Senior Scientist Of Bioanalysis
We are a clinical-stage biopharmaceutical company that discovers and develops novel products for the treatment of cancer. The current opening offers an opportunity to lead efforts around probody bioanalysis in a fast moving r&d environment.
the successful candidate will:
- serve as a company-wide resource in the area of large molecule bioanalysis
- work closely with project teams to identify and address needs for pharmacokinetic and immunogenicity (including neutralizing antibody) analysis
- select and manage vendors providing contract bioanalytical services
- oversee bioanalytical method development, validation and sample analysis
- innovate as necessary to meet specialized programmatic needs
- troubleshoot assay performance and sample testing as needed
- review bioanalytical study protocols and reports for completeness and regulatory compliance
- provide guidance in development of nonclinical and clinical study protocols
- train / mentor research staff and oversee wet lab activities in house
- phd, or pharm.D. In pharmaceutical sciences or a related field
- 5-8+ years relevant industry experience supporting both preclinical activities and clinical trials
- experience in quantitative bioanalysis of large molecules using ligand binding, chromatographic, mass spectrometric, or other analytical technologies
- experience with immunogenicity analysis in clinical and preclinical setting
- knowledge of current glp regulations, applicable guidance documents and white papers.
- prior experience working in a regulated glp compliant environment
- excellent communication skills and experience in working with multidisciplinary teams+undefined Other Responses
Clinical Laboratory Operations
Laboratory director of operations
the laboratory services provide for a diverse range of simple to highly complex routine and esoteric assays supported by a broad base of technologies including ria, elisa, cell based assays, colorimetric assays, pcr, cell culture, hplc and spectroscopy. In this role you will be responsible for all activities in the laboratory including but not limited to:
- setting direction and allocating resources to assure that the laboratory meets the production requirements while maintaining a quality level that meets regulatory requirements.
- assuring that all facets of people, equipment, documentation and procedures are compliant to all required regulatory agencies.
- recruiting, training, reviewing and mentoring lab employees
- working with the laboratory director, senior management, clinical r&d, quality assurance, sales, finance and other departments as required.
- investigating employee incidents and accidents, communicating these problems to the laboratory director and senior management as required.
- taking an active role in dealing with employee suggestions, complaints and grievances.
- coordinating with lab supervisor(s) in setting performance standards for clinical laboratory personnel.
- working with staff and management to plan and formulate clinical goals and objectives.
- ensuring completion of deliverables and adherence to timelines; track milestones and timelines across projects and institute necessary work flow, personnel and financial resource allocations, making alterations when necessary to meet expectations of clients
- analyzing and resolving issues that have the potential to jeopardize performance and/or ability to meet agreed upon deliverables; analyze financial and operational reports.
- analyzing trends, developing and maintaining a program for organizational learning and sharing of experiences, internally and externally.
- developing programs to improve laboratory efficiency and reduce costs.
- managing laboratory documentation
- maintaining familiarity with the laboratory information system (lis)
- participates as an active member of the clinical laboratory staff to improve the overall efficiency of the laboratory
- participates in planning sessions and coordinates training of technologists with the technical supervisor to improve the performance of the clinical laboratory.
position requires a phd and national certification (ascp) as a medical technologist or clinical laboratory scientist. Minimum of 5-7 years as a laboratory manager/director managing a cro central lab or a bioanalytical lab performing highly complex assays. Experience with the following technologies elisa, pcr, and/or hplc. Strong computer skills and the ability to work in a flexible environment and adapt easily to change in direction.+5 Other Responses