Position Overview:

• The  Scientist II role is primarily responsible for performing cell-based potency assays (CBPA) of biologics for both release and stability testing in a cGMP-regulated environment. 

Key Responsibilities:

• Conduct routine cGMP testing for biologics manufacturing support.
• Prepare and review testing documentation, raw data, and laboratory logbooks/worksheets.
• Perform aseptic cell culture, cell banking, and manage critical reagents.
• Write and manage quality system records, including laboratory investigations, change controls, and non-conformances.
• Author and update standard operating procedures (SOPs).

Required Qualifications

1. Education:
• MS in Chemistry, Biochemistry, Cell Biology, or related Biological Science field with 3+ years of relevant industrial experience.
• OR BS in the same fields with 5+ years of relevant industrial experience.
2. Experience:
• cGMP-regulated environment experience is required.
• Proficiency in aseptic cell culture and 96-well format bioassays for potency testing of proteins, degradation products, and modifications.

Preferred Background:

• Candidates with experience working on cancer cell lines or human cell lines are highly preferred.
• A Ph.D. with relevant experience in GMP environments and bioassay techniques is also considered.

Pay rate:

$40/hr. - $45/hr.