Oakwood Laboratories Quality Control Microbiology Department is searching for a Microbiologist.
Oakwood Labs is a privately owned specialty pharmaceutical company focused on the design, development, and commercial manufacture of sterile injectable sustained-release microsphere products. This unique class of medications delivers therapeutic levels of drug to patients over days, weeks, months, or a year with a single intramuscular or subcutaneous injection. Products of this class have extremely high commercial potential. We offer a competitive benefits and salary package.
Under the direct supervision of the Microbiology Laboratory management the Microbiologist is responsible for:
- Environmental monitoring of ISO classified rooms and personnel monitoring (gown and glove sites).
- Must be able to pass gown certification requirements to access the aseptic core.
- Microbiology testing of utility systems (compressed gas and water systems).
- Testing:
- Raw Materials (bioburden by membrane filtration and/or plate count method),
- Drug Product samples (IP/PF bioburden by membrane filtration and/or plate count method, bacterial endotoxin kinetic chromogenic method),
- Stability samples (bacterial endotoxin kinetic chromogenic method.
We are seeking individuals with:
- Bachelor of Science (B.S.) degree in Microbiology or Biological Science and/or at least Bachelor of Arts (B. A.) degree in Life Science with a minimum of two years of experience in a GMP laboratory environment or equivalent
- Experience with sterile aseptic techniques for laboratory and clean room practices
- Microbiology testing knowledge (membrane filtration and plate count methods)
- Prior experience using Microsoft Word and Excel
- GMP and/or GLP training is preferred.
- Remain current with regulatory requirements and emerging industry trends.