As a member of Mass Spectrometry and Biophysics Center of Excellence, this individual will be responsible for the design, development and hands-on execution of various biophysical and protein particulate methods to support structural characterization and comparability of biotherapeutics drug candidates at all stages of clinical development and for commercial product support.
These methods include, but are not limited to FTIR microscope, Raman microscope, Flow-based protein particulate imaging and ...
Division: Biologics - Analytical Development and Testing (ADT).
As a member of Mass Spectrometry and Biophysics Center of Excellence, this individual will be responsible for the design, development and hands-on execution of various biophysical and protein particulate methods to support structural characterization of biotherapeutics drug candidates at all stages of clinical development and for commercial product support.
These methods include, but are not limited to FTIR microscope, Raman ...
This position is accountable for bioassay development that supports a portfolio of early and late stage clinical biologics. The Associate Director will be responsible for portfolio execution in alignment with CMC development timelines.
This position reports to the Director of the Bioassay and Immunoassay Center of Excellence, within the Biologics Development organization.
This role calls for close collaboration with early discovery groups, process sciences groups, internal ...
This is a Permanent Position.
M.S. or Ph.D. in Pharmaceutics, Life Sciences, Protein Engineering or equivalent
Minimum of 10 years progressive industry experience with biologics development and at least 8 years in Regulatory Affairs
Successful track record with BLA/MAA required – direct responsibility for at least one BLA/MAA is preferred
Practical ‘hands-on” experience in handling US and/or EU registration procedures and other key countries/regions; i.e., prior ...
Direct the tech transfer and process scale up; production implementation; process and quality troubleshooting; process validations; and data collection, storage and submission for GMP and cGMP manufacture of antibodies and vaccines.
Seeking BS or MS in Engineering, Chemistry, Biochemistry, Molecular Biology, Microbiology or similar and 10 + years technical experience in a protein production, purification and aseptic fill and seal operation
*** Cell culture and bioreactor ...
As the subject matter expert for Quality Control analytical procedures the Associate Director, Global Analytical Technology is a technical expert and individual contributor that will be responsible for validation and operation of analytical methods and able to solve problems and arrive at root cause; will be knowledgeable and current with Health Authority, Pharmacopoeia, ICH, and Pharma Industry standards; knowledge of Research and Development of new drug analytics that will be transferred to Quality ...
Oct 31 -
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