Softmax
Jacques Nakkash
Potomac,Maryland
Summary
Determined and well-rounded individual with more than 15 years working as a Scientist within the Biotech industry. Sharp and focused professional offering skills in Research and Development and Regulatory Compliance. Expert in ELISA assay development, analytical biochemistry, and GxP guidelines. Proven track record in project management, technical leadership, and process improvement
Overview
15
15
years of professional experience
10
10
years of post-secondary education
1
1
Certification
Work History
Scientific Business Analayst
Regeneron
Tarrytown, NY
02.2022 - 06.2023
- Applied honed problem-solving skills to analyze and resolve issues impacting business operations and goal achievement.
- Analyzed key aspects of business to evaluate factors driving results and summarized into presentations.
- Created data models to support decision-making processes.
- Improved business direction by prioritizing customers and implementing changes based on collected feedback.
- Provided scientific solution support for PreClinical Development.
- Worked on migrating desktop templates to web-based eLN solutions.
- Streamlined sample inventory process using Labware LIMS
- Well versed in gathering user requirements, JIRA, Confluence, eLN, multiple LIMS systems, Splunk and LucidCharts for analysis and data flow diagrams to support any project needs
Associate Scientist
MesoScale Diagnostics
Gaithersburg, MD
09.2018 - 04.2020
- Produced statistical reports to correlate with laboratory research.
- Documented changes during experiments, noting unexpected issues arising during research activities.
- Conducted experiments in laboratory environment for product development purposes.
- Developed multiplex assays to meet client needs.
- Oversaw the development of various validated multiplex MSD panels cap able of accurately quantifying more than ten analytes in a single run.
- Served as technical lead for any internal non conformances or specification failures that may have arisen from the complexities of multiplexing and advise on any corrective and preventative actions.
- Participated in contract work with various biotech companies to develop and qualify assays fit for their needs on MSD’s highly sensitive, multiplexed platform.
Associate Scientist
Novavax
Gaithersburg, MD
12.2015 - 09.2016
- Produced statistical reports to correlate with laboratory research.
- Documented changes during experiments, noting unexpected issues arising during research activities.
- Directed development team in the development of a residual impurity assay (ELISA) for the detection and quantitation of SF9 host cell proteins in various sample matrices. Developed a single cell line ELISA assay for the detection and quantitation of Baculovirus (BV) proteins while enhancing efficiency, accuracy, range, throughput, and sensitivity.
- Completely automated data interpretation/results by coding proficient SoftMax templates, proving guidance on assay development/execution, and mentoring junior analysts.
- Developed assays by collaborating with scientists, writing standard operating procedures, and authoring qualification protocols while maintaining upstream demands.
Associate Scientist II
AstraZeneca
Gaithersburg, MD
01.2008 - 12.2015
- Produced statistical reports to correlate with laboratory research.
- Documented changes during experiments, noting unexpected issues arising during research activities.
- Trained newly hired employees on processes and procedures relevant to lab tasks at hand.
- Conducted experiments in laboratory environment for product development purposes.
- Developed multiple in-house ELISA assays to detect residual impurities such as Protein A/residual insulin/residual Host Cell Proteins for multiple cell lines.
- Appointed lead Subject Matter Expert (SME) to develop, optimize and qualify multiple lateral flow identity assays to support IND submissions and comply with FDA regulations (21CFR610 Identity testing). Acknowledged and recognized for developing and qualifying by tight deadlines (see accomplishments section)
- Wrote various standard operating procedures for various analytical methods adhering to compliance with GxP standards. Authored multiple assay qualification plans to qualify residual host cell protein ELISAs across multiple cell lines CHO HCP ELISA, NS0 HSP ELISA, E. Co li HCP ELISA.
- Resolved development assay issues and troubleshot any deviations within the GxP (lot release) groups in collaboration with scientists
- Bridged reports and transferred data to automated platforms and FDA IND sections by writing assay development and qualifications, reagent qualification, and tech transfer reports
- Created multiple (ELISA) assays for both manual and automated platforms for analytical characterization and pipeline drug potency
- Increased throughput and sample turnaround time of plate based ELISA assays by developing and bridging residual methods to the GYROS automated microfluidic platform
Education
Master of Science - Biotechnology
01.2013 - 12.2018
- Relevant Coursework: Bioinformatics
Bachelor of Science - Biological Sciences
09.2003 - 12.2007
- College Park Scholars Graduate
Skills
ELISA
Data analysis
Assay Development
Multiplexing
In-Process Testing
Automation (Gyros/Biacore)
Regulatory GxP Compliance
Technical Writing (SOPs/Reports)
LIMS
Electronic Lab Notebooks
Softmax
Accomplishments
- Awarded the MedImmune Enterprise Thinker 2011 Award by implementing automated Softmax templates saving countless FTE time spent reviewing data
- Invited to speak at 2015 BIOVIA Community Conference on how to integrate electronic lab notebooks into the lab
Software
Graphpad Prism
MSD Methodical Mind
Microsoft Word
Microsoft Excel
Atlassian Confluence
Atlassian JIRA
JMP
Certification
Six Sigma Yellow Belt
Timeline
Scientific Business Analayst - Regeneron
02.2022 - 06.2023
Associate Scientist - MesoScale Diagnostics
09.2018 - 04.2020
Associate Scientist - Novavax
12.2015 - 09.2016
Johns Hopkins University - Master of Science, Biotechnology
01.2013 - 12.2018
Associate Scientist II - AstraZeneca
01.2008 - 12.2015
University of Maryland - Bachelor of Science, Biological Sciences
09.2003 - 12.2007