Bioanalytical Method Development And Validation
I am going to develop a bioanalytical method usinh artificial aqueous humor(nacl, kcl, cacl2, nahco3, na-lactate, na-ascorbate, glucose, urea, and albumin),so should i need to perform extraction procedure(solid phase extraction etc.) for sample preparation and internaĺ standard??please help me as early as possiboe,i am really in need!!+10 Other Responses
Senior scientist/associate director – pharmacology, this an employment opportunity in california, usa.
this new role will interact with senior management and serve as the company-wide resource in the areas of pharmacokinetics and bioanalysis.
The successful candidate will:
-participate in the design, implementation, analysis and reporting of preclinical studies generating pk or pk/pd data
-conduct modeling/simulation of pk and pk/pd data which seek to predict human efficacious dose, optimize dosing regimen, describe exposure-response and model probody activity
-provide pk(/pd) guidance in development of nonclinical and clinical study protocols
-select and manage outside labs providing contract pk or bioanalytical services
-oversee method development/validation and innovate as necessary to meet program needs for probody or pdc bioanalysis
-work closely with project scientists, toxicologists, clinical leads and multi-disciplinary teams to develop an integrated approach to probody bioanalysis and pk assessment
-contribute to the writing of study reports and organization of pk data in support of regulatory submissions
-phd, or pharm.D. In pharmaceutical sciences or a related field
-7+ years relevant industry experience supporting both preclinical activities and clinical trials; experience must include therapeutic antibodies and/or antibody-drug conjugates
-proven proficiency in the use of pk and pk/pd data analysis software, compartmental & non-compartmental data analysis as well as modeling and simulation.
-state-of-the-art knowledge of large molecule bioanalysis including pk, pd and ada assays for antibodies and adcs
-the candidate should have extensive experience in working with multidisciplinary teams, competency in developing strategy and guiding pk-based drug discovery/development decisions+9 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