Analytical Chemist

Reva Medical LLC•San Diego, CA

14d

About The Position

We are a growing pharmaceutical/medical device company specializing in polymer-based drug delivery systems actively seeking an experienced Analytical Chemist to join our Quality Control team.

Requirements

BS in Chemistry (or closely related field) with a minimum of 3 years (preferably 5+ years) of hands-on analytical experience in the pharmaceutical or medical device industry. An equivalent combination of education and experience will be considered.
Proven expertise operating and interpreting data from HPLC, NMR, and Karl-Fischer instrumentation.
Working knowledge of cGMP, ISO 13485, and pharmaceutical analytical procedures.
Excellent attention to detail, documentation practices (GLP/GMP), and technical writing skills.
Strong teamwork and communication abilities.
Ability to stand or sit for extended periods, lift up to 25 lbs, and perform close-vision/microscope work.

Nice To Haves

Experience with GPC/SEC and GC-MS is highly desired.
Familiarity with ChemStation, Empower, or OmniSec chromatography data systems is a strong plus.
Prior experience analyzing polymers or macromolecules is highly advantageous.

Responsibilities

Independently perform analytical testing on polymers, monomers, raw materials, and finished drug products using HPLC, GPC/SEC, GC-MS, Karl-Fischer titration, and flow-through dissolution systems.
Conduct incoming inspection of raw chemical materials per established specifications and procedures.
Develop, validate, and execute test methods as needed.
Manage and coordinate internal and external analytical testing, including stability studies for polymer devices and drug products.
Generate Certificates of Analysis (CoA), product release documentation, and technical summary reports.
Provide analytical support to Quality Assurance and Manufacturing teams.
Maintain laboratory equipment, order supplies, ensure proper housekeeping, and oversee safe chemical waste disposal in compliance with safety standards.
Perform additional tasks as required to support company objectives.