Principal Research Associate Resume Example
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PRINCIPAL RESEARCH ASSOCIATE
Professional Summary
- Well-qualified Principal Research Associate motivated to learn, grow and excel in the pharmaceutical industry by acquiring new skills related to regulatory affairs. Offering 15 years of experienced in the Pharmaceutical industry with proficient knowledge of Good Manufacturing and Laboratory practices, USP test methods, and ISO quality standards. Qualifications enhanced by basic knowledge of ICH guidelines and CFR Title 21. Enterprising professional always pursuing ways to streamline or optimize processes. Well-coordinated in handling study documentation and records. Motivated and eager to contribute to team success through hard work, attention to detail, and excellent organizational skills. Skilled at preparing Quality reports required for submission for regulatory filings. Analytical professional focused on making sure materials, products and test methods used in Quality organization meet all relevant domestic and international regulatory requirements. Accomplishments
- Area Lead for managing and organizing the initiatives required to meet FDA recommendations such as Data Integrity initiatives to ensure area work is within laboratory control, reduce the number of personnel errors, and ensure adherence to regulatory and company guidelines.
- Collaborated with quality team to meet regulatory requirements by authoring/reviewing and providing documents required for regulatory submissions, which lead to the successful regulatory approval of Eli Lilly products, such as Emgality and Trulicity.
- Area team lead for implementation of Smartlab as an electronic system for documenting and tracking microbiological identifications. Implementation of Smartlab harmonized our site lab with Global quality systems.
Skills
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Work History
Principal Research Associate, 03/2021 to Current
Principia Biopharma Inc.
Principia Biopharma Inc.
- Lead investigator for investigations related to Quality Control.
- Gathered and arranged quality control data to create representative graphs and charts highlighting results for presentations related Data Integrity investigations to be presented to regulatory agencies.
- Streamlined laboratory processes related to implementation of second person verification by incorporating standard work and lean practices.
- Authored/Reviewed protocols, reports, change records regarding method suitability of raw materials, in-process, and drug substances.
- Collaborated with staff to develop and implement process improvement of the microbiological method verification/validation program.
Senior Research Associate, 03/2016 to 02/2021
Axalta Coating Systems
Axalta Coating Systems
- Assisted with regulatory product compliance initiatives related to data integrity and method process improvements.
- Prepared and submitted quality reports required for regulatory file applications and supporting documentation.
- Initiated, planned and executed quality control projects related to SmartLab implementation, DMSO Investigation and Change Control for USP alignment of Bioburden method incubation requirements.
- Assisted with pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors by providing documents, inspection readiness within the labs, lead/assisted lab tour with regulatory officials, and ensuring laboratory compliance with regulatory recommendations and observations.
- Designed and managed execution of study protocols and authored associated reports.
- Communicated project status to area management verbally and through technical documentation and presentations for Data review and inspection readiness boards.
- Collaborated with other sites on investigations and test method process improvements.
- Interacted with cross functional areas on studies, investigations, and training initiatives.
- Performed research into USP requirements to increase knowledge and ability to provide valuable contributions.
- Wrote investigations within in Microbiology Quality Control laboratory.
- Contributed to KPI monitoring through providing data on laboratory assays, reviews and investigations.
- Reviewed method verification data to assess compliance with USP regulations and company procedures.
- Wrote or updated standard operating procedures, work instructions or policies.
- Tracked key metrics and input data into spreadsheets.
- Led method verification team in delivery of USP alignment with microbiological incubation requirements, resulting in ensuring regulatory submissions of impacted Eli Lilly products.
- Managed Success factors training system by maintaining curricula and documenting area training records.
- Trained entry-level analysts on company protocols, best practices and quality procedures.
- Developed team communications and information for meetings related to microbiological projects and initiatives.
Research Associate, 06/2012 to 03/2016
Gladstone Institutes
Gladstone Institutes
- Contributed to validation of the Vitek2 upgrade by authoring the installation protocol, overseeing execution of protocol, and performing execution of operational protocol.
- Identified microorganisms using MICROSEQ Analyzer, VITEK, API strips, and supplemental tests.
- Ensure Quality Control departments are in compliance with safety regulations as Department Safety Representative.
- Manage Department training records, Assist On the Job Trainers and trainees, and collaborated with department managers as Senior Department Learning Management Administrator.
- Performed Macroscopic identification of Mold isolates recovered from test samples.
- Supported projects by providing microbiological testing, data collection, result analysis and final reports.
- Maintained multiple laboratory inventories using the SAP system and internal tracking of materials for microbiological testing.
- Conducted bioburden method verification/validation and sterility testing of manufacturing samples.
- Analyzed biological data about relationships between organisms and environment through the microbiology identification process.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity such as operation of the Genetic Analyzer for identification testing.
