Sr. Scientist II, Assay Development

Biological Dynamics, Inc. is a healthcare company committed to improving global health outcomes by detecting diseases at their earliest stages. The company's proprietary platform simplifies access to native-state biomarkers and nanoparticles, enabling differentiated multiomics applications. The company is applying its platform technology along with machine learning to detect cancers in blood. For more information, please visit www.biologicaldynamics.com and follow us at @BiodynSD on Twitter.

Our talented staff thrives in an open working environment where curiosity, insights and vision are part of the equation. With an inclusive, family-friendly culture and comprehensive benefits package, we offer a terrific opportunity to discover, learn and grow. If you are ready to be inspired, challenged, and want to join a dynamic team where you can contribute to the next exciting breakthrough, we are the company for you.

JOB SUMMARY 

As part of Biological Dynamic's commitment to developing and launching cutting edge blood-based tests for detection of cancer, infectious disease, and neuropathology, we are growing the Assay Development team. This Senior Scientist II or Principal Scientist, Assay Development, is a key leadership role on the team. The candidate must be experienced in the product development process—establishing technical feasibility, development/optimization, transfer, verification, and validation. This is a hands‐on role, requiring an individual capable of designing and developing new assays utilizing our proprietary detection technology. The candidate must be able to efficiently design and execute experiments, perform appropriate statistical data analysis, and communicate results and observations effectively both as presentations and QMS-compliant documentation. This is also a supervisory role, and the candidate must have experience managing a team of RAs/Scientists. This individual must exhibit expertise in assay development in a biotech setting, excellent cross-functional communication skills, a goal-oriented mentality, and a strong sense of ownership and drive to meet project goals and timelines.

ESSENTIAL JOB DUTIES

• Serve as a technical lead for multiple projects
• Supervise and grow a team of Research Associates and Scientists, effectively planning resourcing to achieve project goals in a timely fashion
• Execute industry-standard (e.g.,Luminex) and internally-developed biochemical assays
• Effectively troubleshoot workflows and experiments on a proactive basis, taking ownership of results, interpretations, scope, strategy, and tactics on a project level
• Independently design, execute, and analyze studies, making use of immunochemistry, fluorescence/luminescence-based detection systems, appropriate statistical analyses, and other methods/tools
• Systematically optimize methods to maximize sensitivity and reproducibility
• Collaborate cross-functionally with other teams, including Research, Product Development, Engineering, Quality, and Manufacturing, in support of project objectives
• Design and develop method-appropriate calibrators and controls
• Develop new experimental approaches and discover connections between key variables
• Provide insight and strategy for achieving short- and long-term project goals
• Author QMS-compliant documentation
• Effectively communicate experimental findings at internal company meetings and in other formats as needed
• Other duties as assigned

EDUCATION/EXPERIENCE/SKILLS

• PhD in Biochemistry, Bioengineering, or related field, with a minimum of 5 years of industry experience in a development setting. Alternatively, Bachelor's or Master's degree with a minimum of 10 years of industry experience in a development setting
• Expertise in the design and development of biochemical assays
• Experience in IVD assay development highly preferred
• Expertise in the application of statistical analysis and software (e.g., JMP) to drive decision making
• Expertise in fluorescence-based detection methodologies
• Expertise in measurement system analysis, ANOVA, process control, and analytical V&V
• Experience with phase-gated PDP under design control
• Desire and drive to work in a fast-paced, hands-on entrepreneurial environment
• Expertise writing QMS-compliant SOPs, Plans, Reports
• Strong planning, organization, and prioritization skills
• Strong verbal and written communication skills
• Ability to build strong relationships and collaborations with colleagues at all levels
• Demonstrated sense of urgency and ownership regarding project deliverables

The health and well-being of our employees is of utmost importance.  As the COVID-19 cases persist, Biological Dynamics now requires proof of COVID vaccination for all employees (subject to limited exceptions) as a condition of employment beginning November 15, 2021.