Director, Product Development

Meridian Bioscience is a fully integrated life sciences company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral, urinary and respiratory infections.

 

Our DIRECTOR OF PRODUCT DEVELOPMENT directs and manages the Product Development Department for development of new and improved in vitro diagnostic products. Accept the timely transfer of new and improved products from Research, and then direct the timely transfer to Manufacturing, Quality Control, and Regulatory Affairs. Assist Marketing with the introduction and technical support of product. Responsible for administrative duties pertaining to the Department as a whole and the preparation and monitoring of departmental fiscal year budget.

DUTIES:
Direct and manage a group of scientists to develop new and improved in vitro diagnostic products.
Establish product and development schedules and coordinate the timely progress of products through all phases of development and transfer.
Maintain awareness of current advances in clinical diagnostic technology and literature regarding immunology and biochemical methods to evaluate the prospects of developing new or improved products.
Write GMP documents related to product manufacturing and quality assurance, SOP's, MSDS, 510(k), and SBIR or other grant applications.
Prepare departmental budget, perform itemized cost accounting, and establish equipment and manpower needs (personnel time allocation) to provide for product development.
Establish initial outside clinical trial sites for all products originating in R&D.
Assist the Regulatory Affairs Department with necessary product submissions (e.g. 510(k), PMA, etc.) and response to appropriate government agencies.
Interact with Marketing and Production Departments to define new product specifications, design assay configurations, and assist Marketing product introduction and initial technical support of product.
Interact with staff in R&D, Marketing, QA, Regulatory Affairs, Manufacturing and Personnel departments.
Interact with FDA, Clinical trial investigators, patent attorneys, manufacturers, and research scientists at other industries or universities.
Participates in and adheres to the Quality Program as defined by the QSr especially as it pertains to Design Control.
Any other duties deemed necessary by management.

EDUCATION AND EXPERIENCE:

Ph.D., BS, or MS in Microbiology or related field
Minimum of five to eight years in vitro diagnostic product development experience.

SKILLS AND ABILITIES:

Experience in technical writing skills: 510(k); GMP documents (Master Device Records, Device History Records, SOP's); research reports/proposals; package inserts and publication manuscripts/abstracts; grant proposals; Gantt/tracking charts, etc.
Knowledge of technical skills includes: Antigen/antibody purification, animal immunizations, monoclonal Ab generation production and purification, covalent chemistries for Ag's and Ab's, latex and EIA technologies, gel and blot electrophoresis, molecular separation methods, spectroscopic methods, immunochemical characterization of proteins, bacterial and cell culture.
Ability to communicate with scientists in other disciplines, including biochemistry and immunology.
Good management skills with ability to supervise all levels of research staff.
Good understanding of research scheduling and reporting procedures.

 

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.