Validation Scientist Job Description
Validation scientist
provides scientific and technical guidance and serve as SME for flow cytometry, molecular and cellular analytical capabilities.
Validation Scientist Duties & Responsibilities
To write an effective validation scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included validation scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Supports clinical biomarker and/or companion diagnostic (CDx) assay development through internal laboratory work
Under guidance of the senior level scientist (s), develop optimal experimental plans and troubleshoot experiments in lab on as needed base
Responsible for routine operation in the lab under guidance of senior level scientist(s) and/or lab manager
Assist with clinical biomarker assay development, validation and transfer to designated CROs
Participate in assessing new clinical biomarker and/or CDx technologies enable evaluation and/or implementation of various technologies building internal lab capabilities
Work in lab for method development, equipment maintenance and provide hands-on lab training of other scientists
Assist in implement and maintain quality procedures & documentation in lab that comply with site procedures and regulatory requirements
Contribute to evaluation data from internal lab work and prepares summary presentations or documents
Responsible for design and execution of well-defined experiments in lab
Evaluate data from internal lab(s) and/or or external collaborators/partners/ contract research organization (CROs)
Validation Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Validation Scientist
List any licenses or certifications required by the position: ASCP, MLS
Education for Validation Scientist
Typically a job would require a certain level of education.
Employers hiring for the validation scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Biology, Science, Engineering, Cell Biology, Education, Biochemistry, Chemical Engineering, Statistics, Life Sciences
Skills for Validation Scientist
Desired skills for validation scientist include:
Applications and software
Calculation of sample sizes
Estimation of statistical power
Flow cytometry instrument platforms
Statistics
Assay panel development and customer workflows
Cellular and molecular immunology
Customer workflows
Scientific principles
CGMP
Desired experience for validation scientist includes:
Contribute ideas and suggestions to improve standard laboratory techniques, protocols, and processes
Comply with company health and safety regulations & procedures
Highly self-motived and proactive
Able to work independently toward defined goal(s)
Excellent prioritization and organizational skills combined with flexibility to meet changing priorities
Demonstrate a consistently high level of quality of work
Validation Scientist Examples
1
Validation Scientist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of validation scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for validation scientist
- Maintains up-to-date knowledge of customer workflows and scientific advancements in flow cytometry
- Support clinical biomarker and/or companion diagnostic (CDx) assay development, validation & transfer through conducting internal laboratory work and/or monitoring of CROs), in vitro diagnostics (IVD) manufacturing and/or testing partner
- Responsible for daily lab operation and ensure safe laboratory practices
- Implement and maintain quality procedures in lab that comply with site procedures and regulatory requirements
- Provide technical training/mentorship for associate scientist (s)
- Contribute to implementation of “fit for purpose” clinical biomarker assay development and transfer
- Participate in TIPs and/or other internal/external collaborators/partners’ biomarker assay transfer & alignment meeting on as needed base
- Act as subject matter expert (SME) and provide support in exploratory biomarker hypothesis testing & generation according to biomarker development plan(s)
- Contribute to preparation and update of biomarker prioritization lists in alignment with other relevant functions
- Test preparation
Qualifications for validation scientist
- Previous experience in clinical biomarkers, translational research, regulated assay development/transfer and or CDx development in a pharmaceutical/biopharmaceutical setting
- Previous hands-on experience with clinical molecular assay, or histopathology
- Familiarity with multiple biomarker assay technologies
- Hands-on expertise using flow cytometry to identify subsets of immune cells, including Myeloid-derived Suppressor Cell (MDSCs), from in vitro cell cultures and tumor infiltrates
- Clinical genomic lab experience
- Trained in the use of statistical analysis software
2
Validation Scientist Job Description
Job Description Example
Our growing company is hiring for a validation scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for validation scientist
- Designing controlled validations for bringing in enhancements to clinical WGS
- Designs and executes all aspects of molecular assay development and validation for molecular/genomics (biomarker) Real Time PCR projects
- Laboratory duties, including evaluating applications on new and existing Triple Quadrupole, Ion Trap and Hybrid LCMS platforms in support of research
- Define the goals and needs in areas of informatics expertise
- Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis on a project basis
- Understands regulatory trends in industry and able to make connection between those trends and established corporate direction
- Designs and executes method development/validation and/or extractable/leachable studies independently and interprets and reviews analytical data for self and others OR designs and executes multiple stability and inhalation procedures assists others in performing routine maintenance and troubleshooting on LC/MS and multiple detection techniques,methods and procedures
- Follows validated or experimental bioanalytical procedures with periodic direct supervision
- Contribute assay development expertise to multiple project teams focused on neurodegeneration and neuroinflammation with a particular focus on using BRET/FRET, photoswitchable fluorophores, HTRF, AlphaScreen and other technologies to detect and quantify protein-protein interactions
- Assist in generating primary neuronal cultures, maintain and differentiate iPSC-derived neuronal / hematopoietic progenitors, generate stable and inducible expression of transgenes in mammalian cells, use siRNA and CRISPR/Cas9 to modulate gene expression in cell culture
Qualifications for validation scientist
- Assist with training of laboratory personnel as needed/ assigned
- Up to 10%l travel
