Senior Scientist I, Quality Control

Essential Areas of Responsibility

• Participate in the development of cell culture and viral vector production using Adenovirus and Herpesvirus production systems.
• Function as subject matter expert (SME) for technical platforms and new methodologies.
• Perform assays in support of process development including cell-based assays, ELISA, HPLC, qPCR, SDS-PAGE, UV-spectroscopy.
• Generate, manage, evaluate, and maintain critical data in a highly organized manner and document in paper or Electronic Laboratory notebook.
• Participate in the development, optimization, and validation of new assays.
• Absorb, learn, and adapt to new methods, drug development processes, new modalities, etc.
• Guide, direct, and train direct reports and team members, including performance monitoring, constructive feedback, quality standards, etc.

Minimum Education, Experience and Skill Requirements

• Education: PhD or equivalent in biology, chemistry, biochemistry, or related field plus applicable experience.
• Experience: Hands-on experience with aseptic techniques related to mammalian cell culture (Vero and HEK293 cells lines), hands-on experience in laboratory techniques supporting virus, protein and DNA analysis: SDS-PAGE, Western Blot, BCA, residual DNA, HPLC, ELISA, willingness to learn, previous experience in small biotech/pharma company, previous experience working with viruses, ability to work independently, familiarity with basic regulatory expectations around product control strategies and the ICH guidelines for method qualification, familiarity with Drug Substance and Drug Product release and stability testing programs, a strong background in one or more analytical techniques such as various HPLC based methods, microplate UV/Vis/Luminescent assays, cell-based assays including virus quantification and potency, qPCR, electrophoresis, sizing techniques such as DLS, ability to write technical documents, including but not limited to method SOPs, development reports, qualification reports, method transfer protocols and method transfer report, functional understanding of GxP principles, strong computer skills and good verbal and written communication skills, very good collaboration and team building skills.