AAV CMC Consultant (Independent Contractor)
准备引导 CMC 的道路，为一个普遍的与年龄有关的疾病建立的第一个基因疗法之一，从 CDMO 开启到人类中首次？旅程和目的地：戈迪安是一家治疗公司，其使命是治愈与年龄相关的疾病。我们的摩赛克查平台在活动物上进行干预，同时验证数百个目标。你可以在我们的网站和预印上阅读更多信息。引擎正在工作。我们在六个疾病领域取得了结果，并在20年内绘制了几乎所有报告的领域中的许多目标。阿诺维尔骨髓炎候选人正在 IND- 支持研究，我们开始了一项肥胖药物发现合作伙伴 Pfizer. 现在我们将首个 AAV 项目带到诊所，我们在这里做的事情将为普遍疾病的基因治疗树立先例。我们正在寻找一个 AAVCMC 专家来帮助我们的第一个基因疗法计划在人类中进行第一次，以积极的时间线。你会量身化我们的 CMC 站立的地方，与外部 CDMO 塑造我们的战略，并举行定期的工作会议，使 CDMO 保持快速发展和提供合适质量的材料，及时。你带来了专业知识和建议；戈迪安完成最后的程序电话。这是实践参与，而不是一张幻灯片上的名字。你将设定 CDMO 会议的议程，提出关于过程，分析和发布的明确建议，把每次会议都变成了清晰的下一步，并跟踪到 CDMO 交付时，推进时间表。你如何达到那里是取决于你。你会提供什么：在第一个月里，你将对我们的目标产品配置进行全面的 CMC 差距分析，并向我们提交一个优先计划来填补任何发现的差距。你还将把你的技术视角带入我们的 CDMO 主服务协议以及初步工艺开发和制造计划。在16个月内，你将进行 CDMO 工作会议，每一次都会与所有者和截止日期一起写下一步，并追逐到终点的结果。你将指导上游，下游和分析开发，包括相应的强度测试策略，并为我们的前 IND 包草案3模块，以便我们充分利用 FDA 互动。在6个月内",非 GMP 工程"CdMO 将已经提供了用于我们的 GLP 毒性研究的材料，并且你将为我们的前 IND 和 IND 提交内容编制3模块内容。
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Ready to guide the CMC path for one of the first gene therapies built for a prevalent, age-related disease, from CDMO kickoff to first-in-human?
The Journey and Destination:
Gordian is a therapeutics company whose mission is to cure age-related disease. Our Mosaic Screening platform pools interventions in living animals, giving causal validation for hundreds of targets at once. You can read more on ourwebsite and in ourpreprint.
The engine is working. We have results across six disease areas and have mappednearly as many targets as the field reported in 20 years. Anovel osteoarthritis candidate is in IND-enabling studies, and we've started an obesitydrug-discovery collaboration with Pfizer. Now we're taking our first AAV program toward the clinic, and what we do here will set the precedent for gene therapies in prevalent disease.
The Project
We're looking for an AAV CMC expert to help take our first gene therapy program to first-in-human, on an aggressive timeline. You'll size up where our CMC stands, shape our strategy with our external CDMO, and run the regular working meetings that keep the CDMO moving fast and delivering the right quality and quantity of material, on time. You bring the expertise and the recommendations; Gordian makes the final program calls.
This is a hands-on engagement, not a name on a slide. You'll set the agenda for CDMO meetings, bring sharp recommendations on process, analytics, and release, turn every meeting into clear next steps, and follow up until the CDMO delivers, pushing timelines when they need pushing. How you get there is up to you.
What You'll Deliver:
In the first month, you'll run a thorough CMC gap analysis against our target product profile and hand us a prioritized plan for closing any gaps you find. You'll also bring your technical eye to our CDMO master services agreement and the initial process development and manufacturing plan.
Through months 1–6, you'll run the CDMO working meetings, turn each one into written next steps with owners and due dates, and chase deliverables to the finish line. You'll guide upstream, downstream, and analytical development, including a phase-appropriate potency assay strategy, and draft Module 3 for our pre-IND package so we get the most out of our FDA interaction.
By six months, the CDMO's non-GMP engineering run will have delivered material for our GLP-tox study, and you'll have drafted Module 3 content for our pre-IND and IND submissions. You'll prepare the CMC briefing and walk into FDA meetings as our CMC expert, ready to take the agency's questions.
And You
You're an independent CMC consultant who has done this before and wants to do it again on something first-of-its-kind. You bring the judgment of a seasoned CMC pro, make well-supported recommendations, and are comfortable holding a CDMO accountable to timelines and quality. When a manufacturing question needs an answer, you go back to the science to settle it.
You must have:
- Taken an AAV gene therapy through CMC to a first-in-human Phase 1 trial
- Experience with a triple-transfection HEK293 suspension process
- Managed external vendors with strength in project management, conflict resolution, and holding timelines.
- Written or substantially contributed to Module 3 of a pre-IND and IND application
Bonus points if you have:
- Directly managed CDMOs for AAV manufacturing
- Taken multiple products through successful INDs and GMP batches
- Experience with analytical development in a GLP/GMP setting
- Broad fluency across CMC: process development, analytical development, drug substance, drug product, and supply chain
- Taking an AAV into later-phase trials or commercialization
- Designing large-animal IND-enabling or toxicology studies
- Sharp regulatory judgment
The Details:
- Independent consulting. You'll work as an independent contractor under a consulting agreement, with the specifics set out in a Statement of Work once we've found the right fit. You're free to keep working with your other clients barring any conflict of interest.
- Timing. A project of roughly six months, kicking off in December 2026.
- Flexible hours. Roughly 20–40 hours a week depending on the phase, on your own schedule around CDMO meetings and milestones.
- Remote, with occasional trips to Gordian HQ to present major deliverables and to the CDMO as manufacturing ramps up. Travel expenses are covered.
Application Due Date: 10/30 and will be evaluated on a rolling basis
If you want to guide a first-of-its-kind gene therapy to the clinic, we'd love to hear from you.
Originally posted on Himalayas