Position Summary The Translational Scientist composes scientific and technical documents to support in vitro product development process activities throughout the product life cycle. The role will involve method development strategy and documentation for reagent quality control activities including writing protocols and reports and batch record creation. The Translational Scientist will work cross-functionally with Product Development and Molecular Operations teams to assist in method transfer activities and documentation. This role will also support analytical verification and validation activities including but not limited to study designs, sample requirements, protocol and report writing and will ensure those executing study protocols understand the scientific rationale. The Translational Scientist will also serve as a liaison between Product Development and Quality Assurance/Regulatory Affairs to ensure the product development process aligns with applicable regulatory requirements. The position encompasses all aspects of the product development life cycle with emphasis on in vitro diagnostics, software as a medical device, and products developed under Design Control. This position requires strong inter-personal and organizational skills. Job Responsibilities Composes technical documents throughout the product development process through collaboration with cross-functional teams including Product Development, Bioinformatics/Statisticians, Molecular Operations, QA, and RA. Author protocols and reports for QC specification setting studies. Provide assistance in compiling analytical verification and validation data to for protocol and report writing. Participate in product risk assessments. Prepare scientific and technical content for regulatory documents, pre- and post-approval, in accordance with agreed upon timeframes. Review and edit documents for product Design Reviews. Extract content from study reports and prepare new content as needed for regulatory submissions. Assist in identifying risk areas and developing alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. Assist in conducting trainings and/or communicating appropriate materials, like regulatory affairs internal policies and procedures, as needed, to enhance team’s knowledge of working in a regulated environment. Assist with regulatory compliance and the action roadmap for technical activities with the FDA and EU and other regulatory bodies to ensure Caris Life Science’s interests are reflected. Assist with ensuring diagnostic regulatory input in early stages and during clinical development to Development Team. Assist in compliance with the US FDA Code of Federal Regulations, the European in Vitro Diagnostic Directive/Regulation, EN 13485 and other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put and verification, validation, transfer and change control. Must be tolerant to change, ready to take on new challenges and open to learning new skills. Required Qualifications MS Degree with 5 years of industry experience or PhD in molecular biology, biochemistry, pharmacology, or equivalent subject matter. Preference will be given to candidates having Next Generation Sequencing experience. Previous scientific writing experience (e.g., peer-reviewed publications, validations, SOPs, etc.) Conditions of Employment: Individuals must successfully complete the pre-employment process, which includes criminal background check, drug screening, and reference verification. Preferred Qualifications Knowledge of Next Generation Sequencing Understanding of Quality Systems Regulations Multi-faceted experience in IVD and/or cGMP product development preferred. Knowledge of basic data analysis and interpretation (proficient in Microsoft Office, including Word, Power Point, Excel, Visio, Outlook, and Project Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement. Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team. Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations. Physical Demands Employee may be required to lift routine office supplies and use standard office equipment. Ability to sit for extended periods of time. Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment. Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other This position requires periodic travel and some evenings, weekends and/or holidays. Annual Hiring Range $110,000 - $122,000 Actual compensation offer to candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level. The pay ratio between base pay and target incentive (if applicable) will be finalized at offer. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Our laboratory is the heart of what we do. Learn more about our laboratory and the team of histologists who help fulfill our purpose everyday.