Summary
Overview
Work History
Education
Skills
Accomplishments
Interests
Work Availability
Timeline
Generic

Hasan Abu Kharma

Associate Director
Baltimore,MD

Summary

Entrepreneurial Associate Director, encouraging leader, and analytical problem-solver knowledgeable about business practices in the regulated/exploratory large-molecule bioanalysis supporting the biopharmceutical industry. Adept at supporting and growing operations with a decisive leadership style and strategic approach to decision making.


Overview

8
8
years of professional experience

Work History

Associate Director

NextCure
Beltsville, MD
01.2022 - Current
  • Provided strategic analysis for manufacturing life cycles, technologies, process validations and robustness.
  • Analyzed impacts of regulatory changes on operations and developed mitigation plans.
  • Set up and ran [Type] meetings between senior leadership and third-party stakeholders to conduct joint operations and cement partnerships.
  • Managed data transfers and proactively resolved issues at manufacturing sites through effective troubleshooting.
  • Directed financial operations and administered budgets.
  • Reviewed proposed regulatory changes and evaluated potential impacts on business operations.
  • Managed [Type] department and coordinated resources across [Number] programs.
  • Kept operations responsive and agile with proactive troubleshooting and problem-solving of routine and complex concerns.
  • Lead teams of up to [Number] personnel, supervising daily performance as well as training and improvement plans.
  • Direct and manage the activities of staff within Bioanalytical Sciences
  • Plan/oversee budgets and resources within the US Bioanalytical Sciences group to ensure alignment with the project and corporate goals and objectives
  • Supervise, coach, and mentor scientific staff
  • Develop scientific, technical, and business strategies to promote the growth of bioanalytical science
  • Coach and guide staff on scientific concepts and technical details of immunogenicity and various bioanalytical methodologies
  • Play a major role in developing and maintaining an innovative culture, encourages risk, and supports the development of its people
  • Manage CRO contracts and bioanalytical aspects of project budgets
  • Contribute to the strategic and scientific direction of the Bioanalytical Sciences Group
  • Attract and retain key talent to build and maintain bioanalytical capabilities
  • Drive alignment with project teams, functional leadership, and governance committees on bioanalytical strategies and resourcing for programs
  • Serve as the bioanalytical subject-matter expert on cross-functional drug discovery and development project teams
  • Provide oversight of bioanalytical CROs to facilitate the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods and ensure quality data and reports are delivered within specified timelines
  • Contribute to the preparation of study protocols, reports, and bioanalytical sections of regulatory submissions (e.g., IND, NDA, BLA) and address relevant queries from regulatory agencies
  • Fulfill management responsibilities concerning Good Laboratory Practices
  • Ensure laboratory operations are compliant with the appropriate regulatory requirements
  • Provide operational insight for efficiency improvement
  • Draft, review, and approve Standard Operating Procedures (SOPs) and other documents related to laboratory projects
  • Single point of control for assigned studies and following confirmation of appropriate education, training, and experience. Study Directors
  • Responsible for the interpretation, analysis, documentation, and reporting of study results for GLP and non-GLP studies
  • Represent, as the Study Director, the single point of study control with ultimate responsibility for the overall scientific conduct of in-house GLP Bioanalytical studies

