Product Development Scientist II
This is an onsite, in-office position at Geneoscopy HQ in St. Louis, Missouri.
The
Product Development Scientist II is responsible for providing a critical technical role in the research and development of all In-Vitro Diagnostic (IVD) products at Geneoscopy. This role requires a results-focused, team-oriented scientist capable of acting as the technical lead for development and validation programs, and independently designing experiments, leading validation studies, troubleshooting complex technical issues, and supporting clinical launch.
RESPONSIBILITIES- Design, oversee, and execute, when needed, robust assay development and optimization studies for Geneoscopy's IVD product pipeline.
- Lead analytical and clinical validation activities, establishing comprehensive validation protocols.
- Assign development projects, coordinate timelines, and ensure deliverables are met on schedule while maintaining accountability for project success and results.
- Define critical assay specifications and performance requirements to ensure product quality and regulatory alignment.
- Diagnose the root cause of advanced technical issues and recommend data-driven technical solutions to product development challenges or alternative development strategies.
- Manage external research collaborations relevant to the program.
- Serve as an internal and external technical expert for molecular biology techniques, providing cross-functional support to multiple projects and participating directly in customer/partner discussions.
- Analyze, distill, and present complex technical findings, milestones, and data to cross-functional teams and stakeholders.
- Contribute actively to scientific and strategy discussions with minimal technical input from management.
- Write technical reports and manuscripts of completed projects for publication in scientific journals, or for presenting to regulatory agencies or at conferences, or use in further research activities.
- Write, update, and approve Standard Operating Procedures (SOPs) to maintain standard laboratory compliance.
- Support CAP/CLIA documentation requirements and ensure the laboratory remains in an audit-ready state.
- Manage and mentor a small team of junior scientists and research associates, acting as a lead or first-level supervisor and promoting best laboratory practices and ensuring compliance with the quality systems.
- Oversee the training of research associates, onboarding activities, and provide direct coaching and mentorship to junior personnel to guide them through the assay development process.
- Review and sign off on experimental plans and raw data generated by junior staff members to ensure scientific integrity.
- Assist leadership with laboratory workload prioritization and resource allocation to meet project timelines.
- Perform work with minimal supervision and a high degree of latitude: 40% lab, 30% analysis, 20% reporting, 20% management/mentoring, and 10% external.
- Navigate complex issues and problems.
- Exemplify expert knowledge of the subject matter.
- Other duties as assigned.
EDUCATION REQUIREMENTS- Possess a Ph.D. in Molecular Biology, Biochemistry, Genetics, or related scientific discipline with 6+ years of hands-on laboratory experience, experiment conducting, and data collection, OR
- Possess a Master's degree in a relevant scientific discipline with 7+ years of experience, OR
- Possess a Bachelor's degree in a relevant scientific discipline with 10+ years of experience.
QUALIFICATIONS- Demonstrate strong proficiency in advanced experimental design, including statistical approaches and establishing clear acceptance criteria.
- Demonstrate expertise in structured root cause analysis and ability to navigate, troubleshoot, and correct routine and non-routine technical issues independently.
- Exemplify advanced capability in scientific data interpretation, translating complex sequencing metrics into actionable development strategies.
- Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.
- Possess proficient verbal and written communication skills while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.
- Possess high ethics and conduct business in the most professional manner.
- Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.
- Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.
- Possess a strong commitment to people development, with a demonstrated ability to mentor, train, and guide junior Scientists and Research Associates.
- Preferred Additional Experience:
- Direct experience in Next-Generation Sequencing (NGS) workflows including RNA extraction, library preparation, hybrid capture, and sequencing.
SCHEDULEThis is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.
COMPENSATION & BENEFITS- Base salary range: annually determined based on the candidate's experience, knowledge, and abilities.
- Bonus: discretionary annual bonus based on a percentage of the employee's base salary
- Benefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.
- Company stock options
Physical Demands- Employees may be required to lift routine office supplies and use standard office equipment.
- Must possess the ability to sit and/or stand for long periods.
- Must possess the ability to perform repetitive motion.
Work Environment- May have exposure to fumes and bio-hazardous material in the laboratory environment.
- May be required to handle blood-borne pathogens and general laboratory reagents.