- Ensure 100 % compliance of federal regulations by performing internal laboratory audits and provided support during regulatory inspections.
Quality Technician /Senior Technician, 02/2006 to 02/2012
ImClone Systems Incorporated
ImClone Systems Incorporated
- Initiated and Implemented department rollover of training records to an electronic Learning Management System.
- Authored and revised General Reports, Standard Operating Procedures (SOPs), Material Specifications and other official documents and conducted training on new documents and revisions.
- Generated trend reports for environmental monitoring samples.
- Investigated and documented environmental monitoring/utility excursions.
- Performed media qualifications of microbiological materials.
- Performed bioburden and endotoxin testing of utility samples.
- Performed microbiology identification of in-process, environmental monitoring and utilities samples.
- Performed Routine and non-Routine Environmental Monitoring and Water Sampling of all manufacturing and laboratory areas and documented using MODA electronic database.
Alpharma, 06/2005 to 02/2006
Microbiologist I
Microbiologist I
- Reviewed and audited laboratory notebook and logbooks.
- Performed bioburden testing for in-process samples and finished products.
- Conducted microbial limits, and sterility testing for raw materials and finished products.
- Sampled and tested clean purified water systems.
- Identified microorganisms using Rapid ID tests.
- Responsible for data management of analytical test results including pH, total organic compound and conductivity data.
- Performed qualification testing of in-house and purchased materials.
- Conducted Environmental monitoring of manufacturing and laboratory areas.
- Led laboratory training for new lab technicians.
- Prepared media, scheduled servicing of laboratory equipment and ordered supplies.
Team lead Associate
- Validations group which entailed providing guidance and support to a group of 4 of my co-workers focusing on microbiological method suitability and material qualification.
- Key member of the site method validation and verification for Bamlanivimab, Eli Lilly's therapeutic treatment drug for Coronavirus-19.
- As lead investigator, documented and resolved sterility method verification of raw material, Dimethyl Sulfoxide which led to discovering that the method required to be modified and saved the company money from having to submit the sample for contract testing.
- Lead a collaboration with a team of 2 in aligning method verification practices with USP requirements and ensure regulatory requirements are met for molecule submissions.
- Lead in revising the house isolate program, which is used for compendial microbiological testing.
- Lead Area implementor of Success Factors Electronic data system for site wide training documentation.
- Provided ongoing management of area training records and collaboration with cross functional areas to ensure training curricula are current and compliant with company policies.
- Contributed to the start-up and maintenance of a new manufacturing facility.
- Assisted with lab equipment validations, investigational studies, method development, and inspection readiness.
- Successfully assisted with resolving mold contamination affecting laboratory supplies which saved the company over$50K.
Education
Bachelors of Science Degree: Life Science and PsychologyRutgers University
Associates Degree: Health Science (NursingBergen Community College
Lead Investigation Training, Technical Writing, Data Integrity Training, PDA –Mycology Training HACH –Cleanroom Regulations and Monitoring ARTEL – Pipetting Proficiency Steven
Project Management WD Communications - Professional Communication, Technical Writing New Horizons – Microsoft Office
Work History
Team lead Associate,
- Validations group which entailed providing guidance and support to a group of 4 of my co-workers focusing on microbiological method suitability and material qualification.
- Key member of the site method validation and verification for Bamlanivimab, Eli Lilly's therapeutic treatment drug for Coronavirus-19.
- As lead investigator, documented and resolved sterility method verification of raw material, Dimethyl Sulfoxide which led to discovering that the method required to be modified and saved the company money from having to submit the sample for contract testing.
- Lead a collaboration with a team of 2 in aligning method verification practices with USP requirements and ensure regulatory requirements are met for molecule submissions.
- Lead in revising the house isolate program, which is used for compendial microbiological testing.
- Lead Area implementor of Success Factors Electronic data system for site wide training documentation.
- Provided ongoing management of area training records and collaboration with cross functional areas to ensure training curricula are current and compliant with company policies.
- Contributed to the start-up and maintenance of a new manufacturing facility.
- Assisted with lab equipment validations, investigational studies, method development, and inspection readiness.
- Successfully assisted with resolving mold contamination affecting laboratory supplies which saved the company over$50K.
Principal Research Associate, 03/2021 to Current
NA
NA
- Lead investigator for investigations related to Quality Control.
- Gathered and arranged quality control data to create representative graphs and charts highlighting results for presentations related Data Integrity investigations to be presented to regulatory agencies.
- Streamlined laboratory processes related to implementation of second person verification by incorporating standard work and lean practices.
- Authored/Reviewed protocols, reports, change records regarding method suitability of raw materials, in-process, and drug substances.
- Collaborated with staff to develop and implement process improvement of the microbiological method verification/validation program.