Manager

NextCure
Beltsville, MD
03.2021 - 01.2022
  • Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals.
  • Controlled costs and optimized spending via restructuring of budgets for labor, capital assets, inventory purchasing and technology upgrades.
  • Reduced process bottlenecks by training and coaching employees on practices, procedures and performance strategies.
  • Delivered feedback to decision-makers regarding employee performance and training needs.
  • Evaluated suppliers to maintain cost controls and improve operations.
  • Supervised labor costs and departmental expenses to remain in line with budget.
  • Maintained professional, organized and safe environment for employees and patrons.
  • Recruited and hired top performers to add talent and value to department.
  • Onboarded new employees with training and new hire documentation.
  • Regulatory and scientific oversight of regulated and non-regulated bioanalytical studies.
  • Analysis, interpretation, and approval of study data
  • Take on project management duties – assigning duties and/or responsibilities and managing resources.
  • Preparation and/or review of validation plans, validation reports, and sample analysis plans.
  • Ensure studies are conducted according to approved plans and applicable SOPs.
  • Initiate new project
  • Preparation and creation of analytical runs, data review, and final reports that are written according to SOPs and ready for QA review.
  • Ensure all study personnel are trained on applicable SOPs, equipment, protocols, and amendments.
  • Maintain metrics to track workflows using business management software.
  • Assist in the development and maintenance of review schedules and functional area metrics as applicable.
  • Preparation and review of SOPs, documents, or protocol deviation documentation associated corrective actions and prompt notification of the Study Director and/or Management.
  • In coordination with management, method development/validation, QA, and Reagent Groups to ensure that adequate resources are available for proper execution of the study.
  • Scheduling and coordination with study review team, addressing findings promptly, with corrective actions.
  • Scheduling and coordination with QA of audit events, including in-process audits. Address and correct issues arising from quality assurance audits promptly.
  • Coordinate with Management, method development and validation staff to troubleshoot methods as needed including conduct and reporting of laboratory investigation
  • Responsible for updating report and project tracking to ensure timelines are being met.
  • May fulfill other jobs/responsibilities as directed by management consistent with skill level and training.

Bioanalytical Specialist

NextCure
Beltsville, MD
02.2020 - 03.2021
  • Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals.
  • Controlled costs and optimized spending via restructuring of budgets for labor, capital assets, inventory purchasing and technology upgrades.
  • Reduced process bottlenecks by training and coaching employees on practices, procedures and performance strategies.
  • Delivered feedback to decision-makers regarding employee performance and training needs.
  • Evaluated suppliers to maintain cost controls and improve operations.
  • Supervised labor costs and departmental expenses to remain in line with budget.
  • Maintained professional, organized and safe environment for employees and patrons.
  • Recruited and hired top performers to add talent and value to department.
  • Onboarded new employees with training and new hire documentation.
  • Regulatory and scientific oversight of regulated and non-regulated bioanalytical studies.
  • Analysis, interpretation, and approval of study data
  • Take on project management duties – assigning duties and/or responsibilities and managing resources.
  • Preparation and/or review of validation plans, validation reports, and sample analysis plans.
  • Ensure studies are conducted according to approved plans and applicable SOPs.
  • Initiate new project
  • Preparation and creation of analytical runs, data review, and final reports that are written according to SOPs and ready for QA review.
  • Ensure all study personnel are trained on applicable SOPs, equipment, protocols, and amendments.
  • Maintain metrics to track workflows using business management software.
  • Assist in the development and maintenance of review schedules and functional area metrics as applicable.
  • Preparation and review of SOPs, documents, or protocol deviation documentation associated corrective actions and prompt notification of the Study Director and/or Management.
  • In coordination with management, method development/validation, QA, and Reagent Groups to ensure that adequate resources are available for proper execution of the study.
  • Scheduling and coordination with study review team, addressing findings promptly, with corrective actions.
  • Scheduling and coordination with QA of audit events, including in-process audits. Address and correct issues arising from quality assurance audits promptly.
  • Coordinate with Management, method development and validation staff to troubleshoot methods as needed including conduct and reporting of laboratory investigation
  • Responsible for updating report and project tracking to ensure timelines are being met.
  • May fulfill other jobs/responsibilities as directed by management consistent with skill level and training.

Research Associate III

NextCure
Beltsville, MD
07.2019 - 02.2020
  • Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations.
  • Collaborated with leadership team to identify relevant questions and determine best methods of collection.
  • Streamlined research processes to meet tight deadlines for multiple projects.
  • Set up equipment, organized inventory and maintained facilities.
  • Evaluated potential subject participants to assess suitability for planned studies.
  • Analyzed and interpreted patterns and trends.
  • Development and qualification of bioanalytical methods to evaluate critical reagents (e.g. SDS-PAGE, ELISA, Octet/Biacore, etc.)
  • Cell-based assay development, optimization, pre-validation, and transfer to internal and external teams (e.g. NAb, Potency, Functional assays, etc.). Generate, characterize, and maintain cell lines.
  • Lead internal discussions regarding bioanalytical assays, author technical reports, author INDs sections, author SOPs, present scientific data at meetings, build and maintain a culture of responsibility and accountability
  • Contribute to increasing assay development throughput through systems, processes, equipment, automation, management, etc.
  • 80% Hands on laboratory work.
  • Provide general operational support.

