Senior Scientist
Healthcare Recruiters International
The role You’ll own end-to-end development and manufacturing of real-time PCR reagents—from primer/probe design through scale-up, QC, and lot release. If you’re equal parts designer, optimizer, and disciplined documenter, you’ll thrive here. What you’ll do Design highly specific primers/probes (hydrolysis/other chemistries) with rigorous in-silico analysis (BLAST, cross-reactivity, dimer/secondary structure, multiplex compatibility). Develop & optimize qPCR assays (singleplex - multiplex): annealing temps, Mg/dNTP balance, enzyme selection, inhibitors tolerance, efficiency (90-110%), linearity, and reproducibility. Formulate master mixes and buffers; evaluate stabilizers and excipients; contribute to lyophilized/liquid formats and fill/finish. Validate assays to CLSI-style expectations (e.g., LoD, precision, inclusivity/exclusivity, interference, carryover); plan and execute real-time/accelerated stability studies. Transfer to manufacturing: create DMR/lot records, SOPs, WI/batch records; train production; support CAPA/NCs. QC & lot release: define acceptance criteria (Cq, efficiency, R2, NTC behavior), build control strategies, and troubleshoot failures fast. Platform breadth: qualify methods across common thermocyclers and extraction workflows; ensure cross-platform thermal protocols when feasible. Data & documentation: keep airtight ELN, author clear reports, and communicate results crisply to Ops/QA/Reg. Minimum qualifications MS/PhD in Molecular Biology, Biochemistry, Bioengineering, or related field. 3+ years hands-on qPCR assay design and wet-lab optimization (industry preferred). Fluency with Primer3/PrimerQuest, OligoAnalyzer, NCBI BLAST, and multiplex design principles. Proven track record taking assays from concept - validated method - manufactured product. Strong grasp of GxP/ISO-style documentation and change control. Comfort analyzing data in Excel/R/Python or platform software (e.g., QuantStudio/CFX Manager) #J-18808-Ljbffr Healthcare Recruiters International
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