Senior Scientist, CMC Analytical Development

JOB SUMMARY

The Senior Scientist in CMC Analytical Development will serve as a scientific and strategic contributor in the development, optimization, and validation of analytical methods supporting AAV-based gene therapies. This individual will lead key analytical activities, mentor junior staff, and drive technical execution across Splice Bio's programs. The successful candidate will collaborate closely with cross-functional teams, including Process Development, Quality Control, and Regulatory Affairs, to ensure analytical readiness for development milestones, technology transfer, and regulatory submissions.

KEY RESPONSIBILITIES

• Lead the development, optimization, and validation of analytical methods for characterization of AAV vectors, including potency, purity, identity, and safety assays.
• Independently design studies, analyze results, and propose strategic next steps to improve assay robustness and performance.
• Serve as a technical expert for troubleshooting complex analytical and assay issues.
• Evaluate and implement emerging analytical technologies to advance AAV product characterization.
• Perform and oversee routine and non-routine analytical testing to support development, comparability, stability, and manufacturing activities.
• Effectively manage and mentor junior scientists and technicians, including daily task planning and technical guidance.
• Ensure laboratory activities meet internal quality standards.
• Collaborate with Process Development and Manufacturing to keep analytical methods consistent with updates to AAV production processes.
• Support analytical sections of regulatory submissions, including IND/IMPD modules, method validation reports, and comparability data packages.
• Lead method transfer activities to CROs and CDMOs, including protocol authoring, training, and troubleshooting.
• Manage analytical work packages executed at CROs/CDMOs, including oversight of timelines, deliverables, method execution, and data review.
• Ensure external partners adhere to quality and regulatory expectations.
• Author and review high-quality technical documentation, including protocols, method development reports, validation/qualification reports, and SOPs.
• Maintain accurate and detailed electronic laboratory notebooks and data records.
• Contribute to the development of internal best practices, workflows, and quality systems.

REQUIRED QUALIFICATIONS

• Education:
  Ph.D. in Biotechnology, Biochemistry, Molecular Biology, Analytical Chemistry, or related field with 4+ years of relevant experience; M.S. with 7+ years, or B.S. with 10+ years experience in analytical development or related roles.
• Direct hands-on experience with analytical characterization of viral vectors, preferably AAV.

Skills and competencies:

• Proficiency with cell culture (suspension and adherent), cell-based potency assays, and viral transduction.
• Strong experience with key analytical platforms such as qPCR, dPCR, ELISA, Western blot, flow cytometry, HPLC/UPLC, capillary electrophoresis, and other viral vector assays.
• Experience with bioassay development and statistical tools, including DoE and assay qualification/validation.
• Understanding of analytical validation and GMP expectations; direct validation experience preferred.
• Knowledge of AAV manufacturing processes (upstream/downstream, purification, release testing) is strongly preferred
• Demonstrated ability to lead junior team members, provide scientific mentoring, and manage laboratory workflows.
• Experience managing external partners (CROs/CDMOs) and ensuring delivery of high-quality analytical data.
• Excellent problem-solving, time management, and project leadership skills.
• Strong written and verbal communication skills, including experience presenting to multidisciplinary teams and contributing to regulatory documentation.
• Ability to manage multiple projects and adapt in a fast-paced, evolving environment.