Senior Scientist , Quality Control

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

Senior Scientist I,Quality Controlisresponsible forexecutinghighly complex analytical assays supporting clinical and commercial programs. This position collaborates with external manufacturing and tech transfer andisfocused on Adenovirus and Herpes virus 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, performs analytical methods,trendsqualityattributes,and suitability of product linesforcontinueduse.

• Participate in the development of cell culture and viral vector production using Adenovirus and Herpes virus 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.
• 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 withoperatinga 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.

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

• 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 HEK
  293 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
  .

Must be authorized to work in the US. No sponsor ships available.