- San Diego, CA
- Full Time
- Assay Development - 1100
Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.
To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!
Truvian is seeking a highly motivated Senior Scientist with IVD experience to join the Assay R&D team. The Scientist will be responsible for developing the design, execution, analysis and supporting of assay for V&V studies in preparation for FDA submission. They will be core collaborators as part of the Assay Development team with full cross-disciplinary team of system integration engineers, algorithm developers and technical operations engineers to ensure V&V studies meet requirements. We are seeking candidates who are collaborative, driven, and innovative, with excellent critical thinking and problem-solving skills. The candidate must have V&V experience for IVD assay development.
HERE’S WHY YOU’LL LOVE THIS JOB:
- You'll work with a rock star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products
- You’ll be a key player on a team responsible for the company’s growth and product launch
- You’ll thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
- You’ll have great perks such as: Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount
WHAT YOU WILL DO:
Broadly, this role is responsible for the V&V studies of Truvian’s diagnostic immunoassays. This will require:
- Meeting goals, objectives, priorities and tactical plan for the Immunoassay IVD development team to achieve regulatory submission
- Strong background with Bioconjugation chemistry and immunoassay development
- Ensuring robust and reproducible assay performance that satisfies product requirements via assay optimization, guard banding, specification development, stability testing, systems integration testing and troubleshooting following FDA recommended guidelines
- Collaborating with tech transfer team to ensure successful hand-off of assay, reagent scale-up and QC processes
- Preparing and presenting comprehensive technical or project reports and formal presentations to internal/ external audiences
- Overall team leadership including setting individual/team goals, ensuring employee development, providing on-going coaching and feedback, recognizing employee contributions, enabling meaningful career experiences, and creating an inclusive and safe work environment
- Contributing assay development expertise in cross-functional product development teams
- Communication of results and challenges with colleagues and senior management in a timely manner
WHAT YOU WILL BRING:
PhD in a related engineering or life science discipline with 2+ years of experience in R&D OR Masters with 4+ years’ experience OR Bachelors 10+ years of experience. Must have prior experience in industry in relevant space (rapid or point-of-care immunoassay diagnostics, in vitro/blood diagnostics). Strong Biochemistry and protein conjugation a must.
The ideal candidate will possess:
- Experience in in vitro diagnostics (IVD) V&V studies including understanding assay optimization, V&V studies, product development life cycle, risk and design control
- Strong Biochemistry and Bioconjugation chemistry is a must, in labs hands on chemistry-with focus on preparation from small to medium and large scale.
- Strong understanding of CLSI guidelines, associated with IVD testing and submission
- Achieving aggressive timelines, through a combination of superior planning, proven assessment of risk and the ability to inspire and enable others to move fast
- Partnership and collaboration, emphasizing the company and team over personal goals, and the ability to collaborate across disciplines
- Communication, both oral and written, with the ability to communicate frequently, clearly, and timely while keeping both internal and external parties aligned to deliver impact at pace
- Tools including experience implementing and working in Microsoft office and statistical tools
- Problem solving, with very strong analytical skills which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills
- Practical experience in assay integration with consumables and instrument platform
- Proven interpersonal, communication, and presentation skills; excellent time management skills
- Able to excel in collaborative, fast-paced, and evolving start up environment; able to manage competing priorities
- Ability to proactively identify issues and address with solutions-oriented approach
- Must have superb attention to details, producing work of exceptional quality and accuracy
- Ability to function well in a high-paced and at times stressful environment.
PHYSICAL DEMANDS AND ABILITIES
- Regularly required to use hands to finger, handle or feel, reach with hands and arms and talk or hear
- Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance
- Frequently required to stand, walk, stoop, kneel, crouch or crawl
- Occasionally required to sit and climb or balance
- Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus
If you want to stand out, please include a cover letter
Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.