Product Development Manager

At Alamar Biosciences, we’re on a mission to transform the field of proteomics for the early detection of cancer and other diseases. We are creating the world’s most sensitive proteomics platform to unmask the deepest secrets of our proteome. Our fully automated, high throughput platform will empower new biomarker discoveries for early detection and prevention of common diseases. We provide exceptional opportunities for those who have the entrepreneurial spirit, enjoy developing novel technologies and products, and aspire to grow together with the company.

We are seeking a Product Development Manager with a passion for innovation to augment our novel biomarker detection and quantitation capability on Alamar’s novel technology platform. In this position, the Manager designs, implements, and executes analytical and scientific experiments to drive Product Development. Demonstrates a high degree of organization and planning and the ability to apply scientific principles to plan out and execute Validation and Verification experiments. Able to lead a group of research associates to guide them through the Product Development Process. You will be a part of a rapidly growing company to make a big impact in life science research and early disease diagnosis.

Primary Responsibilities include:

• Technical lead and responsible for providing technical expertise and leadership in product design and development planning, experimental design, experimental execution, data analysis, analytical verification and validation.
• Ensure product performance by employing proven development practices - dFMEA, DOE, guardband testing, stability/robustness testing, assessment of analytical performance, etc, following CLSI based design.
• Develop and implement quality control procedures for critical reagents and processes.
• Supervises the activities of direct reports or team members and manages execution of studies to support verification and validation of assays.
• Ensures all verification and validation studies are conducted under Good Lab Practices and maintains documentation required to meet Design Control and ISO 13485
• Works closely with biostatistics/data science groups in aligning with rationale for study designs and acceptance criteria.
• Performs basic data analysis (e.g. R, JMP, Excel).
• Communicates progress directly with colleagues and senior management.
• Due to the level of complexity of NULISA platforms and the nature of startup environments, the candidate must have excellent organizations skills, the ability to adapt quickly and eagerness to use a hands-on approach to support troubleshooting and problem solving

Requirements include:

• Ph.D. degree in Molecular Biology, Biochemistry, or relevant disciplines with a minimum of 8 years of industry experience
• 2+ years of management experience required.
• Prior experience in IVD product development highly desired
• System verification and validation [V&V] design and protocol creation
• Previous hands-on experience with Immunoassay, qPCR and/or NGS molecular assay development
• Strong familiarity with both reagents and instrument platforms and assay integration
• Self-motivation with a positive “can do” attitude and attention to details
• Strong communicator with the ability to communicate effectively within and outside of the company
• Strong organizational skills and ability to solve ambiguous problems
• Excellent project planning and management skills
• Ability to work on aggressive schedules while not sacrificing discipline and quality

The base salary range for this full-time position is $160,000 - $180,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.