Research and Development Operations Manager:
Gainesville, Florida (On-site)
As Research and Development Operations Manager, you will provide daily lab supervision, operations support and leadership in the design, implementation and execution of Research & Development strategies. Such as coordination of laboratory product design verification and validation studies - to ensure proper compliance to legally market the organizations products both domestically and internationally.
Core Responsibilities:
- Planning, scheduling, creating, and carrying out studies to verify and validate product designs, including composing protocols and reports.
- Administers the scheduling and planning of the research and assay development laboratories. Participate in meetings when planning, strategy-setting, status reports, and other activities are discussed for projects or tests.
- Maintain close communication with the technical team, academic institutions, and business partners to make sure the company is at the forefront of biotechnology and nanotechnology research, development, and commercialization.
- Add scientific expertise to the process of developing new products and help with technical communications for the business.
- Help clients, sales, marketing organizations understand technical data.
- Create primer probes that target conserved sections of the genome for bacterial and viral pathogens - to aid in the creation of new products.
- Create, direct, and manage the Research & Development team, including work and responsibility distribution - while providing prompt and efficient performance evaluation of staff. This involves making sure that all actions are taken in accordance with the Company's rules, any relevant regulatory policies, and any applicable legal requirements.
- Arrange meetings and interactions with external partners to ensure the organization's requirements for accuracy and quality are upheld.
- Uphold regulations & requirements by governing bodies including but not limited to FDA, ISO, IVDR, MDCG, and CMDCAS.
- Support the quality management system (QMS) and review quality system documents as applicable.
- Perform other duties as required or assigned to enable effective functioning of the R&D department.
- Identify and establish technical procedures needed to consistently execute technical processes and ensure continuous compliance.
Education & Experience Requirements:
- B.S. or above degree in a Life Science, Molecular Biology or related discipline.
- Minimum 2 or more years in vitro laboratory experience.
- 4+ years' experience of in vitro diagnostic (preferred) device development or clinical laboratory testing.
- 2+ years' experience in a supervisory/management position.
- Experience and expertise writing, and/or reviewing, verification & validation and/or lab specification documents.
- Working knowledge of GLP requirements, FDA regulations, vendor-sponsor best practices, and is capable of supporting infrastructure evaluation and improvement.
- Strong interpersonal skills - ability to communicate clearly with a variety of people and personalities.
- Expert level project management, data analysis, time management skills to ensure efficient execution consistently.
