Assistant Director Operations (Code: S-28) HistoRx
The Assistant Director, Operations is primarily responsible for providing the regular oversight of Operations groups at HistoRx.
Reporting to the Senior Director, Operations, this includes defining project scope and methods, resource allocation, employee supervision and communication of results. Scientific projects will follow Good Laboratory Practices and/or Good Clinical Practices. This person will also oversee product development efforts in support of existing projects and initiatives.
- Management of multiple projects: Resource allocations and adherence to timelines
- Projects and initiatives can span the following areas:
o Manufacturing Operations and Manufacturing Support
o Assay Development, Production, Distribution and Sustaining Engineering
o Software Development, Production, Distribution and Sustaining Engineering
- Coordinated analysis services, in support of:
o Pharma Operations
o FDA/Diagnostic initiatives/Clinical Trial work
o Other development initiatives
o Coordinate operations support for external initiatives (e.g. platform integration, licensing, technology transfer)
- Other Projects as Assigned
- Requires a PhD in a scientific discipline
- Minimum of 10 years experience in a scientific environment
- Demonstrated expertise in analytical methods and statistical analysis
- Experience with FDA QSR regulated medical device operations desired
- Familiarity with CLIA regulated laboratory operations a plus.
||300 George Street |
New Haven, CT 06511