client is seeking a Director – R&D for Reagents!
client specializes in diagnostic IVD Point-of-Care instruments in blood
management and hemostasis testing. The company holds an excellent employee
retention rate and offers competitive salaries and bonus structures. And this
position allows for expansion and upward mobility in the future- perhaps even
R&D Director must have experience in Hemostasis or blood-related IVD field.
They will work with a team to plan, design and conduct complex and advanced
experimentation, design and formulate IVD reagents and assays for POC
instruments. The R&D Director will have good experience in design control
and product development of new products as well as supporting existing
- Scientific lead
or contributor to projects (research, development, control, analysis) for
product discovery, development, launch and support
investigations of on-market product issues; meet specific investigation
and program objectives
- Plan, design and
perform complex experiments and preparations in the laboratory; adhere to
safety policies and procedures
compile and analyze data; prepare reports and present suggestions and
recommendations to management
- Develop details
and lead approach assignments with consideration of schedule, cost,
reliability, simplicity, manufacturing methods and effectiveness
cross-functionally and with external contacts; attend and lead meetings as
- Participate in
planning, leading and defining new systems, processes and/or methods
- Mentor R&D
team members. Supervise direct reports in the lab in the execution, design
and interpretation of experiments.
in-depth knowledge of the field of hemostasis and coagulation; keep
abreast of new developments.
- Lead scientific
discussions both internally and externally; contribute to scientific
publications in peer-reviewed journals, external conferences and/or
scientific patents where applicable.
- Ensure and
maintain compliance with the Company’s quality system requirements through
training and adherence to policies, procedures and processes
degree and relevant postgraduate degree and training (Ph.D. required) in
IVD and the area of coagulation.
- Minimum of 10
years previous medical/in vitro diagnostic research experience required
development experience in Hemostasis or blood-related IVD field preferred.
Prior experience in an industrial laboratory setting required and
experience with coagulation reagents and instrumentation a plus.
knowledge of design control processes and familiarity with GMP required.
investigative ability and analytical skills is a must
- Expertise in
designing and conducting experiments with antibodies, coagulation proteins,
platelets, peptides and enzymes is required
- Must possess an
understanding of physical and chemical parameters of proteins and lipids;
knowledge of the stabilization and optimization of activities of proteins
and enzymes as required
technical writing and documentation, communication, interpersonal,
analytical, and presentation skills are essential
literacy required; knowledge of Microsoft Office (including extensive
Excel skills) and significant management systems required
- Must be flexible
- Must be
self-motivated and have the ability to work with minimal supervision; must
also be able to work as part of a cross-functional team.