Scientist, Reagent Process Development (Biotech)

TL;DR

Scientist, Reagent Process Development (Biotech): Translating R&D breakthroughs into scalable reagent production processes with an accent on formulations, packaging, QC assays, and specifications. Focus on developing scale-up methods, automation for filling and labeling, validation studies, and technology transfer to manufacturing while ensuring ISO 13485/GMP compliance.

Location: Fremont, CA (Onsite)

Salary: $120,000 - $150,000 per year

Company

hirify.global transforms cancer management through personalized testing, combining tumor-and-normal profiling with algorithms to detect minimal residual disease, enable targeted therapies, and support drug development biomarker strategies.

What you will do

• Develop and optimize manufacturing methods for reagent formulations ensuring consistency, functionality, and stability.
• Design reproducible filling, dispensing, labeling, and sealing processes for liquid reagents into tubes and multi-well plates.
• Scale up laboratory processes to production-scale, including automation or outsourcing, identifying critical process parameters and quality attributes.
• Develop in-process and finished product QC assays like pH, absorbance, real-time PCR, library prep, and sequencing.
• Execute validation studies, generate plans and reports for new processes, assays, and equipment.
• Transfer processes to manufacturing via SOPs and batch records, troubleshoot issues, and ensure quality compliance.

Requirements

• PhD in Molecular Biology, Biochemistry, Chemistry, or Chemical Engineering with 1-3+ years industry experience; or MS with 3-5+ years; or BS with 5+ years.
• Hands-on experience with molecular biology techniques (qPCR, PCR, enzyme assays, library prep, NGS), oligonucleotides, enzymes, reagent formulation, mixing, and filling.
• Expertise in scale-up, technology transfer, and high-throughput liquid handling (Tecan, Hamilton a plus).
• Proven track record in reagent process development, NPI, or manufacturing support in regulated IVD/clinical/biotech environments.
• Proficiency in data analysis (JMP, Minitab, Excel), LIMS, technical writing for SOPs, validations; understanding of ISO 13485, GLP/GMP.
• Detail-oriented, analytical problem-solver with collaboration skills across R&D, Manufacturing, QA/QC in fast-paced teams.

Culture & Benefits

• Competitive compensation with annual performance bonus, equity, medical, dental, vision, 401(k) match, ESPP, tuition reimbursement.
• Sick/vacation time, commuter benefits, EV charging, onsite gym, wellness benefits (US only).
• Equal opportunity employer committed to inclusion and reasonable accommodations for disabilities.