Senior Scientist I, Quality Control

Salary $155K - $160K 
On site role in Needham

Senior Scientist I, Quality Control is 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, as well as performing training of new technical staff and troubleshooting and validation of new and established assays. The Senior Scientist I, Quality Control works with various cell lines, performs analytical methods, trends quality attributes, and suitability of product lines for continued use. 

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. 

• Assist with the development of SOPs and batch records for use in Quality Control, or external CMOs. 

• Interact with other departments such as Analytical development, Quality Assurance, Regulatory Affairs, Research, Upstream and Downstream Process Development. 

• Contribute to laboratory support duties associated with operating a QC laboratory. 

• Guide, direct, and train direct reports and team members, including performance monitoring, constructive feedback, quality standards, etc. 

• Able to react to change productively and handle other essential tasks as assigned. 

Education: 

• PhD or equivalent in biology, chemistry, biochemistry, or related field plus applicable experience. (Internship and/or post-doctoral experience is also accepted) 

Required Experience

• Hands-on experience working within or directly supporting a Quality Control (QC) function in a biotechnology or pharmaceutical environment.
• Demonstrated experience supporting Drug Substance and/or Drug Product release and stability testing in a GxP/GMP environment.
• Experience with analytical method development, qualification and/or validation, and transfer into a QC environment.
• Strong working knowledge of GxP principles and regulatory expectations for analytical methods and product control strategies, including applicable ICH guidance.
• Hands-on experience with relevant analytical techniques such as HPLC, ELISA, qPCR, electrophoresis, cell-based assays, virus quantification/potency assays, and/or UV/Vis/luminescent assays.
• Experience authoring technical documentation such as SOPs, analytical methods, development/qualification reports, and method transfer protocols and reports.
• Hands-on experience with mammalian cell culture and viruses, ideally including Vero and/or HEK293 cell lines.
• Ability to work independently and effectively in a small, fast-paced biotech environment.

• Experience supporting viral vector, oncolytic virus, biologics, or other advanced therapy products.
• Experience working cross-functionally between Analytical Development, QC, QA and Manufacturing.
• Experience supporting analytical methods across the development-to-QC lifecycle.