Senior QC Scientist - Viral Vectors & Assays

Candel Therapeutics, Inc.; Needham, Northern (MA, KY); Hybrid; USD 155,000 - 160,000; Full time

Job summary

Candel Therapeutics, Inc. in Needham, MA seeks a Senior Scientist I, Quality Control to execute complex analytical assays supporting clinical and commercial programs. The role collaborates with external manufacturing for tech transfer and focuses on Adenovirus and Herpesvirus vectors.

You will perform cell-based assays (ELISA, HPLC, qPCR, SDS-PAGE, UV-Vis), generate data, document in ELN, and help develop/validate new assays. US work authorization is required; no sponsorship offered.

Qualifications

• Hands-on QC in biotech/pharma with GxP regime.
• Experience with Drug Substance/Product release and stability testing in a GxP environment.
• Experience with analytical method development/qualification/transfer into QC.
• Strong knowledge of GxP principles and ICH guidance.
• Hands-on experience with analytical techniques such as HPLC, ELISA, qPCR, electrophoresis, cell-based assays, virus quantification/potency assays, and UV/Vis.
• Experience authoring SOPs and analytical methods and transfer protocols.
• Hands-on experience with mammalian cell culture and viruses (Vero/HEK293).
• Ability to work independently in a small, fast-paced biotech environment.

Responsibilities

• Participate in development of cell culture and viral vector production.
• Function as 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 data in paper or ELN.
• Participate in development, optimization, and validation of new assays.
• Assist with SOPs and batch records for QC or external CMOs.
• Interact with Analytical Development, QA, Regulatory, Research, Upstream and Downstream Process Development.
• Contribute to laboratory support duties in QC laboratory.
• Guide, direct, and train direct reports and team members.
• Able to react to change productively and handle other essential tasks.

Skills

Quality Control

GxP/GMP

Analytical methods

Cell culture

Virus work

qPCR

HPLC

ELISA

SDS-PAGE

Data management

Education

PhD in biology/biochemistry/chemistry

Tools

HPLC

qPCR

ELISA

SDS-PAGE

Vero/HEK293

Viral vector assays

Job description

Candel Therapeutics, Inc. in Needham, MA seeks a Senior Scientist I, Quality Control to execute complex analytical assays supporting clinical and commercial programs. The role collaborates with external manufacturing for tech transfer and focuses on Adenovirus and Herpesvirus vectors.

You will perform cell-based assays (ELISA, HPLC, qPCR, SDS-PAGE, UV-Vis), generate data, document in ELN, and help develop/validate new assays. US work authorization is required; no sponsorship offered.