The Director R&D, Product Development is responsible for the scientific aspects of product development and validation, the management of the product development R&D organization, and ensuring all stages of product development are conducted in compliance with DNA Genotek quality procedures.
- Project oversight and management of cross-functional deliverables and timelines.
- Responsible for managing the design and execution of product development, validation testing and analysis of results.
- Responsible for ensuring product development and validation activities are conducted according to DNA Genotek quality procedures and applicable regulations.
- Responsible for Design Transfer to manufacturing
- Manages staff of lab technologists, research associates and scientists utilizing DNA Genotek performance management system and good general management / leadership practices.
- Works with Product Management, Project Management, Physical Design, Intellectual Property, Regulatory, Quality, and Research teams and other staff towards the complete and integrated development of saleable products.
- Oversees and prepares experimental design for experiments.
- Communicates study plans and outcomes to the DNA Genotek executive team.
- Provides scientific guidance and support to staff members and all departments within DNA Genotek.
- Ensures that priorities and deliverables are in alignment with DNA Genotek objectives.
- Responsibility for content of scientific reports.
- Provides product/technical support.
- Prepares written protocols, white papers, and scientific papers, as applicable.
- Regularly reviews scientific literature in areas of interest to the company and takes part in appropriate scientific conferences and trade shows.
- Ensures smooth general operation of laboratory infrastructure (e.g. equipment, ordering/stocking of supplies)
- Responsible for all laboratory registration, including biosafety.
- Performs hands-on laboratory experimental work.
- May assist in the preparation of patents and/or regulatory submissions arising from DNA Genotek research activities.
- Other duties deemed appropriate for a Director R&D, Product Development.
- Demonstrated experience leading research and development functions
- Proven track record of successful product development in life science, genomics and/or molecular diagnostic companies as evidenced by commercial success.
- Demonstrable technical skill and experience in the design and optimization of molecular assays, NGS applications, sample preparation, automation methodologies and microbiological techniques.
- Significant experience in Design Control systems for product development and significant experience and understanding of FDA, EU and other global regulations and processes as applicable to new product development.
- Demonstrated writing skills through publications, patents and grant writing within their field of expertise.
- Strong people and project management skills.
- Expertise with nucleic acid chemistry and metabolites is desired.
- Familiar with principles of biological sample preservation.
- Familiar with Design of Experiments process.
- Proficient in troubleshooting experimental results.
- Experience interacting with customers and presenting at conferences.
- Strong project management, analytical and planning skills.
- Proficiency in MS Office applications
- Demonstrated aptitude towards effective management of people
- Excellent verbal and written communication skills
EDUCATION AND/OR EXPERIENCE:
- Ph.D. with specialization in Chemistry, Biochemistry, Molecular Biology, Microbiology, Biology, Genetics or other related degree or equivalent combination of relevant job experience and training.
- 7+ years experience in industry R&D, or relevant experience
- Demonstrated expertise in nucleic acid chemistry, nucleic acid extraction methodologies, and biological sample stabilization technologies, and experience working with nucleic acids (DNA/RNA/microRNA).
- Experience working with metabolites would be an asset.
- Experience in physical design and development of plastic parts desirable.
- Experience presenting scientific findings to Executives as well as external conferences.
- Experience developing IP and successful grant applications.
- Expertise in FDA regulated environment and 510(k) clearance processes.