Process Engineer Document Control

SUMMARY

●Experienced in ISO**** manufacturing, bench to clinical phase & cGMP, GLP research and manufacturing, cell line development & cell culture using Human placenta, Tumor cells, CHO, HEK and Fermentation using yeast, E. coli and Streptococcus, benchtop to large scale re-usable or disposable Single Use equipment (SUB). Handling human blood samples for DNA isolation, digestion, and building libraries. Performed Upstream and downstream technical transfer of virus, protein, and biopolymers.

●Skilled in process scale up, automated process controls, analytical methodologies, aseptic process, sterile fill/finish, equipment management, trouble shooting, Problem solving, design & fabrication, Team development/management, document control systems, SOP authoring, Data analysis, LIMS, DCS, MES, DOE, SPC, IQ, OQ and PQ, Change Control, Deviation Investigation and CAPA management.

PROFESSIONAL EXPERIENCE

Pfizer Rocky Mount, NC Jul 2024-Present

Process Engineer (Contract Position)

●cGMP Manufacturing Final Formulation and Fill operations. Performing Tech Transfer for existing products. Verifying quality test results for stability studies, building study models for TTP.

●Create and/or update applicable risk assessment and risk mitigation, as well as CMAs.CQAs.

●Monitored fill operation using Bauch Strobel and Allen Bradley sterile fill equipment.

●To bring a new manufacturing site online, Overseeing the manufacturing activities in a new facility and ensuring the products manufactured in the new facility have similar results as reflected on gLIMS data tracking for potency and stability as the products manufactured in the outdated facility.

ABZENA San Diego, CA May2022-Jan2024

Senior Engineer (MSAT)

●Designed bioreactor plumbing and air handling system and acted as SME for upstream operations.

●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 Trackwise

●Performed Sartorius Fill-it CQV, 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 URS’s, IQs, PQs, OQs, Authored WIs, and SOPs for the manufacturing team, and perform all required training.

●Monitor analytical equipment for performance, update software, and maintain relevant Work Instructions and SOPs for accuracy and robustness. Participated in area 5S.

●Evaluated the flow through single-use centrifuges for clarified harvest material.

●Assisted in solving Safety issues by ordering and setting up safe equipment for use on the floor.

AGC Biologics Bothell, WA Jan 2021-Apr 2022

Upstream Manufacturing Supervisor

●Managed cGMP Manufacturing Cell Culture in SS and Single Use Bioreactors up to 3000L capacity in multiple facilities using Delta-V automation, cell expansion through harvest capture for multiple products.

●Performed internal audits for product changeover, 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-2021

Upstream Manufacturing Scientist (Contract Position)

●Designed CIP and SIP for SS fermenters, yielding fail-safe, clean, and sterile fermentation.

●Performed PQ and OQ of 100L Stainless Steel fermenters, validated improvements.

●Performed bacterial fermentation in 10, 40, and 100 L batches in support of making an effective Covid-19 test kit using MFCS automation in a cGMP facility.

Adverum Biotechnologies. Redwood City, CA Jan 2020- Jun 2020

Manufacturing and Process Development Associate III, Cell Culture

●Participated 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, performing tech transfer for manufacturing in a new location.

●Lead author documents, Equipment IQ to start cGMP manufacturing of new AAV product line.

Tocagen Inc. San Diego, CA May 2015-Dec2019

Development Associate III, Cell Culture & Purification Development

●Performed perfusion cell culture, developed process improvements using microscopy, 5L & 50L Single Use Bioreactors for suspension cultures, and a 10-layer cell-stack for adherent cell cultures for vector production in support of gene therapy for brain cancer.

●Conducted media development experiments using DOE and JMP, formulated cell culture media from raw ingredients, and tested productivity of 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, using various resin types and schemes, using JMP, resulting in effective vector yields.

●Developed downstream strategies using TFF, Hollow fiber UF/DF maximizing product yield.

●Performed experiments using DOE for Hollow fiber vs. cassette UF/DF in purification strategies.

●Analyzed results by protein assays, SDS PAGE, cell-based titer assay, and quantitative qPCR, verifying process improvements in purity and yield.

●Supported cGMP manufacturing by testing samples from process development and manufacturing operations to verify successful tech transfer. Audited documents in preparation for FDA visits.

●Designed and qualified a cold labeling machine for frozen product vials to minimize temperature excursion in the final product.

Avid Bio Services, Tustin, CA Jul 2011- Jan 2014

Process 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 a cGMP facility using MFCS software.

●Authored SOPs, trained operators, and oversaw 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.

