Detect’s mission is to empower individuals to have greater ownership of their health with rapid, low-cost home and point-of-care diagnostics. We build breakthrough technology at the intersection of software, hardware, chemistry, and biology to make accurate diagnostics accessible at the point of need. Our ultimate goal is to apply this technology to lower costs, improve patient outcomes, and improve doctor experience by enabling earlier diagnosis and access to treatment.
Detect is a well-funded, rapidly growing health-tech company founded by award-winning scientist and highly successful serial entrepreneur, Dr. Jonathan Rothberg. Detect benefits from being a 4Catalyzer company, an incubator of biotech and med device companies who have collectively raised over $2 billion in funding.
Joining Detect is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.
Detect is offering an exciting opportunity to join our Research and Development Team, located at Detect’s main campus in Guilford, CT. We are seeking a highly skilled and experienced Principal Scientist, Biomanufacturing to develop and implement strategies for manufacturing shelf-stable biological reagents and formulated assay mixes to be packaged in diagnostic test kits. This is a leadership role that requires strong project management skills, technical expertise, and the ability to work cross-functionally and collaboratively with technical, operations, quality, regulatory, and commercial teams.
As a Principal Scientist, Biomanufacturing, you’ll have the unique opportunity to:
- Develop and maintain a comprehensive strategic plan for producing shelf-stable diagnostic test kit reagents, striving for continuous improvement on scale, quality, and cost
- Lead a lean and efficient cross-functional project team with the following responsibilities:
- Source and/or produce in-house raw material reagents (including proteins, small molecules, and other biomolecules) to support the development of high-quality in vitro diagnostic assays
- Establish and maintain an internal facility for reagent production and shelf-stable formulations
- Develop a formulation process and apply it to manufacture shelf-stable reagents at a pilot scale for use in commercially available diagnostic test kits
- Ensure the stability and quality of all raw material reagents and shelf-stable formulations in the finished product
- Direct the development and validation of biomanufacturing processes that are highly scalable and transferable for internal or external manufacturing
- Support the development and transfer of robust analytical methods and a control strategy to ensure that reagents consistently meet high quality standards
- Champion compliance with applicable regulations and requirements, including GMP, ISO, and FDA guidelines, and ensure strong documentation processes
- Act as a subject matter expert, both internally and with external partners, to resolve issues, meet production goals and timelines, and mitigate risks in our manufacturing processes
- Communicate effectively with all levels of the organization, providing regular updates on production progress, challenges, and identifying opportunities for technical innovation in the biomanufacturing space
Successful candidates will possess diversified knowledge of the principles & practices in broad areas, with technical depth in the areas indicated below. They will be effective at framing large-scale problems and balancing scientific rigor with intuition to most efficiently arrive at technical recommendations. We are looking for candidates that are self-directed – able to both work with complete independence but also develop strategic plans to organize collaborative work with others and the team they lead. Candidates will thrive if they have strong time management and scientific leadership skills. Above all, successful candidates will aspire towards a high level of personal productivity, be driven towards scientific excellence, and demonstrate a desire for continuous self-improvement and development.
- Bachelor's or Master's degree in Biology, Chemistry, Biochemistry, or related field. A Ph.D. in a relevant field is a plus
- 10+ years of experience in biomanufacturing, or 7+ years with a Ph.D., with a focus on one or more of the following areas: process chemistry, fermentation, lyophilization, and production of shelf-stable reagents for use in commercially available in vitro diagnostic assays
- Experience with commercialization of molecular diagnostic products and/or reagents
- Extensive experience with the development of robust analytical methods for use in product development and quality control
- Excellent problem-solving and analytical skills, with the ability to identify and implement solutions to complex problems. Familiarity with data analysis tools for statistical analysis is a plus
- Knowledge of relevant regulatory requirements and best practices, including GMP, ISO, and FDA regulations relevant for production of diagnostic products
- Experience reviewing and/or authoring master batch records, validation reports and other manufacturing documentation
- Experience in technology transfer with biologic-based contract manufacturers, including translating product and process requirements into specifications
- Strong leadership and management skills, with experience leading and managing lean and efficient teams
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Experience working with information management systems or related PLM software
Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!):
- Experience working in dynamic start-up environments
- Demonstrated ability to develop and implement GMP-compliant manufacturing processes and quality systems
- Experience with commercialization of molecular diagnostic products and reagents specific to isothermal amplification tests and applications
- Experience with protein fermentation, production, and/or commercialization
- Experience with regulatory requirements for the production of biological reagents for in vitro diagnostic assays
- Experience with pilot-scale QC of formulated master mixes and freeze-dried assays
- Experience with developing and implementing automation processes for biomanufacturing
You Deeply Identify with and demonstrate Detect’s Core Values:
- Put people first. Our colleagues and our customers come first. We respect each other and celebrate our diversity. We take joy in each other’s success, and succeed or fail as a team
- Eye of the owner. We have an ownership mindset and take responsibility for all of our decisions. No problem is someone else's problem. We are frugal and use company resources as if they were our own
- No genius without grit. As innovators, we fail often but fast. We are tenacious. We push through adversity and keep getting up. We are problem solvers and always find a way
- Err on the side of doing. We are scrappy and biased toward action — everyone is an individual contributor. We allow intuition to guide us when we have imperfect information
- Move fast by working smart. We are inventors. We focus, plan, pursue, and adjust to make big things happen in a fraction of the time others can. We disagree and commit
- Always be frank. We celebrate openness and diversity of opinion. We are transparent and candid but compassionate in our feedback, and are always honest to ourselves and our customers
We offer great perks:
- Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
- Competitive salaried compensation - we value our employees and show it
- Equity - we want every employee to be a stakeholder
- Pre-tax commuter benefits - we make your commute more reasonable
- Free onsite meals + kitchen stocked with snacks
- 401k plan - we facilitate your retirement goals
- Beautiful office near the ocean-front in historic Guilford, Connecticut
- The opportunity to build a revolutionary healthcare product and save millions of lives!
For this role, we provide visa assistance for qualified candidates.
Detect does not accept agency resumes.
Detect is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.