Manager, Analytical Chemistry QC
About Nano Precision Medical
Nano Precision Medical is leading the way to new approach to drug delivery! We are developing a biocompatible, miniaturized, subdermal implant with the NanoPortal TM membrane to provide long-term, substantially constant-rate delivery of therapeutic macromolecules for up to a year and it’s slightly larger than a grain of rice!
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. In addition, he or she will be managing a small team of chemists performing all QC activities for our lead product, including data analysis and QC review. 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.
- 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
- Process qualification studies for GMP-level manufacturing
- 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 department head and analytical R&D lead 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
- Execute basic operations required to keep the department running
- Ensure compliance with government rules and regulations (FDA, cGxP, OSHA, etc.)
- Mentor junior team members
- 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
- Hands-on experience with ELISA testing.
- Experience with controlled release product testing
- Proficiency with Chromeleon software
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