Associate Director of Research & Development

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Our client is a global leader in molecular diagnostics and technology. They deliver extensive medical testing expertise, working with state-of-the-art technology and practices to deliver clients accurate and fast results. They are looking to hire an Associate Director of Research & Development to lead and oversee experimental design, assay development, and validation.

The Associate Director of Research & Development will provide guidance to a team of scientists, collaborate with various departments and company sites, and ensure the achievement of company milestones. They will also be responsible for managing project timelines, performing molecular testing, adhering to regulatory standards, and staying informed of emerging technologies.

This Role Offers:

Competitive base salary and comprehensive benefits package. Highly respected industry reputation based on innovative products and technologies. Close-knit environment with likeminded self-starters. Work alongside a team of strong technical professionals offering services to truly impact and support those making advancements within the field of medicine. Culture of integrity, high performance, and quality customer care. Team of capable, experienced, and seasoned professionals at the top of their industry; very high average employee tenure.

Focus:

Conduct experiments for developing, optimizing, verifying, and validating assays. Lead and guide a team of scientists and technical staff. Collaborate with other departments, company sites, and executive management to achieve company goals. Qualify and train on new procedures and/or equipment. Prepare and review Standard Operating Procedures (SOPs). Generate reports and relevant design-related documentation in compliance with regulations. Manage the transfer of assays and processes to other company sites and OEM suppliers. Effectively manage project timelines and milestones, keeping leadership informed of project status. Perform routine high complexity molecular testing of specimens and analyze data while adhering to safety procedures. Ensure regulatory compliance by following cGMP, OSHA, ISO 13485, and FDA requirements.

Skill Set:

6+ years of professional experience within industry/clinical lab setting. Ph.D. in Biology, Chemistry or related field. Proven experience supervising and managing staff. Skilled in molecular methodologies such as DNA extraction, polymerase chain reaction (PCR), and microarray. Prior experience with automated liquid-handling systems is desirable. In-depth knowledge of CLSI guidance documents, clinical trial design, and biostatistics. Demonstrates adeptness in laboratory tasks and organizational competencies, ensuring independent work and strict adherence to project timelines. Comprehensive grasp of Quality Systems, regulatory frameworks, and sound documentation practices. Hands-on involvement in the development and validation of IVD assays. Aptitude for effectively working in teams with diverse cultural backgrounds. Skilled in MS Office Suite. Exceptional written and oral communication skills.