AAV CMC Consultant – Independent Contractor

Job not on LinkedIn

🔥 3 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

💼 Consultant

🦅 H1B Visa Sponsor

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👻 Ghost score 15%

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Gordian Biotechnology

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series A on 2021-11

Biotechnology • Healthcare • Pharmaceuticals

Gordian Biotechnology is a therapeutics company pioneering a novel screening platform to radically increase the efficiency of development for complex diseases of aging. The company's focus is on scaling therapeutic discovery specifically for age-related diseases.

📋 Description

• Assess current CMC readiness against the target product profile • Deliver a prioritized plan to close identified CMC gaps during the first month • Review the CDMO master services agreement and initial process development and manufacturing plan • Run regular CDMO working meetings and set agendas • Guide upstream, downstream, and analytical development • Develop a phase-appropriate potency assay strategy • Convert meetings into written next steps with owners and due dates • Track and push CDMO deliverables, timelines, and quality • Draft Module 3 for the pre-IND package and IND submissions • Ensure the CDMO's non-GMP engineering run delivers material for the GLP-tox study by six months • Prepare the CMC briefing and represent Gordian in FDA meetings • Make well-supported CMC recommendations while Gordian makes final program decisions

🎯 Requirements

• Independent CMC consultant with prior experience taking an AAV gene therapy through CMC to a first-in-human Phase 1 trial • Experience with a triple-transfection HEK293 suspension process • Experience managing external vendors, including project management, conflict resolution, and holding timelines • Written or substantially contributed to Module 3 of a pre-IND and IND application • Directly managed CDMOs for AAV manufacturing (bonus) • Taken multiple products through successful INDs and GMP batches (bonus) • Experience with analytical development in a GLP/GMP setting (bonus) • Broad fluency across CMC: process development, analytical development, drug substance, drug product, and supply chain (bonus) • Experience taking an AAV into later-phase trials or commercialization (bonus) • Experience designing large-animal IND-enabling or toxicology studies (bonus) • Sharp regulatory judgment (bonus) • Ability to work as an independent contractor under a consulting agreement • Availability for roughly 20–40 hours per week depending on project phase • Availability for occasional travel to Gordian HQ and the CDMO • Must be able to work in the United States

🏖️ Benefits

• Travel expenses are covered • Flexible hours and own schedule around CDMO meetings and milestones • Remote work • Independent consulting arrangement permitting work with other clients barring conflicts of interest

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