Team Lead – Assay Development

We are Vital. We build products that combine cutting-edge science and intuitive design in ways that make measuring health and taking action accessible by everyone. Our mission is to democratize technology that puts people in control of their health.

About Our Team:

At Vital, we thrive on change, operate on trust, and leverage the diversity of perspectives from a global team in everything we do. We operate at a rapid pace and we push key decisions to folks on the front lines across the organization. Our culture is fundamentally rooted in having a growth mindset - which means at Vital you will make an impact; your talent and energy will make a difference, and your life’s best work will be possible. As a workplace, we challenge and support you to hone your craft and be a part of something bigger than any of us.

Vital is seeking a passionate and creative scientist to fill the role of Team Lead, Assay Development. The Team Lead will be experienced with taking a product to market in the medical device/diagnostics space, specifically someone who’s familiar with the verification and validation and FDA process. The ideal candidate is strategic and operational and will ensure that Vital’s assays are robust and can be run properly. S/he is comfortable motivating his/her team and proficient in the planning and execution of experiments, maintaining equipment, preparing high-quality reagents and buffers, and performing various molecular biology and biochemistry laboratory techniques. As the resident expert for assay development, s/he will enjoy playing a critical role in a fast-paced lab environment and does not shy away from bench work to troubleshoot and optimize Vital’s next-generation assays. The ideal candidate is eager to actively contribute to Vital’s product development direction and present novel procedural and scientific concepts that will positively impact all aspects of the Vital ecosystem.

What you’ll do:

• Provide leadership and mentorship to the assay development team, who are excited about disrupting the medical diagnostics space with Vital’s innovations

• Oversee and develop, optimize and validate new assays for Vital’s diagnostic product pipeline 

• Manage assay development resources and resolve any conflicts

• Design, execute, troubleshoot and meticulously document experiments

• Quantitatively analyze flow cytometry and microscopy data and communicate results to fellow scientists and non-science members of the team

• Analyze clinical samples for assay verification and validation

• Tap into various resources to support experimental design

• Help the team develop and achieve goals to meet ambitious timelines

• Construct, modify, and follow standard operating procedures in direct collaboration with the development team

• Transfer methods to other internal or external partners and support collaborations through defensible result production and QC procedures

• Author, review, and hone Vital’s standard operating procedures (SOPs) to improve quality and accelerate Vital’s assay pipeline

• Be actively involved in laboratory management including inventory management and supply chain responsibilities

• Partner closely to provide assay development support to Vital’s research, manufacturing science, downstream formulation, and engineering teams to achieve performance requirements

• Communicate effectively with peers and leadership to support decision-making, including summarizing results in reports and presentations

• Contribute to departmental strategies and provide input on lab requirements and improvements

• Manage multiple tasks and changing priorities in a fast-paced environment

What you need:

• Ph.D. or Masters in a life science discipline (Biochemistry/Biotechnology) with 5+ years of industry experience

• 3+ years of experience in regulated medical device development with strong knowledge of FDA, Health Canada and European regulatory requirements

• Strong knowledge of design elements to meet IVD regulatory requirements for CLIA waiver

• Excellent knowledge of CLSI guidelines and their appropriate interpretation to design studies for regulatory clearance of Vital Systems

• Competency in design and  development of immunochemistry and biochemical assays

• Hands-on experience and demonstrated track record in diagnostics assay development

• Prior experience in taking a product to market in the medical device/diagnostics space, with  verification and validation and FDA process experience

• Familiarity with the medical device industry and associated regulatory pathways

• Experience with execution of experiments in a wet lab preferably in an industry setting

• Demonstrated success in managing resources and leading scientific / technical teams with an emphasis on building a high performance culture and supporting direct reports’ growth and development

• Experience with FlowJo, FACS Diva, or other flow cytometry analysis platforms

• Experience working with laboratory automation/liquid handling (i.e., TECAN)

• Ability to write and maintain standard operating procedures

• Assay development experience with clinical samples

• Strong problem solving and troubleshooting skills

• Ability to communicate results and concepts clearly to fellow scientists and direct reports

• Excellent organization, time-management, record-keeping, interpersonal and communication skills

• Must be able to work and contribute to a highly collaborative and fluid environment on multiple, diverse projects concurrently

• High learning agility

• GMP experience will be considered an asset

• Prior experience working in a fast-paced, start-up environment is strongly preferred

• Preferred but not required: a hearty appreciation of puns!

The Rewards

• An opportunity to change the face of medical diagnostics 

• Working with a high-functioning, deeply motivated team 

• A competitive compensation package 

• An environment where one can showcase their talent and know that his/her contributions, thoughts, ideas and expertise are valued every day

About Vital

Vital is revolutionizing the landscape of point-of-care diagnostics with our groundbreaking platform, VitalOne, designed to deliver real-time care wherever patients are. We have built a dynamic team of experts across various disciplines including chemistry, software, engineering, and microfluidics to fulfill our mission of making healthcare more accessible and proactive. At Vital, we seek tenacious, bold, and enthusiastic individuals ready to create impactful change in the healthcare industry.