodologies, aseptic process (sterile fill/finish), equipment management, trouble shooting, design/ fabrication, team development / management, document control systems, SOP authoring, IQ, OQ and PQ, Deviation Investigation and CAPA management.PROFESSIONAL EXPERIENCEPfizer Rocky Mount, NC Jul2024-PresentProcess Engineer (Contract Position)cGMP Manufacturing Final Formulation and Fill operations. Performing Tech Transfer for products already in the marketPrimary activities include participating in the final formulation activities in a new facility to ensure the products manufactured in the new facility will have identical potency and stability specifications as those manufactured in the older facility. Authoring tech transfer documents, collecting samples and building a study model to establish a successful tech transfer.ABZENA San Diego, CA May2022-Jan2024Senior MSAT Senior EngineerDesign bioreactor plumbing and air handling system.cGMP Manufacturing Cell Culture in Single Use Bioreactors (SUBs) up to 2000L capacity. Performing support for cell culture and harvest capture for multiple products including product changeover activities using all single use technology, including component assembly and design.Performed document authoring, annual reviews, creating BOM documents, deviation investigation and CAPA management. Employed MFCS automation and TrackwisePerformed Fill equipment commissioning, aseptic fill qualification, and validation of filling activities of time and temperature sensitive intermediates and sterile final finish and packaging for drug products.Purchase New equipment to improve operation safety, write URSs, IQ, PQ, OQ, WIs and SOPs for the manufacturing team and perform all required training.Monitor analytical equipment for performance, update software and maintain relative Work Instructions and SOPs for accuracy and robustness.Conducted training and acted as SME solving process or equipment issues for the upstream team.Participated in area 5S to improve efficient manufacturing floor usage.Evaluated flow through single use centrifuges for clarified harvest material.Assisted in solving Safety issues by ordering and setting up of safe equipment for use on the floor.AGC Biologics Bothell, WA Jan 2021-Apr-2022Upstream Manufacturing SupervisorManaged cGMP Manufacturing Cell Culture in SS bioreactors and Single Use Bioreactors up to 3000L capacity in multiple facilities performing cell culture through harvest capture for multiple products.Performed internal walkthrough audits for product changeover, for manufacturing readiness and in preparation for FDA visits.Performed deviation investigation and CAPA management.Participated in hiring and managing the facilities. Supervised up to 9 associates.Employed Delta-V automation, LIMS and Trackwise.Evaluated single use Sartorius Flow through centrifuge for harvest capture.Abbott Carlsbad, CA Jun 2020-Jan-2021Upstream Manufacturing Scientist (Contract Position)Designed required plumbing for bioreactor CIP and SIP lines yielding fail safe clean and sterile bioreactors.cGMP Manufacturing & process development.Performed PQ and OQ of 100L Stainless Steel fermenters, devised CIP/SIP procedures and validated results.Performed bacterial fermentation in 10, 40 and 100L batches in support of making an effective Covid-19 test kit using MFCS automation.Adverum Biotechnologies. Redwood City, CA Jan 2020-Jun2020Manufacturing and Process Development Associate III, Cell CultureParticipated in manufacturing, process development and quality teams in a cGMP process.Performed fed batch cell culture in 50 and 200L Single Use Bioreactors and equipment producing AAV based viral vectors for gene therapy using MFCS automation.Revised manufacturing documents, helping to re-establish manufacturing facility in a new location.Lead, author documents, Equipment IQ to start cGMP manufacturing of new AAV product line.Tocagen Inc. San Diego, CA May2015-Dec 2019Development Associate III,Cell Culture & Purification DevelopmentPerformed perfusion cell culture, developed process improvements using microscopy, 5L bioreactors & 50L Single Use Bioreactors for suspension cultures and 10-layer cell-stack for adherent cell cultures resulting in vector production in support of gene therapy for brain cancer.Brainstormed, conducted media development experiments using DOE and JMP, formulated cell culture media from raw ingredients, tested productivity improved medium used for cGMP manufacturing.Tested each improved media with various cell lines to evaluate cell growth and productivity using MFCS automation and verified harvested quality post purification.Developed purification strategies using column chromatography, Unicorn automation and AKTA, testing various resin types and schemes using JMP. Some resins resulted in effective vector yields.Developed downstream strategies using TFF, Hollow fiber UF/DF operations maximizing product yield.Using DOE, performed experiments comparing Hollow fiber and Cassette UF/DF membranes in designing new purification strategies.Analyzed results by protein assays, SDS PAGE, cell-based titer assay by means of vector quantitative qPCR verifying process improvements for purity and yield.Supported cGMP manufacturing by testing samples from both process development and manufacturing operations to insure successful tech transfer, Audited documents in preparation for FDA visits.Designed a cold labeling machine for product vials to minimize temperature excursion in final product.Avid Bio services, Tustin, CA Jul 2011- Jan 2014Process Engineer, Manufacturing Science and Technology (MSAT)Performed drug development, product development and tech transfer using CHO and HEK cell lines from bench into 1000L Single Use Bioreactors in the cGMP manufacturing facility using MFCS software.Authored SOPs, trained operators performing manufacturing operations, overseeing engineering runs. Revised and updated final SOPs as required.Performed internal audits in preparation for FDA visits, deviation investigations, 5m and fishbone guidelines for root cause analysis/ closures and CAPA management.On an AIDS vaccine manufacturing, optimized purification by performing, MF, UF/DF. column chromatography purification using DOE and Minitab. Demonstrated improvements in