Kennedy Stewart
Raleigh,NC
Summary
Dynamic scientist with expertise in high-performance liquid chromatography and a strong commitment to quality assurance, honed at Eurofins. Proven ability to optimize processes and enhance client interactions, while maintaining meticulous documentation. Adept at troubleshooting and fostering team collaboration to drive successful research outcomes in GMP-compliant environments.
Overview
5
5
years of professional experience
Work History
Scientist I
Eurofins-Cary, NC
Cary, NC
09.2023 - Current
- SME of environmental monitoring department with focus on pharmaceutical compressed air testing and water collection
- Performs high-performance liquid Chromatography (HPLC) analysis, karl fischer (water content) , weight loss testing, appearance, osmolality, non-viable air, viable, aeroest, dew point, and pH testing for stability samples of commercial products
- Conducts client requested research experiments
- Preparation of samples, reagents and standards.
- Travels to client facility to complete sample collection
- Performs necessary preventative maintenance , calibration, and qualification of instruments/devices applicable for stability studies
- Conducts experiments and maintains excellent notebook documentation in a gmp/glp laboratory following Good Documentation Practices and alcoa principles.
- Drafted technical documents such as methods or certificates of analysis and deviation documentation.
- Data review of documentation per gmp/glp practices and alcoa principles and data entry
- Operates data acquisitions system empower 3.
- Compiles data for quantitative analyses using Empower 3 and Microsoft Excel.
- Adherence to standard operating procedures (sops), qa and qc protocols.
- Manages daily activities in the laboratory, including chemical inventory, equipment maintenance and troubleshooting, and waste management
Associate Scientist
Catalent Pharma Solutions (Apex Solutions)-Morrisville, NC
Morrisville, NC
04.2023 - 07.2023
- Under general supervision, performed work that varied and that was somewhat difficult in character, but usually involved limited responsibility.
- Some evaluation, originality or ingenuity was required.
- Followed established protocols and work plans.
- Complied with divisional and site Environmental Health and Safety requirements.
- Executed laboratory work plan / schedule developed with input from supervisor or senior team member.
- Drafted technical documents such as methods or certificates of analysis.
- Performed parallel review of laboratory documentation and became qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance.
- Trained others on laboratory techniques.
- Assisted in the execution of efficiency improvement project with guidance.
- Performed all other duties as assigned
Associate Scientist
Tergus Pharma-Durham, NC
Durham, NC
10.2022 - 03.2023
- Conducted experiments under supervision and maintains excellent notebook documentation in a GMP/GLP laboratory following Good Documentation Practices and ALCOA principles.
- Performed In Vitro Release Testing (IVRT) for topical formulations such as Gels, Creams, Ointments, Films and Ophthalmic Solutions as per customer needs.
- Prepared solutions for IVRT and High-Performance Liquid Chromatography (HPLC) analysis such as Mobile Phase and Buffer.
- Calibrates and operates micro and analytical balances for reference standard and reagent weighing.
- Calibrated and operated pH meter for Buffer solution adjustments.
- Operated data acquisitions system Empower 3.
- Compiled data for quantitative analyses using Empower 3 and Microsoft Excel.
- Managed daily activities in the laboratory, including chemical inventory and equipment maintenance and troubleshooting
- Had capacity to don half face respirator and disposable PPE for hazardous materials.
- Provided support to team members as needed.
- Followed guidelines and SOPs during method development and validation.
- Worked with supervision with peers and leadership to perform troubleshooting activities.
Downstream Operator
Medicago-Durham, NC
Durham, NC
01.2022 - 08.2022
- Executed the intermediate activities for biopharmaceutical production
- Responsibilities involved day-to-day coordination of ongoing biopharmaceutical production, documentation and process efficiency improvements
- Executed the majority of the production processes to meet manufacturing and business requirements;
- Involved in most of the process scale-up, process optimization and process validation activities;
- Adhered to and helped development of documentation, including standard operating procedures and batch records
- Coordinated inventory of consumables for production;
- Supported the generation and resolution of process deviations
- Inspected and maintained the production equipment and control systems
- Collaborated with process support and developed groups to assure smooth process transition in manufacturing
- Supported department management in developing and providing training for the process floor
- Inputed, reviewed, and trended batch production data to support campaign summary report completion
Manufacturing Support Technician
Dendreon Pharmaceuticals-Union City, GA
Union City, GA
09.2021 - 11.2021
- Weighed, measured and checked raw materials to ensure batches manufactured contain proper ingredients and quantities.
- Maintained records to comply with regulatory requirements and acted as subject matter expert for revisions or improvements to manufacturing documents.
- Worked with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.
- Represented department in cross-functional teams, projects and GXP-related problem resolution.
- Posted weights and shipping charges, and prepared goods for final shipment.
- Prepared and maintained records of merchandise shipped.
- Prepared goods for final shipment and unpacked/checked goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary.
- Examined, stocked, and distributed GMP and non-GMP materials to inventory and manufacturing lines.
- Completed duties as assigned
Tech Trainee
Labcorp-Burlington, NC
Burlington, NC
09.2020 - 07.2021
- Determined the acceptability of specimens for testing according to established criteria
- Performed routine and complex technical procedures and functions according to departmental Standard Operating Procedures
- Monitored/operated and troubleshooted instrumentation to ensure proper functionality
- Demonstrated the ability to make technical decisions regarding testing and problem solving.
- Prepared, tested and evaluate new reagents or controls
- Reported accurate and timely tested results in order to deliver quality patient care
- Performed and documented preventive maintenance and quality control procedures
- Identified and replenished testing bench supplies as necessary
- Assisted with processing of specimens when needed
- Maintained a safe work environment and wore appropriate personal protective equipment
Education
Bachelors of Science - Biology, Chemistry
North Carolina A&T State University
Greensboro, NC05.2020
Skills
- Molecular biology
- Invitro
- Client interaction
- Process optimization
- Assay development
- Chromatography techniques
- Particle size analysis
- Research and experiments
- Flow cytometry
- Hypothesis testing
- Peer reviews
- Adaptability and flexibility
- Chemical inventory
- Standard operating procedures
- Biochemistry
- Preventative maintenance
- Data analysis
- Technical documentation
- Sample preparation
- Quality assurance
- Regulatory compliance
- Microscopy
- Scientific research
- Analytical chemistry (three years)
- Problem solving
- Team collaboration
- Attention to detail
- Effective communication
- Environmental monitoring
- Statistical analysis
- Microbiology
- Problem-solving
- Troubleshooting
- High-performance liquid chromatography
- Water testing
- Instrument calibration
- Technical writing
- Equipment maintenance
- GMP compliance
Languages
Spanish - Fluent
Affiliations
- Hosts ticketed public events within the community at local establishments.
Accomplishments
- Superlative Service Award- Eurofins
Languages
Spanish
Professional
Timeline
Scientist I
Eurofins-Cary, NC
09.2023 - Current
Associate Scientist
Catalent Pharma Solutions (Apex Solutions)-Morrisville, NC
04.2023 - 07.2023
Associate Scientist
Tergus Pharma-Durham, NC
10.2022 - 03.2023
Downstream Operator
Medicago-Durham, NC
01.2022 - 08.2022
Manufacturing Support Technician
Dendreon Pharmaceuticals-Union City, GA
09.2021 - 11.2021
Tech Trainee
Labcorp-Burlington, NC
09.2020 - 07.2021
Bachelors of Science - Biology, Chemistry
North Carolina A&T State University
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