Research Scientist - Validations at PPD in Newport, KY
JOB DESCRIPTION PPD, part of Thermo Fisher is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health! Summarized Purpose:
As a Research/Validation Scientist, conducts and provides technical guidance on scientific method development and validation projects in CAP/CLIA Clinical Labs. Designs and executes method development/validation independently and interprets and reviews analytical data for self and others. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes validation reports.
Essential Functions:
o Organizes daily work activities around validations to ensure efficient and effective scientific and administrative operations. o Validates new assays as necessary for upcoming studies. o Write validation plans for new assays. o Write validation summaries of complete validations. o Train medical technologists and laboratory assistants in the proper use of new assay or instrumentation o Assists with administrative duties as requested by laboratory management o Independently performs analytical method development/optimization/validation and/or other specialty technologies studies OR method transfers. o Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. o Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. o Leads analytical (procedural and instrumental) troubleshooting sessions. o Assists business development group in technical sales and marketing, and presents posters at technical conferences. o Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Job Qualification Education and
Experience:
Bachelor's degree in Medical Technology with ASCP certification or equivalent and relevant formal qualification. Previous experience in Clinical Lab Testing in multiple areas like Chemistry, Hematology, coagulation, Immunology etc., that provides the knowledge, skills, and abilities to perform the job (comparable to 8
years). Knowledge, Skills and Abilities:
o Knowledge of general laboratory testing in clinical chemistry, hematology, microbiology, Immunology, molecular Diagnostics etc., o Full understanding of CAP, CLSI guidelines of New Test validation requirements. o Full knowledge of technical operation of Clinical Lab Tests. o Ability to independently optimize analytical methods o Ability to independently perform root cause analysis for method investigations Proven technical writing skills o Proven problem solving and troubleshooting abilities o Effective written and oral communication skills as well as presentation skills o Time management and project management skills o Ability to mentor others on technical operating systems o Ability to independently review and understand project proposals/plans o Ability to work in a collaborative work environment with a team Working Conditions and Environment:
o Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. o Occasional drives to site locations, occasional domestic travel. o Exposure to biological fluids with potential exposure to infectious organisms. o Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. o Personal protective equipment required such as protective eyewear, garments and gloves. o Exposure to fluctuating and/or extreme temperatures on rare occasions. PPD Defining Principles:
- We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
As a Research/Validation Scientist, conducts and provides technical guidance on scientific method development and validation projects in CAP/CLIA Clinical Labs. Designs and executes method development/validation independently and interprets and reviews analytical data for self and others. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes validation reports.
Essential Functions:
o Organizes daily work activities around validations to ensure efficient and effective scientific and administrative operations. o Validates new assays as necessary for upcoming studies. o Write validation plans for new assays. o Write validation summaries of complete validations. o Train medical technologists and laboratory assistants in the proper use of new assay or instrumentation o Assists with administrative duties as requested by laboratory management o Independently performs analytical method development/optimization/validation and/or other specialty technologies studies OR method transfers. o Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. o Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. o Leads analytical (procedural and instrumental) troubleshooting sessions. o Assists business development group in technical sales and marketing, and presents posters at technical conferences. o Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Job Qualification Education and
Experience:
Bachelor's degree in Medical Technology with ASCP certification or equivalent and relevant formal qualification. Previous experience in Clinical Lab Testing in multiple areas like Chemistry, Hematology, coagulation, Immunology etc., that provides the knowledge, skills, and abilities to perform the job (comparable to 8
years). Knowledge, Skills and Abilities:
o Knowledge of general laboratory testing in clinical chemistry, hematology, microbiology, Immunology, molecular Diagnostics etc., o Full understanding of CAP, CLSI guidelines of New Test validation requirements. o Full knowledge of technical operation of Clinical Lab Tests. o Ability to independently optimize analytical methods o Ability to independently perform root cause analysis for method investigations Proven technical writing skills o Proven problem solving and troubleshooting abilities o Effective written and oral communication skills as well as presentation skills o Time management and project management skills o Ability to mentor others on technical operating systems o Ability to independently review and understand project proposals/plans o Ability to work in a collaborative work environment with a team Working Conditions and Environment:
o Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. o Occasional drives to site locations, occasional domestic travel. o Exposure to biological fluids with potential exposure to infectious organisms. o Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. o Personal protective equipment required such as protective eyewear, garments and gloves. o Exposure to fluctuating and/or extreme temperatures on rare occasions. PPD Defining Principles:
- We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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