pilot scale runs, authored downstream purification process.Validated the process by performing Blue Native PAGE, SDS PAGE gels and western blots.Drafted URSs for Vi-Cell Analyzers, assisted in validation of new equipment, wrote applicable manufacturing SOPs and trained operators on all new equipment.Biogen IDEC.Associate Scientist II, San Diego, CA May 2007 - Jun 2011Performed pilot scale cell culture development scientist leading to fail- safe cultures.Designed bioreactor setup, plumbing, air handling and CIP/ SIP for fail safe bioreactors.Performed tech transfer of newly developed processes to large scale manufacturing, resulting in production processes that maintained cell growth from pilot scale to large scale manufacturing.Using Wave, Single Use and SS bioreactors from 5L up to 400 L utilizing MFCS automation.Developed projects from small scale to manufacturing with high growth rate and titer results.Led IQ, OQ for new process equipment and analytical and process equipment.Performed DOE experiments: temperature, agitation, oxygen and glucose consumption rates to increase productivity and to define ideal culture parameters.Prevented contaminations in cell culture batches by planning regular PM on critical equipment and closely monitoring sterilization processes avoiding cold spots and dead legs.Performed formulation of final drug product, Solubility, buffer robustness, freeze/thaw, color, dilution stability, deamidation, and long-term stability studies for a large molecule protein product.Analyzed protein stability using Waters HPLC, SEC, UV Spectrophotometer, DSC, and Hunter lab Color Quest to investigate protein stability when subjected to test environment.Performed final formulation, fill and packaging for products in advance of NDA submission.Biogen IDEC. Cambridge, MAManufacturing Associate IV, (May 2006- May 2007)Cell culture cGMP manufacturing group (2000L):Utilized Delta-V operating system in a cGMP cell culture manufacturing facility.Revised/ updated manufacturing documents and procedures as required.Developed new method to calculate accurate weight and volumes in process vessels resulting tight weight tolerances which reduced deviations and allowed for an improved process control.Cambrex Biosciences, Hopkinton, MA Aug 2004-May 2006Process Development Associate,Using DOE strategies and Unicorn Automation performed and validated 15L pilot scale fed-batch yeast fermentations of Pichia Pastoris producing recombinant Botulism vaccine.Tested growth parameters to find ideal fermentation criteria.Improved fermentation process using JMP, monitored mixing and oxygen usage.Performed harvest capture using flow through centrifuges.Used TRACKWISE PLC and DCS investigating and documenting deviation issues.Process evaluation, equipment commissioning providing 24-hour monitoring of productions.Revised and authored new SOPs manufacturing a botulism vaccine.Genzyme Corporation, Allston MASenior Manufacturing Associate, Aug 1996 - Apr 2004Participated in production of large/small scale, sterile buffers and purified protein products using a Rosemont and Delta V automation systems and a variety of column types.Researched, purchased and brought key equipment such as CIP/SIP, MF, UF/DF, and a variety of chromatography columns in cGMP manufacturing.Assisted in large scale Perfusion Cell Culture 2000L bioreactors using microcarriers.Assisted with Product Development Tech Transfer and Validation of processes.Authored manufacturing SOPs, Performed deviation investigations and supervised operators.Performed in cross functional teams, for failure investigations and product contaminations.Genzyme Corporation, Cambridge MAManufacturing Associate, Fermentation and Purification Sep 1989 - Aug 1996Supervised four employees, scheduling, mentoring, and performed manufacturing activities.Biologics drug development, surgical implant development, CIP/SIP, component prep, media prep, 3L - 180L fermentation, UF/DF, purification, aseptic processing, lyophilization, sterile fill and finish.Aseptic packaging of drug products, media, dry powder, dry film implants, gels and burn cream.Assisted in research for production of multiple biopolymer products and enzymes.Performed cell line development, monitored production runs and collaborated with cross- functional teams to improve production.Proposed creative, effective improvements and introduced new technologies increasing efficiency.Designed equipment and fermenters to perform CIP and SIP operations. Aided in fabrication and assisted in validation of new production processes specific for highly viscous materials.Applied sound mixing strategies to maintain best culture viability and productivity.Improved activities and procedures resulting in fail-safe fermentation and purification runs.Investigated process variations, Performed deviation investigations. proposed corrective actions.Participated in development to market of Fabrazyme, Synvisc, Hal-C and Hal-S products. Provided high density Hyaluronic Acid products for eye surgery sold by Alcon, and low density for implants.Massachusetts General Hospital, Boston, MA Jun 1988 - Sep 1989Research Associate, Molecular BiologyResearched heredity pattern of Multiple Sclerosis by evaluating blood samples from MS patients & blood relatives.Purified blood DNA, building DNA libraries, performing digests, Southern Blots, and analyzing data. Helped publishing reports that proved heredity factors of Multiple Sclerosis.Genzyme Corporation, Boston, MA Jun 1986 - Jun 1988Manufacturing Technician, Protein PurificationExtracted, concentrated and purified protein products from human placenta in support of clinical studies using manual extraction, dialysis and purification techniques.Employed flow through centrifuges for product capture.Performed mini/bulk preps; collected plasmids, HEK cells for recombinant proteins cell culture.Performed cell line selection to initiate cell culture resulting in building a new manufacturing facility in Allston, MA. To manufacture Genzymes product Cerezyme.EDUCATIONB.A. (Biology) Sept 1976 - June 1980 Boston University - Boston, MAAwardsTwice recipient of VP award Genzyme corp. - Cambridge, MAThree times achievement awards Genzyme corp. - Cambridge, MAAchievement awards Adverum - Redwood City, CA |
