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)