San Mateo Metro Area, CA
Support inhalation product development from pre-clinical stages to product approval by contributing in product manufacturing and analytical experiments.
Under general guidance, design experiments and conduct experimental work to support product development, formulation, and core knowledge of research programs.
Support GXP and R&D process development and understanding of powder formulations.
Lead equipment maintenance activities.
Able to identify aberrant data and effectively communicate observations to project management.
Effectively document experiments and results in appropriate formats.
Under general guidance, prepare technical reports, draft standard operating procedures (SOPs), change controls, GXP investigations, and/or CoAs to summarize data and document experimental conclusions.
Under limited guidance, evaluate data for trends indicative of product performance, method performance, or process performance.
Proactively communicate project status and concerns to management.
BS with 2-3+ years of pharmaceutical or biotechnology industry experience at different stages of development.
Experience with spray drying or micronization processes is a plus.
In-depth knowledge in at least one relevant field: HPLC, GC, KF moisture testing, particle size analysis, MDI/DPI performance testing.
Experience in a GMP environment is preferable.
Experience with cell based assays is preferable (cell culture, molecular biology techniques, bioassays, ELISA)
Must be able to effectively communicate verbally and through technical writing (protocol and reports).
Physical Demands & Work Environment
As part of the regular duties for this job, a candidate must:
Be able to wear respiratory protection for shifts up to the length of time prescribed by the California Occupational Safety and Health Administration.
Be able to work with various chemicals identified under California Proposition 65, once given proper protective equipment.
Have sufficient dexterity to don and doff clean room clothing over normal work attire.
Be capable of operating a computer and sitting for extended periods.
Some lifting required (not more than 50 lbs.)
Must be willing to shave facial hair if applicable for respirator use as part of lab responsibilities as needed.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.