Linda Kuhns
Rocky Point,NC
Summary
Chemist with over 20 years of experience in the pharmaceutical industry. Highly diversified background in cGMP environment. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Ability to handle multiple projects simultaneously with a high degree of accuracy. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills.
Overview
27
27
years of professional experience
8
8
years of post-secondary education
Work History
Scientist III
Thermofisher Scientific
10.2021 - Current
- Performed peer review of analytical results, protocols, reports and analytical test methods to insure the documents were in compliance with regulatory requirements
- Performed approval for Protocols, Reports, and Certificates of Analysis
- Reviewed/approved investigations/deviations. Addressed non-conformance issues.
- Achieved timely resolution of non-conformance issues by implementing corrective action plans working closely with relevant departments.
- Analyzed quality and performance data to support operational decision-making.
- Analyzed data from product testing, identifying trends and opportunities for improvement in both design and production processes.
- Communicated with client
- Responsible for coordinating and leading analytical aspects for assigned development projects to include protocol writing, protocol execution and final report writing
- Testing to include execution of validation protocols and supporting process development activities
- Testing included Assay/impurities, residual solvents, and moisture determination.
- Mentored junior QA specialists, fostering a culture of continuous learning and professional growth.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Promoted adherence to quality standards by educating personnel on quality control.
- Improved product quality by implementing rigorous testing procedures and identifying areas for improvement.
- Enhanced customer satisfaction by addressing reported issues promptly and providing effective solutions.
- Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
- Created testing protocols to be used across product lines.
- Liaised between quality control and other departments and contractors, providing project updates and consultation.
- Inspected items and compared against standards to meet regulatory requirements.
- Recorded and organized test data for report generation and analysis.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
Scientist II
Recro Gainesville Development
08.2017 - 08.2021
- Lead Analytical Development Projects
- Communicated with client
- Coordinated with project manager to identify and prioritize project requirements
- Responsible for coordinating and leading analytical aspects for assigned development projects to include protocol writing, protocol execution and final report writing
- Testing to include execution of validation protocols and stability testing
- Testing included Assay/impurities, moisture determination, particle size determination, and dissolution
- Performed alcohol dumping study on final product
- Reviewed data and documents to ensure compliance with regulations in addition to company requirements
- Established New Laboratory
- Responsible for ordering instruments and laboratory supplies for new laboratory
- Responsible for qualifying new equipment
- Wrote and executed protocols for qualification of new equipment
- Wrote Standard Operating Procedures for new equipment.
Principal Research Scientist
Ethicon (Kelly Services)
06.2016 - 12.2017
- Acting as a Subject Matter Expert (SME) for a test method validation remediation project
- Performing gap assessments on previous test method validations and determining if re-validation is required based on the company's Chemical Test Method Validation procedure
- Performing pre-validation studies to determine if test methods are suitable for their intended purpose
- Writing and executing validation protocols and writing validation reports
- Training analysts on changes to test methods following validation.
Analytical Chemist
TRC
02.2014 - 06.2016
- Responsible for coordinating and leading analytical aspects for assigned development projects
- Testing to include execution of validation/transfer protocols and stability testing
- Testing included Assay/impurities, particulate matter, microscopic evaluation, extractable/leachable, and wet chemistry
- Instrumentation included: HPLC, UPLC, GC, microscope, and HIAC
- Method Transfer: Participated in activities for transferring test methods from other facilities to our laboratory
- Method Verification: Lead method validation/qualification projects
- This included writing the laboratory studies and protocols, executing those protocols and writing the reports for the executed protocol
- Document writing to include protocols, reports, test methods and specifications
- Reviewed data and documents to ensure compliance with regulatory requirements.
Senior Chemist
Hospira (Kelly Services)
03.2013 - 02.2014
- Routine QC Testing to include in process, final product testing and investigational testing
- Testing included HPLC and wet chemistry testing.
Scientist III
Pfizer
12.2002 - 03.2013
- Method Transfer: Lead projects that transferred test methods from other facilities to our laboratory
- Once the methods were transferred, supported testing new products and trained other analysts on the test method
- Method Validation/Qualification: Lead method validation/qualification projects
- This included writing the laboratory studies and protocols, executing those protocols and writing the reports for the executed protocol
- Method summaries for regulatory affairs for submissions
- Methods included HPLC testing, moisture testing, nephelometry, UV test methods, CE methods and some microbiology testing to include bioburden
- Participated in global studies for implementation of a WHO standard
- Participated in high level problem solving within the company network
- Performed SOP revisions
- Worked with regulatory affairs to assist with FDA responses for the methods I was an SME for
- Designed experimentation to provide additional data to support validations in response to FDA questions
- Lead continuous improvement efforts involving monthly performance verifications for instrumentation
- The improvements resulted in reduced operational costs
- Safety representative for the laboratory and assisted EHS in setting up an electronic MSDS data base for all chemicals within the laboratory.
Chemist 3
Magellan Laboratories
08.2001 - 12.2002
- Structural Chemistry: Physical Organic
- GC and HPLC method development in a GLP/GMP environment
- Leachable / Extractable testing.
Associate Scientist
Applied Analytical Instruments
05.1998 - 08.2001
- HPLC Method Development and Validation Group
- HPLC analysis of pharmaceutical products method development/validation to include disso in vitro assay analysis of lotions
- Routine HPLC analysis of pharmaceuticals
- GMP review of projects
- Final report writing of projects
- GC analysis of pharmaceuticals; to include raw materials and final products
- Analyzed samples using client methods, USP, EP and JP methods
- Duties included routine GC analysis of pharmaceutical products, method development/validations, GMP review and corporate trainer.
Instructor Organic Chemistry Laboratory
Lock Haven University
08.1997 - 05.1998
- Responsible for the laboratory portion of the organic chemistry course to include design and implementation of the laboratory schedule
- Duties included writing quizzes, selecting experiments, setting up the laboratory and grading laboratory reports and quizzes.
Education
Master of Science - Chemistry
The Pennsylvania State University
University Park 08.1992 - 05.1997
Bachelor of Science - Chemistry
Lock Haven University
Lock Haven 08.1989 - 05.1992
Skills
cGMP
References
Available upon request.
Timeline
Scientist III
Thermofisher Scientific
10.2021 - Current
Scientist II
Recro Gainesville Development
08.2017 - 08.2021
Principal Research Scientist
Ethicon (Kelly Services)
06.2016 - 12.2017
Analytical Chemist
TRC
02.2014 - 06.2016
Senior Chemist
Hospira (Kelly Services)
03.2013 - 02.2014
Scientist III
Pfizer
12.2002 - 03.2013
Chemist 3
Magellan Laboratories
08.2001 - 12.2002
Associate Scientist
Applied Analytical Instruments
05.1998 - 08.2001
Instructor Organic Chemistry Laboratory
Lock Haven University
08.1997 - 05.1998
Master of Science - Chemistry
The Pennsylvania State University
08.1992 - 05.1997
Bachelor of Science - Chemistry
Lock Haven University
08.1989 - 05.1992
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