Product Development Scientist II

Geneoscopy, Inc.•Maryland Heights, MO

6d•Onsite

About The Position

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.

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.
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.

Nice To Haves

Direct experience in Next-Generation Sequencing (NGS) workflows including RNA extraction, library preparation, hybrid capture, and sequencing.

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.