●In 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 the downstream purification process.

●Validated the performance 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.

BiogenIDEC. San Diego, CA May 2007 - Jun 20

Associate Scientist II, Upstream pilot scale cell culture development

●Performed fail-safe cultures, minimized contamination by improving the equipment sterilization process.

●Designed bioreactor setup, plumbing, air handling, CIP, and SIP steps leading to reliable, clean, and sterile bioreactors for repeated usage.

●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.

●Performed pilot-scale cell culture runs using Wave, Single Use, and SS bioreactors from 5L up to 400 L using MFCS automation.

●Led projects on multiple processes, improving growth rate and titer results.

●Developed two projects from small scale to successful manufacturing campaigns.

●Performed CQV for analytical and process equipment, resulting in reliable sample processing data.

●Tested temperature, agitation, oxygen, and glucose consumption rates to increase productivity and define successful culture requirements.

●Succeeded in preventing contamination in batches by implementing regular PM on critical equipment and by closely monitoring sterilization processes, avoiding cold spots and dead legs during SIP cycles.

●Performed: Final Formulation DP development, Solubility, buffer robustness, freeze/thaw, color, dilution stability, deamidation, and long-term stability studies for one large molecule protein product.

●Analyzed protein stability using Waters HPLC, SEC, UV Spectrophotometer, DSC, and Hunterlab Color Quest to investigate protein stability when subjecting samples to test environments.

●Finalized formulation, final-fill, and packaging of a product in advance of NDA submission.

Biogen IDEC. Cambridge, MA May 2006- May 2007

Manufacturing Associate IV, Cell culture

●Delta-V operating system produced recombinant protein products in a large-scale cGMP facility.

●Revised manufacturing documents to update procedures as needed.

●Developed a new method to calculate accurate weights and volumes in process vessels, resulting in tight weight tolerances, which reduced deviations and allowed for improved process control.

Cambrex Biosciences, Hopkinton, MA Aug 2004-May 2006

Process 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 to investigate and document deviation issues.

●Process evaluation, equipment commissioning providing 24-hour monitoring of productions.

●Revised and authored manufacturing SOPs for a botulism vaccine.

Genzyme Corporation, Allston, MA Aug 1996 - Apr 2004

Senior Manufacturing Associate

●Participated in the production of large/small scale, sterile or aseptic buffers and purified protein products using Rosemont and Delta V automation systems and a variety of column types.

●Researched, recommended, 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 cross-functional team, including facility auditing for failure investigations. Investigated product failures and contaminations.

Genzyme Corporation, Cambridge, MA Sep 1989 - Aug 199 6

Manufacturing Associate, Fermentation and Purification

●Supervised four or five employees, performing biologics drug development, surgical implant development, CIP/SIP, component prep, media prep, 3L - 180L fermentation, UF/DF, purification, sterile processing, lyophilization, sterile fill and finish operations.

●Validated aseptic fill and packaging of drug products in powder, dry film, gels, and burn cream.

●Assisted in research for the production of multiple biopolymer products and enzymes.

●Performed cell line development, monitored production runs, and collaborated with cross-functional teams to improve production. Performed deviation investigations.

●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 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, proposed corrections, and improved manufacturing.

●Aided in the development to market of Fabrazyme, Synvisc, Hal-C, and Hal-S products. Provided high-density Hyaluronic Acid products for eye surgery, for Alcon, and low-density for surgical implants.

Massachusetts General Hospital, Boston, MA Jun 1988 - Sep 1989

Research Associate, Molecular Biology

●Researched the heredity pattern of Multiple Sclerosis in blood from MS patients & blood relatives.

●Purified blood DNA, building DNA libraries, performing digests and Southern Blots, analyzing data. Helped publish reports that proved hereditary factors of Multiple Sclerosis.

Genzyme Corporation, Boston, MA Jun 1986 - Jun 1988

Manufacturing Technician, Protein Purification

●Extracted, concentrated, and purified protein products from human tissue samples in support of clinical studies using manual extraction techniques & dialysis of the purified products.

●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 Genzyme’s product Cerezyme.

EDUCATION/ AWARDS

B.A. (Biology) Sept 1976 - June 1980 Boston University - Boston, MA

M.S. (did not complete Pharmacology) Sept 1980 - June 1983 Northeastern University - Boston, MA

Twice a recipient of the VP award Genzyme Corp. - Cambridge, MA

Three times achievement awards Genzyme Corp. - Cambridge, MA

Achievement awards Adverum Redwood City, CA[1]

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