- Proved in-depth expertise and hands-on experience in a variety of nucleic acid extraction and clinical molecular & genomic techniques
- Working knowledge of a variety of cellular and biochemical assays
- Demonstrated ability to interpret and summarize scientific data in an accurate and concise manner
- Strong understanding of quality-related operational and laboratory compliance requirements (CAP/CLIA, GCP, GLP ) necessary for clinical biomarker and /or CDx development in a design control environment
3
Validation Scientist Job Description
Job Description Example
Our company is looking for a validation scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for validation scientist
- Execute on planned experimental design, collect data, interpret/analyze results and present conclusions
- Generate robust and complete data sets to validate novel drug targets
- Design of test methods and test strategies, development and execution of formal protocols, analysis and interpretation of results, and communication of results and their impact through written reports, design reviews, and interactive discussions
- Work closely with systems engineers, marketing, and the product development team to support the successful application of new technologies and ensure that the system design meets technical, customer, and regulatory agency requirements
- Represent the voice of the customer to product developers and assist with translating the customer needs to product requirements
- Understands and communicates the broader impact of design features, test methods, and results to the user, customer, regulator, and to the marketability of the product
- Leads projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives, and directs small to medium sized teams
- Work closely with senior management, systems engineering, marketing, and the product development team to support the successful application of new technologies and ensure that the system design meets technical, customer, and regulatory agency requirements
- Manage timelines, budgets, and resources using project management tools such as PDWare, Microsoft Project, PERT charts, and Gantt charts
- Understands and follows all procedures and processes required for work performed under Regulatory Compliance
Qualifications for validation scientist
- Prepare /revise SOPs, laboratory records and other related documentation as assigned
- Experience in clinical biomarker assay development, validation & execution in clinical trials and/or development of CDx
- Experience of developing assays in partnership with CROs and/or external IVD manufacturing partners
- A good understanding of translational and precision medicine approaches/applications in early and late stage clinical trial design, “proof-of-concept” studies
- Knowledge of cancer biology/ cancer immunology and experimental techniques
- Able to train and supervise junior scientist(s) in laboratory
4
Validation Scientist Job Description
Job Description Example
Our company is growing rapidly and is looking for a validation scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation scientist
- Research and develop novel methods on platforms that represent new technology areas
- Characterize antibodies, conduct reagent conjugations, and perform reagent qualification assays
- Conduct evaluation of manufactured products and develop fit-for-purpose assays
- Communicate project updates to internal and external clients
- Provide technical reports in the form of validation plans, reports, deviation reports, test methods and tables
- Comply with internal and customer SOP’s as required in training program
- Provide technical leadership in method transfer and training of analytical team
- Contribute to tactical and strategic marketing practices for site services
- Report the scope of the validation, including work that was conducted, tests that were developed and performed, and the results of that review and testing
- Report identified weaknesses or limitations with the model in actionable terms that the model owner can use to improve model design, performance, testing or usage
Qualifications for validation scientist
- Perform testing in accordance with SOPs and/or testing procedures
- Five years of experience in clinical biomarkers, translational research and/or CDx development in a pharmaceutical/biopharmaceutical companies
- Hands-on experience in digital PCR, NGS, ligand binding assay, flow cytometry and/or histopathology
- Familiarity with clinical biomarker assay development/qualification and experience with “-omics” technologies
- Clinical genomic lab experience and/or Experience in clinical biomarker assay optimization and transfer to CROs
- Trained in the use of statistical analysis software (JMP, Minitab, SigmaStat)
5
Validation Scientist Job Description
Job Description Example
Our innovative and growing company is hiring for a validation scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for validation scientist
- Perform annual verification activities, including CIP and CCP/OPRP verifications
- Plan and execute multiple assigned validation activities simultaneously, which may include use of PCs monitoring, laboratory work environment significant projects for new lines, new products process/facility/equipment modifications or process improvements
- In case of a deviation, evaluate results, investigate, find the root cause, eliminate/mitigate the root cause and propose some actions and validate again
- Prepare and maintain QA/Validation standard operating procedures
- Provide training and project support to validation techs and other validation support
- Assemble LC-MS systems, including required software, to perform compliance product validation
- Identify and coordinate activities required to complete qualification and validation activities, including reviews with Quality, obtaining signature approvals, and executing qualification protocols or validation project plans
- Ensure supply of high quality product through ensuring equipment availability
- Develop and implement key elements of a flexible analytic validation framework
- Facilitate and drive department peer review teams to execute analytic validation projects
Qualifications for validation scientist
- Strong understanding of scientific and operational requirement (considerations) in executing biomarker and/or CDx strategies in clinical development is required
- Strong track record of publications in clinical/translational biomarker study contribution/authorship of documents for regulatory submission
- Strong knowledge of national & international regulatory requirements and compliance
- Strong background in human immunology, excellent publication track record
- Documented experience in characterization of novel immunological phenomena
- Excellent knowledge of autoimmune pathobiology