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Scientist, Product Development

Cambridge, MA
Scientist, Product Development
Sherlock Biosciences, an exciting new diagnostic company based on next-generation CRISPR and Synthetic Biology technology platforms. We are creating a new generation of biology-based molecular diagnostics that can rapidly deliver accurate and inexpensive results in any setting. Our goal is to address unmet diagnostic testing needs in infectious disease, oncology, agriculture and other areas to transform public health. Successful candidates will join an exciting, collaborative and fast-paced company focused on improving human health worldwide.   

Summary/objective 
This role is integral to the successful achievement of assay and product development objectives. The Scientist will also contribute to partnering activities with internal departments and external contractors to drive innovation and product development. This role will drive continuous improvement within product development processes and manage resources to achieve results on time and within budget. Successful candidates will join an exciting and fast-paced team focused on improving human health worldwide through highly innovative CRISPR and Synthetic Biology-based platforms for molecular diagnostics. 

Essential functions
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
  • Plan and execute research and development activities and contribute to new product success
  • Help drive the innovation of the platform and translate improvements into new products
  • Conduct feasibility studies and develop reagents within design control process and oversee validations 
  • Conduct and oversee research and development of new products, as well as the transfer of products to Operations 
  • Conduct investigations and analyses to troubleshoot and enhance existing methods, improving assay capabilities and technical robustness
  • Establish and validate performance parameters, quality control, and stability specifications for critical reagents
  • Ensure successful integration of assay to consumable device 
  • Manage assay-device integration and performance
  • Manage deliverables in the development and commercialization of reagent applications and new product development.
  • Work independently and manage multiple projects simultaneously
  • Ability to critically analyze and present data, clearly communicate findings to management and multidisciplinary groups
  • Author method qualification/validation protocols/reports, sample testing plans, bioanalytical reports, and test methods
  • Direct analytical studies for FDA approval and ensure GMP, ISO and IVDD compliant documentation.
Competencies
  • Experience and knowledge in Synthetic Biology, DNA nanotechnology or nucleic acid structure, design and amplification
  • A strong theoretical and practical knowledge of a wide variety of biological assays (PCR, immune- and enzymatic-based assays) and how material interactions can impact those assays
  • Practical testing and applications understanding in a manufacturing or R&D environment
  • Strong experience in the development and implementation of complex clinical assays and experience with assay product integration
Supervisory responsibilities
  • None
Work environment
  • Laboratory
Physical demands
  • Long periods of standing or sitting
Travel required
  • None.
Required education and experience
  • Ph.D. in Bioengineering or Life Sciences with a minimum of 1 years of industry experience, or M.S. in Bioengineering or Life Sciences with minimum of 4 years industry experience
  • Demonstrated accomplishments in assay development under design controls
  • Demonstrated knowledge of cell and molecular biology, pathology, and biochemistry with technical aptitude to learn different scientific applications quickly
  • Ability to deliver in a fast-paced, team-oriented environment
  • Strong background in assay development, including nucleic acid manipulation and detection
  • Excellent leadership and communication skills, creative problem solver in technical areas
Preferred education and experience
  • Experience in IVD product development and FDA submissions
  • Experience integrating assay chemistry into a consumable device a plus
  • Management experience a plus
Additional eligibility requirements
  • None
Work authorization/security clearance requirements
Authorized to work in the United States 
 
The ideal candidate will be prepared to BE GREAT!

Boldness - We will push boundaries and confidently confront any challenge.
Excellence - We will be our best and help our team members be their best.

Growth  - We will support each other to advance our careers and achieve our personal goals.
Respect - We care about ourselves and each other, behaving honestly and with integrity.
Equity - We will build a diverse and inclusive team which treats each other as we expect to be treated.
Accountability - We expect the team and hold each other responsible to meet our obligations.
Trust  - We will be open in our communications and support anyone acting on our core values.
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