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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in analytical method development, qualification, and validation within GMP environments, specifically for gene therapy products. Proven ability to manage outsourced analytical activities and ensure compliance with regulatory standards while collaborating effectively with cross-functional teams.
Highest-signal resume keywords
Analytical Method DevelopmentGene Therapy Product DevelopmentRegulatory Submissions (IND, IMPD, BLA)GMP ComplianceStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Analytical ChemistryBiochemistryBiotechnologyMolecular BiologyPharmaceutical SciencesAnalytical Method QualificationAnalytical Method ValidationRegulatory Document AuthoringTroubleshootingChange Control
Soft Skills
Attention to DetailProactiveAccountableStrong CommunicationStakeholder Management
Industry Keywords
Gene TherapyAAVDNARNALNPCDMO ManagementGMPRegulatory AffairsAnalytical InvestigationsClinical Phases
About the role
Key responsibilities & impact- 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
What you’ll need- 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)
- Candidates located in the Philadelphia region or willing to travel to and work in Philadelphia for one week each month
Benefits
Comp & perks- Opportunity to help develop breakthrough therapies for patients with serious vision-threatening diseases
- Work alongside a passionate, highly experienced team at the forefront of ophthalmology innovation
- Meaningful impact in a growing biotech company
- Collaborative, entrepreneurial culture where science and innovation drive decision-making