Open role
Chief Technology Officer (CTO)
招聘职位
首席技术官(CTO)
The role
You will be our first technology leader. You own the path that turns a research-grade assay into a manufacturable, validated IVD product ready for registration and launch — and you make the decisions that define the product for the next decade.
What you will own
- Technology transfer — take the research protocol to its productized form: platform choice (qPCR / ddPCR / targeted methylation sequencing), reagent design, cutoff definition, reference materials.
- CDMO / CRO strategy — select, contract and manage development and manufacturing partners; own the technical statement of work, milestone acceptance and quality gates.
- Analytical validation — design and run analytical performance studies (LoD, precision, reproducibility, interference, specimen stability) to support regulatory filings.
- Platform and IP — build the freedom-to-operate map and the defensive patent position around assay chemistry and workflow, with leadership and counsel.
- Bridge — translate between our scientific founders, the regulatory and clinical team, and external partners.
- Team — build and lead a technology-transfer team as milestones unlock.
What you bring
- 10+ years in molecular diagnostics product development, with hands-on ownership of at least one IVD product from prototype to regulatory submission.
- Deep expertise in DNA methylation chemistry (bisulfite or enzymatic conversion, MSP/MethyLight) and/or qPCR, ddPCR or targeted NGS assay design.
- A track record managing CDMO/CRO partners — from the sponsor side or from senior roles inside an IVD CDMO.
- Working knowledge of IVD registration pathways and ISO 13485 design controls.
- Fluent professional English and Mandarin.
- You are comfortable building from zero: high autonomy, few resources, direct impact.
Nice to have
- PhD in molecular biology, biochemistry, bioengineering or a related field.
- Companion diagnostic (drug–diagnostic co-development) experience.
- Experience with LDT launches in China's pilot programs.
- Founding-team experience at a diagnostics start-up.
How to apply
Email your CV and a one-page note to contact@linnaeabio.com with the subject "CTO — [Your Name]".
职位概述
作为公司首位技术负责人,你将主导把一项研究阶段的检测方法,发展为可稳定生产、经过充分验证、具备注册与上市条件的 IVD 产品。你的关键决策,将决定这款产品未来十年的走向。
主要职责
- 技术转移——将研究方案转化为成熟产品,包括检测平台选择(qPCR / ddPCR / 靶向甲基化测序)、试剂设计、判读阈值(cutoff)设定及参考品建立。
- CDMO / CRO 管理——遴选并管理研发与生产合作方,负责技术方案、里程碑验收和质量把控。
- 分析性能验证——设计并完成检出限、精密度、重复性、干扰、样本稳定性等分析性能研究,为注册申报提供支持。
- 平台与知识产权——与管理层及法律顾问合作,围绕检测化学与工作流程开展自由实施(FTO)分析,建立防御性专利布局。
- 跨团队协同——衔接科学创始人、法规与临床团队以及外部合作方,确保技术沟通顺畅高效。
- 团队建设——随项目推进,组建并带领技术转移团队。
任职要求
- 10 年以上分子诊断产品开发经验,亲自主导过至少一款 IVD 产品从原型到注册申报的全过程。
- 精通 DNA 甲基化检测技术(亚硫酸氢盐或酶法转化、MSP/MethyLight),和/或 qPCR、ddPCR、靶向 NGS 检测设计。
- 具备管理 CDMO/CRO 合作方的实际经验,申办方或 IVD CDMO 高级岗位背景均可。
- 熟悉体外诊断产品注册路径及 ISO 13485 设计控制要求。
- 中英文均可作为工作语言。
- 适应从零起步的创业环境,能够独立推动工作,在有限资源下取得实质成果。
优先条件
- 分子生物学、生物化学、生物工程或相关专业博士学位。
- 伴随诊断(药物与诊断联合开发)经验。
- 参与过国内 LDT 试点项目落地。
- 诊断领域初创企业创始团队经历。
如何申请
请将简历及一页自荐信发送至 contact@linnaeabio.com,邮件标题请注明 "CTO — [姓名]"。