Associate Scientist, Analytical Development – On-site, Philadelphia, PA : Tell Me More

Cabaletta Bio; Philadelphia (Philadelphia County); On-site; USD 85,000 - 110,000; Full time

Job summary

Cabaletta Bio is seeking an Associate Scientist, Analytical Development, to join the on-site team in Philadelphia, PA. You will help develop, qualify, and validate analytical methods for cell therapy products and work closely with CDMOs and internal partners.

The role requires strong aseptic techniques, experience with flow cytometry, qPCR/dPCR, ELISA, and HPLC, and a solid GMP/regulated environment mindset. Excellent problem-solving and communication skills are essential.

Qualifications

• Bachelor’s or master’s degree in biology or related discipline with 2–4 years of experience.
• Proficient in aseptic techniques for cell culture and cell-based assays.
• Strong experience with analytical techniques including flow cytometry, qPCR/dPCR, ELISA, HPLC.
• Demonstrated experience with analytical method qualification and validation.
• Experience working with CDMOs and contract testing laboratories in biologics, cell and gene therapy fields.
• Familiar with GMP compliance.
• Demonstrated scientific problem-solving, analytical thinking, and communication/interpersonal skills, with ability to manage multiple priorities.

Responsibilities

• Develop, optimize, and qualify/validate analytical methods to evaluate safety, purity, identity, and potency of lentiviral vectors and related products.
• Perform analytical testing in support of method development and qualification activities.
• Provide SME input to CDMOs and external laboratories and monitor assay performance.
• Monitor assay performance, investigate deviations and out-of-spec results at internal and external partners.
• Provide analytical expertise to Process Development, MSAT, Quality & Compliance, and Quality Control.

Skills

Aseptic techniques

Flow cytometry

qPCR/dPCR

ELISA

HPLC

Method qualification

Method validation

GMP compliance

CDMOs collaboration

Contract testing labs

Communication

Problem-solving

Education

Bachelor’s or Master’s degree in biology or closely related discipline

Tools

Flow cytometer

PCR instruments

HPLC system

ELISA reader

Job description

Associate Scientist, Analytical Development – On-site, Philadelphia, PA

About the Position

Reporting to Director, Analytical Development, this experienced and motivated Associate Scientist will join Analytical Development Team, participating in a variety of analytical activities involved in lifecycle method management - method development and qualification, analytical testing support for projects at Process Development and CDMOs, CDMO testing oversight (assay performance trending, troubleshooting/root cause analysis) for pre-clinical and clinical programs.

The successful candidate has opportunities to collaborate closely with CMC, Quality & Compliance, Supply Chain, and external partners.

Responsibilities Include

• Participate in the development, optimization, and qualification/validation of analytical methods, as required to evaluate safety, purity, identity, potency of lentiviral vectors, cell therapy product and other advanced modalities, in compliance with relevant regulatory guidelines
• Perform analytical testing, supporting method development and qualification activities.
• Participate in technical oversight and serve as subject matter expert (SME) to CDMOs and external laboratories.
• Assist monitoring/trending of assay performance, investigation of assay deviations, out-of-specification, out-of-trend and out-of-expectation results at Analytical Development and external partners.
• Provide analytical expertise to Process Development, Manufacturing Sciences and Technology (MSAT), Quality & Compliance, and Quality Control
• Author and review method protocols, reports, and supporting documentation, ensuring compliance with GMP, GDP, and applicable regulatory requirements.
• Present in technical meetings and drive resolution of analytical-related issues.

Required Qualifications

• Bachelor’s or master’s degree in biology or closely related discipline with 2-4 years of experience.
• Proficient in aseptic techniques for cell culture and cell-based assays.
• Strong experience in analytic techniques, including flow cytometry, qPCR/dPCR, ELISA, HPLC etc.
• Demonstrated experience with analytical method qualification and validation.
• Experience working with CDMOs and contract testing laboratories in biologics, cell and gene therapy fields.
• Familiar with GMP compliance.
• Demonstrated scientific problem-solving, critical-thinking, and communication/ interpersonal skills, with attention to detail and strong organizational skills, and ability to manage multiple priorities in a fast‑paced environment. external laboratories.
• Assist monitoring/trending of assay performance, investigation of assay deviations, out-of-specification, out-of-trend and out-of-expectation results at Analytical Development and external partners.
• Provide analytical expertise to Process Development, Manufacturing Sciences and Technology (MSAT), Quality & Compliance, and Quality Control
• Author and review method protocols, reports, and supporting documentation, ensuring compliance with GMP, GDP, and applicable regulatory requirements.
• Present in technical meetings and drive resolution of analytical-related issues.

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.