Senior Scientist I, Quality Control

Job Description

Job Description

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. 

Minimum Education, Experience and Skill Requirements: 

Education: 

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

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 (new methods, drug development processes, new modalities, etc.) and ability to demonstrate scientific curiosity and innovation. 

• 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, etc.  

• 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. 

Must be authorized to work in the US. No sponsorships available.

We are not accepting resumes from agencies at this time. 

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