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QC-Lead / Analytical Chemist-IV

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Company :
Nano Precision Medical

Location :
Emeryville, California

Expiry Date :
Fri, 26 Mar 2021 23:59:59 GMT

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Description :
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 its slightly larger than a grain of rice!
Opportunity
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. 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. Youll 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, 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 include RP-HPLC and occasional SEC analysis, 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.)
* May mentor junior team members

Requirements

* Bachelor’s Degree in chemistry, analytical chemistry or equivalent discipline
* Minimum of 5 years in the pharmaceutical industry or pharmaceutical contract lab environment.
* Minimum of 3 years of experience with QC analysis and QC review, including significant experience at the GMP level
* Minimum of 3 years of experience with reverse phase HPLC
* Excellent wet lab skills
* Manage multiple fast-paced projects
* Thrive in team environment
* Creative problem solving
* Strong attention to detail
* Excellent communication and documentation skills
* Legally eligible to work in the US

Preferred Qualifications

* Proficiency with Chromeleon software

Benefits

* Competitive salary with equity
* Competitive benefits
* 401(k) matching