Associate Scientist, Analytical Development
Cabaletta Bio
August 19, 2026
On-site
Philadelphia, PA
Operations
Position Summary
Reporting to Director, Analytical Development, this experienced and motivated Associate Scientist will join Analytical Development Team to support lifecycle method management, including method development and qualification and analytical testing support for projects at Process Development and CDMOs, plus CDMO testing oversight (assay performance trending, troubleshooting/root cause analysis) for pre-clinical and clinical programs. Collaborate with CMC, Quality & Compliance, Supply Chain, and external partners.
Responsibilities
- Participate in development, optimization, and qualification/validation of analytical methods to evaluate safety, purity, identity, potency of lentiviral vectors, cell therapy product, and other advanced modalities in compliance with regulatory guidelines.
- Perform analytical testing supporting method development and qualification.
- Provide technical oversight and serve as SME to CDMOs and external labs.
- Monitor/trend assay performance; investigate deviations, out-of-specification, out-of-trend, and out-of-expectation results.
- Provide analytical expertise to Process Development, MSAT, Quality & Compliance, and Quality Control.
- Author/review method protocols, reports, and supporting documentation to ensure GMP/GDP and regulatory compliance.
- Present in technical meetings and drive resolution of analytical-related issues.
Qualifications
- Bachelor’s or master’s degree in biology or closely related discipline; 2–4 years of experience.
- Proficient in aseptic techniques for cell culture and cell-based assays.
- Strong analytic experience (flow cytometry, qPCR/dPCR, ELISA, HPLC, etc.).
- Experience with analytical method qualification and validation.
- Experience with CDMOs/contract testing labs in biologics, cell, and gene therapy.
- Familiarity with GMP compliance.
- Strong problem-solving, communication/interpersonal skills, attention to detail, organizational skills, and ability to manage multiple priorities.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew
Reporting to Director, Analytical Development, this experienced and motivated Associate Scientist will join Analytical Development Team to support lifecycle method management, including method development and qualification and analytical testing support for projects at Process Development and CDMOs, plus CDMO testing oversight (assay performance trending, troubleshooting/root cause analysis) for pre-clinical and clinical programs. Collaborate with CMC, Quality & Compliance, Supply Chain, and external partners.
Responsibilities
- Participate in development, optimization, and qualification/validation of analytical methods to evaluate safety, purity, identity, potency of lentiviral vectors, cell therapy product, and other advanced modalities in compliance with regulatory guidelines.
- Perform analytical testing supporting method development and qualification.
- Provide technical oversight and serve as SME to CDMOs and external labs.
- Monitor/trend assay performance; investigate deviations, out-of-specification, out-of-trend, and out-of-expectation results.
- Provide analytical expertise to Process Development, MSAT, Quality & Compliance, and Quality Control.
- Author/review method protocols, reports, and supporting documentation to ensure GMP/GDP and regulatory compliance.
- Present in technical meetings and drive resolution of analytical-related issues.
Qualifications
- Bachelor’s or master’s degree in biology or closely related discipline; 2–4 years of experience.
- Proficient in aseptic techniques for cell culture and cell-based assays.
- Strong analytic experience (flow cytometry, qPCR/dPCR, ELISA, HPLC, etc.).
- Experience with analytical method qualification and validation.
- Experience with CDMOs/contract testing labs in biologics, cell, and gene therapy.
- Familiarity with GMP compliance.
- Strong problem-solving, communication/interpersonal skills, attention to detail, organizational skills, and ability to manage multiple priorities.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew