Director of IVD Assay Development
Company DescriptionAt Biomeme we make things. We make hardware; we work with biological organisms. We're looking for passionate people who are skilled with their hands and have impeccable attention to detail. You should be a fast learner and not afraid of tackling challenges both big and small. No task is above or below your pay grade.Biomeme is as interdisciplinary as it gets. We combine rigorous biology and chemistry with best-in-class hardware and software engineering. It's all wrapped up in sublime user design, with the goal of helping our customers enact real-world change.
Guided by data and a belief in the iterative process, we develop elegant solutions to complex problems that demand precision. Join our team and be a part of a collaborative, innovative environment where your contributions are valued, and your work makes a direct impact on improving patient outcomes. We offer excellent opportunities for professional growth and development in a field that’s at the forefront of medical technology.
Location
Center City, Philadelphia, PA 19108
Employment Type
Full Time - Exempt
Experience and Qualifications
A PhD or MS in Molecular Biology, Biochemistry, Biotechnology, or a related discipline, with a strong focus on in vitro molecular diagnostics and assay development. A minimum of 10 years of experience in IVD assay development, including at least 5 years in a leadership capacity. Demonstrated track record of successful assay development from concept to commercialization.
Job Description
We are seeking an accomplished Director of IVD Assay Development to lead the design, development, and validation of innovative in vitro diagnostic (IVD) assays, with a particular emphasis on molecular host response assays that leverage our proprietary isothermal amplification technology. This role is pivotal in advancing our research and development initiatives, ensuring that our products meet stringent regulatory standards and address unmet clinical needs. The ideal candidate will demonstrate a combination of technical acumen, strategic vision, and leadership capabilities to guide projects from inception through commercialization.The Director of IVD Assay Development will work closely with cross-functional teams, including R&D, Quality, Regulatory, Clinical, Manufacturing, and Commercial, to ensure a seamless transition of assays from development to market.
This role demands a strategic leader with deep expertise in assay development and a proven track record of successfully launching products in the diagnostics domain.To be successful in this role, you will need to have a strong attention to detail, excellent written and communication skills, and the ability to work collaboratively with cross-functional teams. We offer a dynamic and collaborative work environment, with opportunities for growth and development. If you have a passion for product development and are excited to join a team dedicated to improving patient outcomes through in vitro diagnostic products, we encourage you to apply.
Responsibilities
- Lead the Development Team: Oversee and mentor a multidisciplinary team of scientists and research associates. Provide technical direction, foster career development, and ensure high performance. Cultivate a culture of innovation, accountability, and scientific excellence. Create and maintain development milestones and deliverables to ensure projects are completed on time and within budget. Prioritizing product and customer requirements, determination of product specifications and working with the broader research and development (biology, software, engineering) teams to define and deliver solutions. Apply Design for Six Sigma (DFSS) tools and techniques to design and optimize product and processes, to achieve statistically driven results, ensuring they meet customer requirements and quality standards.
- Product Development Activities: Drive the optimization, design of experiments, determination of specifications, and design transfer to manufacturing for advanced diagnostic assays. Lead the planning and execution of analytical verification studies to ensure assay robustness and clinical applicability. Guide development utilizing our proprietary isothermal amplification technology to develop molecular host response assays that meet stringent performance criteria and clinical requirements.
- Regulatory Compliance: Work collaboratively with quality and regulatory to ensure all assays meet applicable regulatory standards, including compliance with FDA QSR , EU IVDR, ISO 13485, and other international requirements. Prepare, review, and oversee technical documentation to support regulatory submissions, such as design history files, technical files, and analytical verification reports.
- Cross-Functional Collaboration: Serve as a critical interface with Executive Leadership, Engineering R&D, Quality Assurance, Clinical, Regulatory Affairs, Manufacturing, and Commercial teams to align assay development activities with overarching business objectives. Facilitate effective communication to resolve technical challenges and ensure alignment across departments. Collaborate with sales, marketing, and support teams to ensure that products are successfully launched and promoted.
- Customer and Market Focus: Engage with key opinion leaders, clinicians, and other stakeholders to identify market needs and ensure the development of assays that meet customer expectations. Represent the company at scientific conferences and present research findings to enhance the company’s thought leadership within the diagnostics community.
- Strategic Planning: Define and drive the strategic vision for IVD assay development, including establishing product development roadmaps, prioritizing projects, and identifying novel opportunities for innovation. Stay abreast of emerging trends and technologies to maintain the company's leadership in the diagnostics field.
- Resource Management: Manage departmental budgets and resource allocation to ensure efficient project execution. Develop project timelines, track progress, and make necessary adjustments to meet milestones and deadlines. Ensure optimal utilization of resources and proactively address technical or logistical challenges. Occasional travel to attend conferences.
Requirements
- Educational Background: PhD or MS in Molecular Biology, Biochemistry, Biotechnology, or a related discipline, with a strong focus on molecular diagnostics and assay development. Several years of product management experience, including experience leading cross-functional teams to develop and launch products.
- Industry Experience: A minimum of 10 years of experience in IVD assay development, including at least 5 years in a leadership capacity. Demonstrated track record of successful assay development from concept to commercialization. Strong analytical and problem-solving skills: must be able to analyze data and metrics to inform product direction and priorities and must be able to identify and solve problems that arise during the product development process. Must have an understanding of Design Controls.
- Team Leadership: Proven experience in managing and leading cross-functional teams in the diagnostics or life sciences industry. Ability to inspire, mentor, and build high-performing teams.
- Ability to Prioritize: must be able to prioritize competing demands and make decisions about which tasks and projects to focus on first.
- Regulatory Expertise: Comprehensive understanding of regulatory pathways for IVD products, including FDA, CE mark, and ISO 13485 standards. Experience in preparing technical documentation for regulatory submissions. Demonstrated working knowledge of ISO 14971 standard for Risk Management in Medical Devices. Ability to identify potential hazards associated with medical devices, assess their risks, and implement appropriate control measures. Experience conducting Failure Mode and Effects Analysis (FMEA) to systematically evaluate potential failure modes and their impact on device performance and safety.
- Technical Skills: Extensive experience in molecular biology techniques, including nucleic acid amplification, hybridization, and detection methodologies. Strong background in isothermal amplification technologies and molecular host response assays. Demonstrated expertise in experimental design, statistical analysis and data interpretation methodologies to guide development through analytical verification.
- Advanced Diagnostics Expertise: Experience in the development of multiplex assays, point-of-care diagnostics, or companion diagnostics. Experience with isothermal molecular amplification assay design and development, including optimization of reaction conditions, assay sensitivity and specificity analysis, and troubleshooting complex technical challenges.
- Communication and Project Management: Exceptional communication, leadership, and project management skills. Proven ability to manage multiple projects concurrently and deliver results within established timelines and budgets.
- Product Lifecycle Management: Experience across the entire product lifecycle, from concept and feasibility through design, verification, validation, and commercialization. Ability to collaborate with manufacturing teams to ensure assay scalability and successful technology transfer.
- US Work Eligibility
Preferred
- Biomarkers and Clinical Knowledge: In-depth knowledge of biomarkers, molecular diagnostics, and the clinical implications of assay results. Experience with clinical sample handling and understanding of pre-analytical variables that influence assay performance.
