Scientist, Reagent Process Development

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest time points, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development.

Personalis is based in Fremont, California.

We are seeking a results-driven, hands-on Process Development Scientist to join our exciting team. In this role, you will be responsible for translating R&D breakthroughs into reagent production processes, specifically focusing on formulations, packaging, and QC assays/specifications. This position bridges R&D and Manufacturing, ensuring that new products are robust, scalable, cost-effective, and compliant with ISO 13485/GMP standards.

• Formulation Process Development:
  Develop and optimize manufacturing methods for reagent formulations to ensure consistency, functionality, and stability.
• Reagent Packaging Process Development:
  Design and implement accurate and reproducible filling, dispensing, labeling, and sealing processes for liquid reagents into tubes and multi-well plates.
• Scale-Up:
  Transition laboratory-scale formulations and manual filling processes into robust, automated, or semi-automated production-scale processes. Evaluate outsourcing to contract manufacturers, as needed. Design scaled up and practical manufacturing processes, while identifying Critical Process Parameters and Critical Quality Attributes.
• QC Assay Development & Specs:
  Develop relevant in-process and finished product test methods (e.g. pH/conductivity, absorbance, real time PCR, library prep, sequencing, etc.) to ensure release of high-quality products.
• Validation:
  Generate validation plans/reports and execute studies to release robust new production processes, QC assays, and new equipment into Reagent Manufacturing.
• Technology Transfer:
  Collaborate with R&D for new product introduction (NPI) and transfer processes to Manufacturing, including drafting Standard Operating Procedures (SOPs) and Batch Records (BRs).
• Troubleshooting:
  Investigate and resolve manufacturing issues, including production failures and out-of-specification (OOS). Identify root cause and quickly implement effective solutions.
• Quality & Compliance:
  Ensure all developed processes and documentation comply with ISO 13485, GMP, and internal quality standards.

• Education:
  
  PhD in Molecular Biology, Biochemistry, Chemistry, or Chemical Engineering with 1-3+ years of industry experience; or Master's degree with 3-5+ years; or Bachelor’s degree with 5+ years.
• Technical
  
  Skills:
  • Hands‑on experience with molecular biology techniques (qPCR, PCR, enzyme assays, Library Preparation, Next Gen Sequencing).
  • Experience with oligonucleotides, enzymes, reagent formulation, mixing, and filling.
  • Expertise in scale up and technology transfer.
  • Knowledgeable in high throughput liquid handling automation (e.g., Tecan, Hamilton) and reagent packaging technology for tube/plate dispensing and labeling, a plus.
  • Experience:
    
    Proven track record of independent achievements in reagent process development, NPI/technical transfer, or manufacturing support within a regulated IVD, clinical, or biotechnology environment.
  • Software:
    Proficiency in data analysis software (e.g., JMP, Minitab, Excel) and LIMs Systems. Familiarity with PLM, ERP, and MES systems, a plus.
  • Documentation:
    Strong technical writing skills for SOPs/batch records, validation protocols, and technical reports.
  • Quality Systems:
    Strong understanding of ISO
    13485, GLP/GMP, and operating under strict SOPs.

• Detailed-oriented and analytical with excellent problem-solving skills and a process improvement mindset.
• Strong collaboration skills, working across R&D, Manufacturing, and QA/QC.
• Capable of managing multiple projects in fast-paced,…