Director, CMC Analytical Development

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

• 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 are achieved
• 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

Requirements

• Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmaceutical Sciences, or related field (MS/PhD preferred)
• At least 10 years of direct hands‑on experience with gene therapy product development is required
• Experience managing outsourced analytical activities through CDMOs and external laboratories
• Experience supporting drug product development across early and late clinical phases
• Direct experience authoring relevant sections of regulatory documents, including briefing packages, INDs, IMPDs and BLAs, is required
• Strong expertise in analytical method qualification and validation within regulated GMP environments
• Deep understanding of analytical requirements for gene therapy/gene editing products, including one or more of AAV, DNA, RNA or LNP
• Hands‑on scientific mindset with strong attention to detail
• Committed, proactive, and accountable
• Strong communication and stakeholder management skills
• Ability to operate effectively in a fast‑paced and evolving biotech environment
• Candidates need to be legally able to work in the US (US citizen or US work permit)

Core Competencies

Demonstrates expertise in analytical method development, qualification, and validation for gene therapy products, with a strong focus on regulatory compliance and collaboration across CMC functions. Proven ability to manage outsourced analytical activities and ensure alignment with scientific and quality standards.

Highest-signal resume keywords

• Analytical Method Development
• Regulatory Submissions (IND, IMPD, BLA, MAA)
• GMP Compliance
• Gene Therapy Product Development
• Stakeholder Management

ATS Optimization Keywords

Hard Skills

• Analytical Method Qualification
• Analytical Method Validation
• Regulatory Document Authoring
• Troubleshooting Analytical Methods
• Analytical Investigations
• Change Control Management
• Comparability Studies
• Certificates of Analysis Creation
• Drug Substance Development
• Drug Product Development

Soft Skills

• Attention to Detail
• Proactive Attitude
• Accountability
• Strong Communication
• Stakeholder Management

Industry Keywords

• Gene Therapy
• AAV
• DNA
• RNA
• LNP
• Biotechnology
• Pharmaceutical Sciences
• GMP
• CDMO Management
• Analytical Chemistry