Senior Scientist I, Quality Control

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

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.

Preferred

• 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.

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