Provide executive level management for all activities and facilities involved in the technology transfer and scale-up to production and cGMP and GMP manufacturing and packaging of clinical therapeutic products produced from cultured genetically-modified mammalian cells.
Requires 10+ years experience in scale-up and manufacturing and technical expertise in biochemical engineering and bioprocessing related to monoclonal antibodies; recombinant proteins; gene vectors; and live virus.
Areas of ...
Shall manage all activities and facilities involved in the technical scale-up and cGMP manufacturing of: monoclonal antibodies; recombinant proteins; gene vectors; live viral vaccines and cultured genetically-modified mammalian cells.
Requires track record in the scale-up and cGMP manufacturing of biologics and some expertise in biochemical engineering and bioprocessing.
Highly visible career growth position at international company with history of stability and growth in healthcare's cutting ...
Contact Larry at 815-756-1221 for more details.
- BS -PhD Chemistry, Physical Science, Plant biology or Breeding
- 10+ years in a leadership role
- 5+ years in delivering scalable solutions for field applications
- Familiar with pathogen detection, environmental testing, remote imaging and/or soil analytics
- Project management skills
- US Citizen/Perm Resident
Will lead a team of Engineers and Biologists to understand environmental aspects impacting agriculture.
We are a Santa Barbara based recruiting firm seeking a Field Application Scientist for our client who develops and manufactures industry leading imaging equipment for customers in pharma, biotech, academia and government. With excellent leadership and strong financial backing, our client offers exceptional career growth opportunities, and a friendly community-oriented culture. The role includes overnight travel (approximately 60-80% peak times).
Location: This position may be based anywhere in the ...
Lead development of a companion diagnostics for novel cancer antibody therapy.
Requires experience with developing immunoassays, biomarker profiling studies, and mechanism of action analysis, for diagnostic-driven combination therapies.
*** Develop assays.
*** Design experiments.
*** Analyze and interpret experimental data.
*** Report results.
*** Author sections of regulatory filings
*** MD or Ph.D. in a biological discipline.
*** Expertise in Next Gen ...
Director of Regulatory Affairs - CMC
Global leader in the development and production of life saving pharmaceuticals seeks a Director of Regulatory Affairs - CMC to oversee a large regulatory affairs group working on chemistry and manufacturing controls throughout the company. This highly regarded company offers excellent career growth opportunities across its many divisions, both domestic and international. The Director of Regulatory Affairs - CMC will:
Be responsible for all ANDA submissions ...
Reporting to the Manager R&D, work as part of the PLZ R&D team. Duties will include formulation of new to business and CARB compliant products, performance evaluation, raw material selection and qualification, sales sample preparation, and technology transfer.
With guidance from the Manager of R&D, plan & develop new and robust formulations and manufacturing processes.
When required due to regulation change or opportunity, reformulate
products and ...
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