Senior Research Associate, 03/2016 to 02/2021
Company Name
Company Name
- Assisted with regulatory product compliance initiatives related to data integrity and method process improvements.
- Prepared and submitted quality reports required for regulatory file applications and supporting documentation.
- Initiated, planned and executed quality control projects related to SmartLab implementation, DMSO Investigation and Change Control for USP alignment of Bioburden method incubation requirements.
- Assisted with pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors by providing documents, inspection readiness within the labs, lead/assisted lab tour with regulatory officials, and ensuring laboratory compliance with regulatory recommendations and observations.
- Designed and managed execution of study protocols and authored associated reports.
- Communicated project status to area management verbally and through technical documentation and presentations for Data review and inspection readiness boards.
- Collaborated with other sites on investigations and test method process improvements.
- Interacted with cross functional areas on studies, investigations, and training initiatives.
- Performed research into USP requirements to increase knowledge and ability to provide valuable contributions.
- Wrote investigations within in Microbiology Quality Control laboratory.
- Contributed to KPI monitoring through providing data on laboratory assays, reviews and investigations.
- Reviewed method verification data to assess compliance with USP regulations and company procedures.
- Wrote or updated standard operating procedures, work instructions or policies.
- Tracked key metrics and input data into spreadsheets.
- Led method verification team in delivery of USP alignment with microbiological incubation requirements, resulting in ensuring regulatory submissions of impacted Eli Lilly products.
- Managed Success factors training system by maintaining curricula and documenting area training records.
- Trained entry-level analysts on company protocols, best practices and quality procedures.
- Developed team communications and information for meetings related to microbiological projects and initiatives.
Research Associate, 06/2012 to 03/2016
Company Name
Company Name
- Contributed to validation of the Vitek2 upgrade by authoring the installation protocol, overseeing execution of protocol, and performing execution of operational protocol.
- Identified microorganisms using MICROSEQ Analyzer, VITEK, API strips, and supplemental tests.
- Ensure Quality Control departments are in compliance with safety regulations as Department Safety Representative.
- Manage Department training records, Assist On the Job Trainers and trainees, and collaborated with department managers as Senior Department Learning Management Administrator.
- Performed Macroscopic identification of Mold isolates recovered from test samples.
- Supported projects by providing microbiological testing, data collection, result analysis and final reports.
- Maintained multiple laboratory inventories using the SAP system and internal tracking of materials for microbiological testing.
- Conducted bioburden method verification/validation and sterility testing of manufacturing samples.
- Analyzed biological data about relationships between organisms and environment through the microbiology identification process.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity such as operation of the Genetic Analyzer for identification testing.
- Ensure 100 % compliance of federal regulations by performing internal laboratory audits and provided support during regulatory inspections.
Quality Technician /Senior Technician, 02/2006 to 02/2012
Company Name
Company Name
- Initiated and Implemented department rollover of training records to an electronic Learning Management System.
- Authored and revised General Reports, Standard Operating Procedures (SOPs), Material Specifications and other official documents and conducted training on new documents and revisions.
- Generated trend reports for environmental monitoring samples.
- Investigated and documented environmental monitoring/utility excursions.
- Performed media qualifications of microbiological materials.
- Performed bioburden and endotoxin testing of utility samples.
- Performed microbiology identification of in-process, environmental monitoring and utilities samples.
- Performed Routine and non-Routine Environmental Monitoring and Water Sampling of all manufacturing and laboratory areas and documented using MODA electronic database.
Alpharma, 06/2005 to 02/2006
Company Name
Company Name
- Reviewed and audited laboratory notebook and logbooks.
- Performed bioburden testing for in-process samples and finished products.
- Conducted microbial limits, and sterility testing for raw materials and finished products.
- Sampled and tested clean purified water systems.
- Identified microorganisms using Rapid ID tests.
- Responsible for data management of analytical test results including pH, total organic compound and conductivity data.
- Performed qualification testing of in-house and purchased materials.
- Conducted Environmental monitoring of manufacturing and laboratory areas.
- Led laboratory training for new lab technicians.
- Prepared media, scheduled servicing of laboratory equipment and ordered supplies.
Affiliations
Parental Drug Association (PDA) American Society for Quality (ASQ)
Skills
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Resume Overview
School Attended
- Rutgers University
- Bergen Community College
Job Titles Held:
- Principal Research Associate
- Senior Research Associate
- Research Associate
- Quality Technician /Senior Technician
- Alpharma
- Team lead Associate
Degrees
- Bachelors of Science Degree : Life Science and Psychology
Associates Degree : Health Science (Nursing
Lead Investigation Training, Technical Writing, Data Integrity Training, PDA –Mycology Training HACH –Cleanroom Regulations and Monitoring ARTEL – Pipetting Proficiency Steven
Project Management WD Communications - Professional Communication, Technical Writing New Horizons – Microsoft Office
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