Scientist I
1 year contract
New Haven, CT, on-site
Pay: $42-$45/hr
Vaxxed: yes
Summary:
A dynamic pharmaceutical company is looking to bring on a Scientist with strong experience in analytical method development, separations science, and biological modalities within the bio-pharma space. This is a 1 year contract opportunity, on-site in New Haven, CT.
Key Responsibilities:
- Lead and support method transfer/validation for clinical assays
- Manage external testing and lead assay troubleshooting and OOS/OOT investigations
- Review analytical testing procedures, method performance matrix and testing results
- Author transfer related protocols for late stage clinical and commercial programs
- Provide subject matter expertise for regulatory fillings and inspections
Key Qualifications:
- D or Masters Degree, years of experience varies based on degree (1-2yrs with Ph.D, 7-10yrs with Masters)
- Experience in various biological modalities, including mAb, antibody drug conjugate, & fusion protein
- Direct hands on experience in separation science (e.g., SEC, RP, IEX), Molecular biology (PCR, DNA extraction) or immunoassay (ELISA, gel electrophoresis) techniques
- Strong hands-on experience with analytical methods especially in cGMP environments
- A sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics
- Excellent writing skills for drafting GMP documents
Next Steps:
Please contact Emily if interested or with any questions,