Biologist

Job Description

Job Summary:

• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental/water samples, finished goods and stability samples by appropriate biochemical methods as assigned by supervisor.
• Perform routine QC responsibilities as needed.
• Apply acceptable cGMP practices during execution of all work tasks.
• Work independently with moderate supervisory guidance.

Responsibilities:

• Conduct routine and non-routine analyses of test articles as assigned by supervisor by appropriate biochemical methods such as: SDS-PAGE, HPLC, CE- SDS, ELISA, Cell Based Bioassay, etc.
• Demonstrate initiative to perform routine QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents as needed.
• Monitor laboratory equipment for temperature and conformance to specifications.
• Apply acceptable cGMP practices during execution of all work tasks.
• Work independently with minimal supervisory guidance.
• Exhibit strong teamwork skills.
• Update supervisor of progress at scheduled intervals.
• Seek additional guidance as needed.
• Use scientific expertise to provide assistance for troubleshooting, laboratory investigations audit problem resolution.
• Suggest process improvements to QC management.
• Perform assay data review.

Perform independent assignments such as:

• Compile data and prepare graphs for documentation of test procedures and preparation of reports.
• Conduct document reviews, author standard operating procedures (SOPs), and assay review.
• Lead special projects such as method validation, troubleshooting, optimization, and investigations.

Basic Requirements:

• BS requires 3-5 years and MS requires 1 -3 years of previous related experience.
• Good working knowledge of cGMP regulations is required.
• Ability to work independently with moderate supervisory guidance.
• Excellent teamwork and communication skills.
• Attentive to detail.
• Good computer skills.

Education Requirements:

• BS or MS in a related science such as a Biology 1yr or 8yr or Biochemistry is required.