Senior Scientist - Validations - ASCP

    • Thermo Fisher Scientific
  • Highland Heights, KY
  • Posted 43 days ago | Updated 1 day ago


On Site
Full Time


Clinical research
Clinical trials
Scientific research
Administrative support
Status reports
Regulatory Compliance
Business development
Technical sales
Quality management
Healthcare information technology
Analytical skill
Root cause analysis
Technical writing
Problem solving
Time management
Project management
Operating systems
Office equipment
Health care
Job boards

Job Details

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Fluctuating Temps hot/cold, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardotoxic materials

Job Description

Sr Scientist

GCL (Global Central Lab) - Highland Heights, Kentucky

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

As a Validation Scientist, conducts and provides technical guidance on scientific method development and validation projects in CAP/CLIA Clinical Labs. Designs and implements 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:

  • Organizes daily work activities around validations to ensure efficient and effective scientific and administrative operations.
  • Validates new assays as necessary for upcoming studies.
  • Write validation plans for new assays.
  • Write validation summaries of complete validations.
  • Train medical technologists and laboratory assistants in the proper use of new assay or instrumentation
  • Assists with administrative duties as requested by laboratory management
  • Independently performs analytical method development/optimization/validation and/or other specialty technologies studies OR method transfers.
  • Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
  • Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs.
  • Leads analytical (procedural and instrumental) troubleshooting sessions.
  • Assists business development group in technical sales and marketing, and presents posters at technical conferences.
  • 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.

Keys to Success


  • 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 5+ years).

Knowledge, Skills and Abilities:

  • Knowledge of general laboratory testing in clinical chemistry, hematology, microbiology, Immunology, molecular Diagnostics etc.,
  • Full understanding of CAP, CLSI guidelines of New Test validation requirements.
  • Full knowledge of technical operation of Clinical Lab Tests.
  • Ability to independently optimize analytical methods
  • Ability to independently perform root cause analysis for method investigations Proven technical writing skills
  • Proven problem solving and troubleshooting abilities
  • Effective written and oral communication skills as well as presentation skills
  • Time management and project management skills
  • Ability to mentor others on technical operating systems
  • Ability to independently review and understand project proposals/plans
  • Ability to work in a collaborative work environment with a team

Working environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary and/or standing for typical working hours.
  • Able to lift and move objects up to 25 pounds.
  • Able to work in non-traditional work environments.
  • Able to use and learn standard office equipment and technology with proficiency.
  • May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! ;/b>

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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