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 qualified candidate will be an experienced hands-on analytical chemist who flourishes in a fast-paced start-up environment with shifting priorities and evolving requirements. A significant amount of time in the lab will be required. He or she will manage a small team of chemists performing all or most of the analytical support for the development of our lead product using mostly well-established test methods. It is expected that this team will perform most analyses, and will perform its own internal QC. In addition, support for new drugs in the pipeline may be involved, as well as support for development or bringing in-house of additional analytical technologies or methods.
Generally, the AC team provides ongoing analytical services to the R&D and Manufacturing teams, and also develops and transfers new analytical methods and performs one-off special investigations and projects. You’ll be part of a close-knit team of people who are focused, driven, and willing to do whatever it takes to keep the department running.
The role requires strong team orientation, flexibility, excellent communication skills, attention to detail, and creative problem solving.
Key Responsibilities/Duties
Oversee, schedule and participate in the execution of all analytical testing supporting ongoing product development using well-established analytical methods, including: Ongoing product and process optimization studies Studies supporting the completion of the Design History File for the device components. GMP-level manufacturing of clinical trial material Formal and developmental stability studies All QC review of the data generated in these tests, including GMP Collaborate closely with the other AC management team members on trouble shooting and team/project coordination Perform routine and ad-hoc activities including RP-HPLC and occasional SEC analysis, long-term dissolution testing, data processing, and QC review for ongoing product development Perform data analysis, which may include manual peak integration and identification of known degradants and potential novel impurities Investigate and resolve aberrant or unusual results Address potential equipment malfunctions and perform basic trouble shooting Execute basic operations required to keep the department running Ensure compliance with government rules and regulations (FDA, cGxP, OSHA, etc.) Mentor junior team members
Requirements
Bachelor's Degree in chemistry, analytical chemistry or equivalent discipline 10 years in the pharmaceutical industry or pharmaceutical contract lab environment. 8 years of experience with reverse phase HPLC 6 years of experience with QC analysis and QC review, including significant experience at the GMP level Several years of supervisory responsibility Excellent wet lab skills Thrive in team environment Creative problem solving Strong attention to detail Excellent communication and documentation skills Legally authorized to work in the US
Preferred Qualifications
Hands-on experience with ELISA testing. Experience with controlled release product testing Proficiency with Chromeleon software
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