Staff Manufacturing Engineer
🚀 Staff Manufacturing Engineer - Advanced Cancer Diagnostics (IVD)
Confidential | Fast‑Growing HealthTech | Newly Funded
A rapidly scaling diagnostics innovator-focused on transforming early cancer detection-is seeking a Staff Manufacturing Specialist to lead Functional QC (FQC), validation, and optimization for next‑generation, cfDNA‑based assays.
Backed by a recent $70M Series C, this team is expanding quickly and investing heavily in manufacturing, automation, and quality infrastructure. This is an opportunity to join at a pivotal moment and help shape a platform with global impact.
What You'll Do
- Lead the Functional QC strategy for a complex NGS-based assay program.
- Partner with R&D on tech transfer of new assays, reagents, and controls into manufacturing QC.
- Develop, validate, and improve functional QC workflows across the reagent lifecycle.
- Act as SME for performance testing across cfDNA extraction, library prep, capture, amplification, and sequencing.
- Support batch release, investigations, and CAPA activities.
- Drive robustness, automation, and process standardization to scale manufacturing efficiently.
- Ensure compliance with GMP, ISO 13485, CLIA, and FDA requirements.
- Contribute to documentation, SOPs, and regulatory submissions.
- Mentor manufacturing staff and represent QC in cross‑functional initiatives.
What You Bring
- PhD (or Master's with significant experience) in Molecular Biology, Biochemistry, Biotechnology, Genetics, or similar.
- 8-12+ years in IVD manufacturing, diagnostics, or biopharma with a strong QC focus.
- Hands‑on expertise with NGS workflows and molecular assays (qPCR, enzymatic assays, functional controls).
- Experience developing & validating performance‑based QC assays.
- Familiarity with automation platforms and QC data analysis.
- Strong data interpretation and technical writing skills.
Why This Role Stands Out
✨ Newly secured $70M in Series C funding-meaning real resources, team expansion, and accelerated growth.
✨ Work on a mission‑driven platform targeting the earliest, most treatable stages of cancer.
✨ High technical ownership + opportunity to influence manufacturing strategy and future scaling.
If you believe you'd make a good fit for this role, please apply in now.
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