Nano Precision Medical is an emerging biopharmaceutical company located in Emeryville, CA. We develop very small, sub-dermal drug implants utilizing our proprietary NanoPortal TM technology platform which enables delivery of a broad range of medicines to treat chronic diseases for durations of six months or longer. Our products, designed to address poor adherence, will significantly improve patient's lives and provide assurance to the physicians who treat them. Come join us.
The Opportunity
The Process Engineer will be responsible for developing processes for the manufacture of novel implantable drug delivery devices at bench and pilot scale. Your role will include leading experiments to characterize production processes to determine critical parameters and implement procedures appropriate for GMP production of clinical lots. Responsibilities include determining materials, packaging, and process equipment and to support commissioning/validation activities. You will support the production team to resolve technical issues and to perform formal quality investigations and identify CAPAs. As part of a cross-functional project team, you will collaborate closely with personnel in R&D, Manufacturing, QA, and Analytical groups.
To be successful in this role, you must be adept at working independently and in collaboration under a start-up environment. As part a small growing company, you must be highly effective and driven to meet objectives, while maintaining patient safety and regulatory compliance. You must have industry experience working under GMPs in the development or processing of pharmaceuticals or medical devices. Experience with device design control, DOE, aseptic processing, sterilization methods, electronics processing, or equipment qualification are highly desirable.
As a Process Engineer you will... Implement new processes for GMP manufacture of medical devices and drug formulation. Lead experiments to characterize processes and set appropriate controls. Prepare technical protocols and reports to support GMP processes. Work with vendors to design and purchase production and test equipment. Lead phase appropriate qualification activities to support GMP production. Support design control activities and establishment of design history files. Perform technology transfer of processes to CMOs. Support production activities and to resolve manufacturing and technical issues.
Requirements
A Bachelor of Science in Engineering or a related scientific field Minimum of 6 years of industry experience the field of biotech, pharmaceutical, or medical device. Direct development experience working in a GMP regulated environment. Excellent verbal and written communication skills. Legally authorized to work in the US.
Benefits
Work in a collaborative, learning environment with cutting edge technology, research and development Flexible scheduling and generous perks Medical, Dental, Vision coverage and 401k available