SciPro is working with a small, innovative, late-stage biotech. They are looking for a Quality Control Scientist (level is flexible) to join their team on a 40hr/wk; 9 month contract. They are developing off-the-shelf, multimodal immunotherapies. Their programs use adenovirus constructs, and their lead asset is seeing positive phase 3 data. They are in production mode and need help in the lab producing batches of their virus.

This person will be responsible for executing highly complex analytical assays supporting clinical and commercial programs. This position collaborates with external manufacturing and tech transfer and is focused on Adenovirus and Herpesvirus vectors, associated cell-based potency assays.

Responsibilities

• participate in developing cell culture and viral vector production
• perform assays in support of PD (Cell-based assays, ELISA, HPLC, qPCR, SDS-PAGE, UV-Spectroscopy)
• maintain data in an organized manner and document in paper or electronic lab notebook
• assist with developing SOPs and batch records
• collaborate cross functionally with Analytical, QA, Reg Affairs, Research, and PD
• contribute to lab support duties associated with operating a QC lab

Requirements:

• experience with aseptic techniques related to mammalian cell culture
• experience in relevant lab techniques: SDS-PAGE, Western Blot, BCA, Residual DNA, HPLC, ELISA
• familiarity with basic regulatory expectations around product control strategies and the ICH guidelines
• Experience in GMP environment
• Excellent written and verbal communication skills

Logistics:

• 40 hr/wk; 9-month initial contract
• On-site in Needham, MA
• Flexible Schedule