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Director
Product Development
Ohio
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.
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.
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.
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