Jonathan Kral Email & Phone Number

Summit, New Jersey, United States

● Directly supported the execution of IOQ (Installation and Operational Qualification) and IQ (Installation Qualification) for Sepax cell processing units, ensuring compliance with GMP and regulatory standards.● Provided cross-functional support to the team primarily assigned to Cell Therapy Unit's (CTU), assisting in open-door studies and equipment requalification to maintain validated status.● Collaborated on the IOQ and PQ of the Cell Processing Unit, revising and optimizing protocols during dry run activities for enhanced process efficiency.● Collaborated with external vendors for BACT and FACSCanto units, ensuring adherence to company standards for Good Documentation Practices (GDocP) during equipment qualification.● Reviewed and revised vendor-written qualification protocols, bringing them to an approval-ready state before submission for review and QA approval.● Ensured smooth coordination between vendors and internal stakeholders to maintain timely execution of qualification activities.● Consistently completed internal company trainings ahead of deadlines, staying current with process revisions and maintaining full compliance with regulatory and operational standards.● Gained hands-on experience executing qualification activities in both Quality Control labs and Manufacturing Operations cleanroom environments, ensuring adherence to sterile procedures and GMP.

Nutley, Nj

● Authored SOP’s and batch records, namely my designated chromatography process and the Labconco Freeze Dryer instrument with detailed information including steps to perform processes and maintenance. Additionally authored chromatography unit-op portion of technical report, capturing elements of work conducted such as preliminary experiments for resin selection, management of contamination outside of cleanroom setting by using various aseptic techniques and performance of the column over multiple runs.● Performed column chromatography weekly as primary operator during controlled process, scaling up from 20mL to 200mL and packing resins routinely at end of lifetime over the course of several runs. Familiar with Unicorn software and AKTA chromatography system. Additionally, assessed color accumulation on resin over the course of several runs and utilized analytical techniques to assess cause and conducted small-scale experiments with various solvents to remove color while maintaining binding capacity.● Attended all PFMEA discussions with team members regarding each unit-operation to ensure cGMP compliance, leading both the chromatography and lyophilization discussions.● Performed lyophilization of final product weekly as operator during controlled process, utilizing sterile techniques including handling material in BSC, from prepping material for lyophilization to handling dry product and bagging after completion. ● Directly assisted team with weekly centrifugation harvests of material handed off from fermentation for collection of secreted target protein in supernatant for use in multi-unit-operation DSP purification.● Responsible for laboratory safety and emergency equipment.● Trained in BSL laboratory safety measures.

Nutley, Nj

● Assisted in purification of 32 novel molecules with salt precipitation and TFF.● Conducted small-scale experiments using Cytiva’s AKTA chromatography system to screen for most optimal resin and conditions of 50kDa target protein for biomedical applications before scale-up efforts began.● Wrote protocol for, and routinely setup as primary operator, Odor Panel testing to assess smell of final product of 50kDa protein to be used in formulations for beauty applications. Test involved staging bench space in lab to hold samples, a list of team members to perform the test and a subjective questionnaire for each team member to fill out covering various aspects of the samples’ odor for analysis.Publications:● Dai, L. et. al. “Cosmetic potential of a recombinant 50 kDa protein”. Cosmetics, 2022, 9(1).

Nutley, Nj

● Performed weekly small-scale DSP experiments in effort to remove color of 50kDa target protein to be used for beauty applications, as well as assessing color with colorimeter instrument.● Setup, created SOP for and routinely conducted enzyme activity assay utilizing ISE probe to measure fluoride ions released from hydroxylation of synthesized substrate based on literature.● Validated ELISA assay for quantitation of target enzyme for hydroxylation purposes, authored SOP and performed assay as primary operator routinely for this and each proceeding role.

Nutley, Nj

● Greatly assisted in development of novel ELISA based assay for detection of trimeric collagen with guidance of High Throughput Screening manager from ground up.● Routinely ran ELISA once developed as main user for Strain Engineering team’s analytical needs, independently growing and purifying proteins needed for immunoassay.● Member of company’s safety committee where incident prevention and safety contests were routinely discussed.

Brooklyn, Ny

● Regulated, labeled and handled laboratory waste including hazardous, biohazard, non-RCRA, sharps, broken glass and nonhazardous. Includes both solid and liquid waste.● Maintained safety cabinet and storage room and its stock of consumable products for use in labs.● Wrote purchase order forms for company purchases requiring CTO and CEO approval.● Received incoming packages via front entrance and loading dock including large, pallet bound instruments.

Bachelor Of Science (B.S.), Biochemistry

History Applications and Recycling of Polymers Jonathan Kral* Curtis McCormack, Jessica Epstein, Michael Castaldi, Dan Kosciuszko Mid.

High School Diploma