Robert Schartner Email & Phone Number

Cambridge, Massachusetts, United States

• Established and led the setup of a plasmid laboratory, meticulously planning, evaluating, and ordering instrumentation for cleanliness, flexibility, and space optimization.• Pioneered in-house plasmid capabilities from transformation through purification and linearization, significantly reducing lead times for internal discovery group requests by over 70%.• Conducted plasmid scale-ups in 1L shake flasks and the AMBR250M bioreactor system, including the development and troubleshooting of software protocols for AMBR250M.• Developed internal plasmid characterization assays for release, incorporating spectrophotometry, LAL endotoxin analysis, and agarose gel electrophoresis.• Collaborated with the analytics team to establish fragment analysis and qPCR methods for internal plasmid characterization.• Evaluated outsourced Sanger sequencing raw data in Geneious Prime as part of plasmid characterization efforts.• Created and evaluated development cell banks to enhance process reliability.• Led the workflow to onboard external vendors for plasmid giga-preps, reducing lead times for external preparations by over 60%.• Executed In vitro-Transcriptions of mRNA using various amounts and purification methods, such as Lithium Chloride precipitation, QIAGEN kits, and AKTA columns.• Evaluated pDNA and mRNA purity with the Agilent Fragment Analyzer, utilizing ProSize software for data analysis.• Tech-transferred outside protocols and assessed them for process improvement efforts.• Authored, reviewed, and edited SOPs (Standard Operating Procedures) and Technical Reports.

Bothell, Wa

• Utilized Sartorius automated bioreactor systems (AMBR15, AMBR250) for clone screens in early-stage projects.• Planned, constructed, and maintained 3L glass bioreactors for a chemically defined media development program, employing multivariate analysis.• Optimized a high-density perfusion culture for feasibility in manufacturing using the ATF system.• Operated within cGMP manufacturing suites to produce clinical and commercial molecules.• Managed the entire lifecycle of cultures from 1ml vial thaw through to 2000L bioreactor, conducting daily sampling and analysis while ensuring process sterility and maintaining critical parameters within range.• Adjusted parameters in the user interfaces (Wonderware/Unicorn/Applikon/Delta V) of stainless steel fermentors, GE disposable bioreactors, 3L glass bioreactors, and PAS monitoring systems.• Collaborated on risk assessments in response to deviations and implemented associated CAPAs.• Designed single-use bioreactor bags to enhance facility layout efficiency.• Contributed to the creation of an in-house Master Cell Bank within the BSC.• Compounded, filtered, and evaluated media and solutions, including integrity testing of filters to ensure sterility.• Served as a subject matter expert for group analytical equipment, overseeing procurement, onboarding, validation, preventive maintenance scheduling, and troubleshooting.• Collaborated with the tech transfer group to author, review, and revise Batch Records and Standard Operating Procedures for new processes and continuous improvement.• Utilized the Discoverant data management system for comparing and analyzing data from multiple runs across various molecules, enabling early detection of variations in process attributes.

Zymogenetics Bothell, Wa

• Conducted daily sampling and analysis of cultures, ensuring maintenance of process parameters and preserving sterility.• Adjusted parameters in the user interface (Wonderware/Unicorn) of stainless steel fermentors, GE disposable bioreactors, and PAS monitoring systems to sustain cultures and alert deviations from set points.• Built and maintained stainless steel centrifuge, homogenizer, and fermentor, overseeing processing and cleaning activities, including using the CIP/SIP interface and associated parts/chemicals.• Compounded, filtered, and evaluated media and solutions, conducting integrity testing of filters to provide evidence of sterility.• Executed the movement of cultures between disposable flasks and bioreactors while maintaining complete sterility using aseptic techniques with disposable materials.• Reviewed and revised Material Batch Records for continuous improvement of processes.• Managed the ordering and allocation of materials for specific drug substance lots for the Upstream Manufacturing Department, utilizing SAP.

Zymogenetics Bothell Wa

• Responsible for activities associated with the disposition of QC-Released Raw Materials.• Performed sampling and inspection of raw chemicals and consumable materials for use in manufacturing.• Managed work and delivery schedules effectively according to project management principles.• Experienced in proper sterile gowning and movement through a clean manufacturing facility.• Performed FTIR identification analysis on a variety of chemicals for USP compendia testing.• Participated in the determination of non-conformities for corrective/preventive actions to assure problem resolution.• Communicated and coordinated with Materials Management for shipping and receiving of raw materials and samples.• Authored material specifications and certificates of analysis for further use in manufacturing.

Biorad Woodinville Wa

• Plate coated enzymes onto PCR microplates.• Bottled prepared reagents using a bottling machine.• Labeled, assembled and finished packaging of kits for shipment.• Utilized GMP to standardize kits and minimize mistakes.

Hampton, Nh

• Responsible for daily monitoring of EPA dredge sediment testing on various polychaetes, crustaceans and mollusks.• Prepared samples and performed Elutriate Toxicity testing for suspended particulate toxins.• Maintained test organism cultures including water quality measurements, adjustments, observations and gender classification for post-treatment results.• Managed and performed homogenization, formulation and manipulation of sediments used for testing.• Designed, constructed and troubleshot large scale multi-sample plumbing structures to house and aerate tests containers.• Resolved issues related to broken or damaged lab equipment.• Authored and Revised SOPs.

Hampton Nh

• Conducted acute and chronic water quality assays using various crustacean and fish species.• Monitored water quality measurements and adjust testing conditions based on observed deviations.• Preparing and mixing solutions of known concentrations used for calibrations, positive controls and negative controls.• Received, logged and tacked samples and organisms through the laboratory including verifying a Chain of Custody.

Manchester, Nh

• Performed interactive demonstrations teaching children basic physics concepts.• Maintained, trouble shot and constructed physics based exhibits.• Interacted with museum guests from a variety of backgrounds making physics concepts relatable and easy to understand.