Research Associate II

NextCure
Beltsville, MD
02.2019 - 07.2019
  • Bioanalytical assay development, validation, sample testing, and transfer to internal and external teams to evaluate immunogenicity, pharmacokinetics, pharmacodynamics, and biomarkers in biofluids (e.g. PK/TK, ADA, CLB/CBA NAb, MSD/ECL, ELISA, DELFIA, Gyrolab, etc)
  • Development and qualification of bioanalytical methods to evaluate critical reagents (e.g. SDS-PAGE, ELISA, Octet/Biacore, etc.)
  • Lead internal discussions regarding bioanalytical assays, author technical reports, author INDs sections, author SOPs, present scientific data at meetings, build and maintain a culture of responsibility and accountability
  • Contribute to increasing assay development throughput through systems, processes, equipment, automation, management, etc.
  • 80% Hands on laboratory work.
  • Provide general operational support.

Research Associate II

Meso Scale Diagnostics, LLC
Rockville, MD
01.2018 - 02.2019
  • Execute on the design of experiments and implement plans with minimal guidance utilizing appropriate protocols
  • Establish schedules and scope of proposed experiments
  • Complete documentation to support testing procedures including data capture, forms, logbooks, and inventory batch records
  • Analyze and prepare reagent and/or assay product documentation, organize and procure needed reagents, perform experiments analyze data and document results
  • Exercise professional judgment to independently analyze experiment data
  • Employ self-reliance in drawing experiment conclusions and interpreting results
  • Initiate the verification of accuracy and validity of data; correct any errors
  • Tender presentations for delivery to peer review groups using clear and concise methodologies
  • Provide descriptive statistical analysis via tables, graphs and other tools for summarizing research results
  • Propose viable options and educated recommendations for next steps
  • Lead general lab maintenance initiatives including maintaining laboratory supplies and equipment
  • Maintain and update electronic inventory list database (using Sharepoint), physical inventory and processing/aliquotting/vialing/labeling materials
  • Prepare, maintain and report reagent inventories for assigned methods
  • Utilize self-reliance in understanding and adhering to laboratory safety precautions and proper use of personal protective equipment
  • Monitor the behaviors of others within the laboratory setting and provide guidance on best practices
  • Specific duties may vary depending upon departmental requirements

Scientist II

Smithers Avanza Bioanalytical Services, LLC
Gaithersburg, MD
11.2017 - 01.2018
  • Perform Ligand-binding assays (e.g
  • ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies
  • Perform analysis including method transfer, development, validation and sample testing in support of GLP studies
  • Perform data interpretation and provide data summaries for studies using Watson LIMS
  • Designing and performing laboratory experiments under minimal supervision in support of transfer, development, and validation studies of PK and immunogenicity studies
  • Analyzing data using excel and Watson LIMS and presenting data to PM/PI and clients
  • Perform study activities to meet the regulatory, GLP, CLIA, GCP, protocol, and SOP requirements
  • Maintain the experimental records and raw data in a secure way to protect the integrity of the data
  • Review and check data generated by other staff as assigned
  • Work safely with potentially hazardous substances and exercise universal precautions
  • Function effectively in a team-oriented atmosphere and work independently when necessary
  • Functioning as a lead scientist for studies and projects
  • Functioning as a member of the Health and Safety Committee
  • Present, audit, and respond to health/safety related audits
  • Respond to and address QC and QA findings.

