Senior Scientist I, Quality Control
Candel Therapeutics
August 31, 2026
On-site
Needham, MA
Operations
Senior Scientist I, Quality Control is responsible for executing highly complex analytical assays supporting clinical and commercial programs. The role collaborates with external manufacturing and tech transfer, focusing on Adenovirus and Herpesvirus vectors and associated cell-based potency assays, including training technical staff and troubleshooting/validating new and established assays.
Essential Areas of Responsibility:
- Develop cell culture and viral vector production using Adenovirus and Herpesvirus systems.
- Serve as subject matter expert (SME) for technical platforms and new methodologies.
- Perform process development assays: cell-based assays, ELISA, HPLC, qPCR, SDS-PAGE, UV-spectroscopy.
- Generate, manage, evaluate, and maintain critical data; document in paper or Electronic Laboratory Notebook.
- Develop, optimize, and validate new assays.
- Assist in developing SOPs and batch records for QC and/or external CMOs.
- Coordinate with Analytical Development, Quality Assurance, Regulatory Affairs, Research, Upstream/Downstream Process Development.
- Support QC laboratory operations.
- Guide, direct, and train team members (performance monitoring, feedback, quality standards).
- Handle other assigned essential tasks; react productively to change.
Education/Qualifications:
- PhD (or equivalent) in biology, chemistry, biochemistry, or related field plus applicable experience (internship/post-doc accepted).
- Hands-on QC experience in biotech/pharma.
- Experience supporting Drug Substance/Drug Product release and stability testing in GxP/GMP.
- Analytical method development/qualification/validation and transfer into QC.
- Strong knowledge of GxP principles, regulatory expectations, and ICH guidance.
- Hands-on analytical techniques: HPLC, ELISA, qPCR, electrophoresis, cell-based assays, virus quantification/potency assays, and/or UV/Vis/luminescent assays.
- Author technical documentation (SOPs, methods, development/qualification reports, transfer protocols/reports).
- Mammalian cell culture and viruses (ideally Vero and/or HEK293).
- Independent, effective work in a small, fast-paced biotech environment.
Preferred:
- Viral vector/oncolytic virus/biologics/advanced therapy experience.
- Cross-functional experience (Analytical Development, QC, QA, Manufacturing).
- Support methods across the development-to-QC lifecycle.
Application instructions/eligibility:
- Must be authorized to work in the US; no sponsorships available. No agency resumes are being accepted at this time.
Essential Areas of Responsibility:
- Develop cell culture and viral vector production using Adenovirus and Herpesvirus systems.
- Serve as subject matter expert (SME) for technical platforms and new methodologies.
- Perform process development assays: cell-based assays, ELISA, HPLC, qPCR, SDS-PAGE, UV-spectroscopy.
- Generate, manage, evaluate, and maintain critical data; document in paper or Electronic Laboratory Notebook.
- Develop, optimize, and validate new assays.
- Assist in developing SOPs and batch records for QC and/or external CMOs.
- Coordinate with Analytical Development, Quality Assurance, Regulatory Affairs, Research, Upstream/Downstream Process Development.
- Support QC laboratory operations.
- Guide, direct, and train team members (performance monitoring, feedback, quality standards).
- Handle other assigned essential tasks; react productively to change.
Education/Qualifications:
- PhD (or equivalent) in biology, chemistry, biochemistry, or related field plus applicable experience (internship/post-doc accepted).
- Hands-on QC experience in biotech/pharma.
- Experience supporting Drug Substance/Drug Product release and stability testing in GxP/GMP.
- Analytical method development/qualification/validation and transfer into QC.
- Strong knowledge of GxP principles, regulatory expectations, and ICH guidance.
- Hands-on analytical techniques: HPLC, ELISA, qPCR, electrophoresis, cell-based assays, virus quantification/potency assays, and/or UV/Vis/luminescent assays.
- Author technical documentation (SOPs, methods, development/qualification reports, transfer protocols/reports).
- Mammalian cell culture and viruses (ideally Vero and/or HEK293).
- Independent, effective work in a small, fast-paced biotech environment.
Preferred:
- Viral vector/oncolytic virus/biologics/advanced therapy experience.
- Cross-functional experience (Analytical Development, QC, QA, Manufacturing).
- Support methods across the development-to-QC lifecycle.
Application instructions/eligibility:
- Must be authorized to work in the US; no sponsorships available. No agency resumes are being accepted at this time.