Senior Director, CMC Analytical Development - Gene Therapy

Jobtailor; Philadelphia (Philadelphia County); On-site; USD 150,000 - 210,000; Full time

Job summary

Jobtailor in Philadelphia seeks an experienced analytical leader to oversee external analytical development within the CMC organization for gene therapy programs.

You will manage activities at CDMOs and external labs, ensuring timelines, quality, and scientific standards, while providing oversight on method development, qualification, validation, transfer, and troubleshooting across multiple modalities (AAV, DNA, RNA, LNP).

Qualifications

• 10+ years hands-on experience with gene therapy product development
• Experience managing outsourced analytical activities through CDMOs and external laboratories
• Experience supporting drug product development across early and late clinical phases
• Direct experience authoring regulatory documents (INDs, IMPDs, BLAs)
• Strong expertise in analytical method qualification and validation in GMP environments
• Knowledge of analytical requirements for gene therapy modalities (AAV/DNA/RNA/LNP)
• US work authorization (citizenship or work visa)

Responsibilities

• Lead and oversee external analytical development within the CMC organization for gene therapy programs
• Manage analytical activities performed at CDMOs and external testing laboratories, ensuring timelines, quality, and scientific standards
• Provide scientific oversight for analytical method development, qualification, validation, transfer, and troubleshooting activities
• Support analytical strategies for drug substance and drug product development from early clinical stages through late-phase development
• Create and approve Certificates of Analysis for sponsor-owned Drug Substance, Drug Product, and Starting Materials
• Author, review, and approve analytical protocols, reports, specifications, method validation packages, and stability data generated by external partners
• Drive analytical readiness for regulatory submissions including IND, IMPD, BLA, and MAA filings
• Collaborate closely with Manufacturing, Quality, Regulatory Affairs, and external partners to ensure alignment of CMC objectives
• Support analytical investigations, deviations, OOS/OOT assessments, comparability studies, and change controls
• Contribute to selection, onboarding, governance, and performance management of CDMOs and analytical service providers
• Ensure all outsourced analytical activities comply with GMP and applicable regulatory expectations
• Act as the internal analytical SME for modalities including AAV, DNA, RNA, and LNPs

Skills

Analytical Method Development

Regulatory Submissions (IND, IMPD, BLA

GMP Compliance

Gene Therapy Product Development

Stakeholder Management

Education

Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmaceutical Sciences, or related field

Job description

Jobtailor in Philadelphia seeks an experienced analytical leader to oversee external analytical development within the CMC organization for gene therapy programs.

You will manage activities at CDMOs and external labs, ensuring timelines, quality, and scientific standards, while providing oversight on method development, qualification, validation, transfer, and troubleshooting across multiple modalities (AAV, DNA, RNA, LNP).