Scientist I

Smithers Avanza Bioanalytical Services, LLC
Gaithersburg, MD
06.2016 - 11.2017
  • Perform Ligand-binding assays (e.g
  • ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies
  • Perform analysis including method transfer, development, validation and sample testing in support of GLP studies
  • Perform data interpretation and provide data summaries for studies using Watson LIMS
  • Perform study activities to meet the regulatory, GLP, CLIA, GCP, protocol, and SOP requirements
  • Maintain the experimental records and raw data in a secure way to protect the integrity of the data
  • Review and check data generated by other staff as assigned
  • Work safely with potentially hazardous substances and exercise universal precautions
  • Function effectively in a team-oriented atmosphere and work independently when necessary
  • Functioning as a lead scientist for studies and projects
  • Functioning as a member of the Health and Safety Committee
  • Present, audit, and respond to health/safety related audits
  • Respond to and address QC and QA findings
  • Ordering office supplies (with around a $ 12000 annual budget)
  • Training less-experienced laboratory personnel
  • Ordering laboratory supplies and maintaining appropriate stocks of general supplies and project specific supplies
  • Assisting the PM’s/PI’s with project-related tasks such as timeline management, designing experiments, assigning LBA sample dilutions, etc
  • Participating with client calls regarding current and future studies
  • Compiling and analyzing data for issues that need to be brought to the clients’ attention
  • Performing regular monthly Health and Safety inspections on fire extinguishers, eye wash stations, and emergency showers
  • Discovering, assessing, and addressing health and safety risks and concerns such as ensuring there are safe levels of oxygen in a room where a lot of dry ice is handled and reducing the exposure of scientist to splashing specimens
  • Initiating and leading development and validation studies proceeding sample analysis studies
  • Training and explaining concepts and protocols to QA auditors, QC coordinators, and other staff.

Laboratory Support Technician I

Smithers Avanza Bioanalytical Services, LLC
Gaithersburg, MD
06.2016 - 06.2016
  • Prepare assay buffers and reagents
  • Perform daily-annual equipment maintenance
  • Report and document activities with accordance to GLPs, SOPs, and protocol
  • Ensure adequate inventory/supplies are stocked for lab use
  • Work with analysts/PM to prepare labels and aliquot critical reagents, standard and QCs

Scientist/Research Technician

InstantLabs Medical Diagnostics Corporation
Baltimore, MD
07.2015 - 06.2016
  • Assisting in the development of new molecular diagnostics tests for the InstantLabs RT-PCR device
  • Preparing, assembling, and performing quality control procedures on commercial test kits and reagents
  • Optimizing PCR and lyophilization methods

Laboratory Teaching Assistant

Washington College
Chestertown, MD
08.2013 - 12.2013
  • Preparing and assisting in demonstrating various laboratory skills and explaining relevant biological concepts and lab procedures to students
  • Preparing and replenishing stock solutions, buffers, and reagents
  • Certifications and Training
  • Artel Pipetting, GCP, and GLP
  • Abu Kharma, HasanPage 3 of 3

Education

Bachelor Of Science - Biology

Washington College

Skills

Strategic leadership

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Accomplishments

  • Supervised team of 4 staff members.
  • Collaborated with team of 10+ in the building of a new GLP laboraotry.

Interests

Hiking

Climbing

Organization Development

Data Analytics and Modeling

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Associate Director

NextCure
01.2022 - Current

Manager

NextCure
03.2021 - 01.2022

Bioanalytical Specialist

NextCure
02.2020 - 03.2021

Research Associate III

NextCure
07.2019 - 02.2020

Research Associate II

NextCure
02.2019 - 07.2019

Research Associate II

Meso Scale Diagnostics, LLC
01.2018 - 02.2019

Scientist II

Smithers Avanza Bioanalytical Services, LLC
11.2017 - 01.2018

Scientist I

Smithers Avanza Bioanalytical Services, LLC
06.2016 - 11.2017

Laboratory Support Technician I

Smithers Avanza Bioanalytical Services, LLC
06.2016 - 06.2016

Scientist/Research Technician

InstantLabs Medical Diagnostics Corporation
07.2015 - 06.2016

Laboratory Teaching Assistant

Washington College
08.2013 - 12.2013

Bachelor Of Science - Biology

Washington College

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Hasan Abu KharmaAssociate Director