Senior Scientist I, Quality Control

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

SeniorScientist I,QualityControlisresponsible forexecutinghighly complexanalytical assays supportingclinical and commercial programs. This position collaborates withexternal manufacturing and tech transfer andisfocused onAdenovirus 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 Controlworkswith various cell lines, performsanalytical methods,trendsqualityattributes,and suitabilityof product linesforcontinueduse.

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, andmaintaincritical data in a highly organized manner and document in paper or Electronic Laboratory notebook.

• Participate in the development, optimization, and validation of newassays.

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

• Interact with other departments such asAnalyticaldevelopment,Quality Assurance, Regulatory Affairs, Research,Upstreamand Downstream Process Development.

• Contribute to laboratory support duties associated withoperatinga QClaboratory.

• 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 experienceis 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 supportingDrug Substance and/or Drug Product release and stability testingin a GxP/GMP environment.
• Experience withanalytical method development, qualification and/or validation, and transfer into a QC environment.
• Strong working knowledge ofGxP principles and regulatory expectations for analytical methods and product control strategies, including applicable ICH guidance.
• Hands-on experience with relevant analytical techniques such asHPLC, ELISA, qPCR, electrophoresis, cell-based assays, virus quantification/potency assays, and/or UV/Vis/luminescent assays.
• Experience authoring technical documentation such asSOPs, analytical methods, development/qualification reports, and method transfer protocols and reports.
• Hands-on experience withmammalian cell culture and viruses, ideally including Vero and/or HEK293 cell lines.
• Ability to work independently and effectively in asmall, fast-paced biotech environment.

• Experience supportingviral vector, oncolytic virus, biologics, or other advanced therapy products.
• Experience working cross-functionally betweenAnalytical Development, QC, QA and Manufacturing.
• Experience supporting analytical methods across thedevelopment-to-QC lifecycle.

Powered by JazzHR

DZURFtp29r