Scientist/Senior Scientist - Bioanalytical Development - qPCR

Dash Bio is seeking a molecular scientist to invent, validate, and transfer the qPCR and ddPCR methods that power our automated bioanalysis lab. You will build the nucleic acid assays behind biodistribution, vector copy number, transgene expression, shedding, and biomarker programs, and the analysis frameworks that turn their data into defensible results.

Much of this work has no playbook. New modalities arrive faster than guidance documents, difficult matrices break textbook approaches, and sponsors need a credible answer before a validated method exists. We are looking for scientists who will invent the approach, size the rigor to the decision it supports, and say plainly what the data can and cannot carry. Regulated work is the floor here, not the ceiling: we expect you to know the guidances well enough to argue with them and to propose something better when the standard approach does not fit the problem.

This is a hands-on, on-site role partnering closely with Automation, Quality, and Software to take methods from concept through validation and into routine GLP operation. You will have real latitude over platforms, chemistries, and analysis approaches, and real ownership of the result. Level will be matched to experience (Scientist through Senior Scientist).

Key Responsibilities:

Method Development and Innovation:

●      Design, optimize, and troubleshoot qPCR/RT-qPCR and ddPCR methods, singleplex through multiplex, for biodistribution, vector copy number, transgene and RNA expression, viral shedding, and MRD-style biomarker applications, including first-in-kind assays with no established precedent.

●      Own the assay end to end: primer and probe design, duplex/multiplex channel compatibility, extraction chemistry and recovery, reference gene selection, and standard, calibrator, and control strategy.

●      Work fluently across real-time and partition-based platforms (e.g., QuantStudio, Bio-Rad, Stilla naica), evaluate emerging chemistries and instruments, and make the call on what we adopt.

●      Prototype fast: design the small, decisive experiment that kills a bad idea in a week, then scale what survives into a robust method.

●      Partner with automation engineers to move extraction and plate setup onto liquid handlers and integrated robotics (e.g., Hamilton, KingFisher), and with software and data science teams on instrument exports, LIMS integration, and analysis pipelines.

Technical Excellence and Problem-Solving:

●      Troubleshoot assay performance with data rather than cookbook methodology: amplification efficiency, inhibition, rain and partition separation, channel crosstalk, and contamination control.

●      Qualify critical reagents and materials, including master mixes, primer/probe lots, plasmid and gBlock standards, and extraction kits; design and execute bridging and lot-to-lot comparability studies.

●      Define sample handling workflows across challenging matrices (blood, tissue, PBMC, plasma): extraction recovery and pre-/post-extraction spike designs, stability, freeze-thaw, dilution linearity, and selectivity.

●      Use design of experiments (DOE) and statistical thinking to get more information from fewer runs while establishing LOD/LOQ, precision, accuracy, specificity, linearity and range, robustness, and stability, with criteria appropriate to absolute (dPCR) versus relative (qPCR) quantification.

●      Make risk-adjusted calls about where experimental effort goes: what must be locked down before a GLP run, what can be characterized and reported, and what is not worth chasing, with the reasoning written down.

Documentation and Regulatory Alignment:

●      Author method development reports, validation plans and protocols, and validation reports aligned with ICH M10, FDA bioanalytical guidance, MIQE, and current AAPS/WRIB qPCR and dPCR white papers, capturing the scientific rationale and not only the procedure.

●      Build acceptance criteria and control strategies from primary literature and first principles rather than inherited templates, including for assays where no certified reference material exists; implement qualified and validated methods for GLP operations with the automation team.

●      Communicate complex technical findings, and their uncertainty, to internal teams, clients, and regulatory audiences, translating data into actionable decisions on project and submission strategy.

Leadership and Collaboration:

●      Manage multiple concurrent client programs while holding quality standards, timelines, and GLP compliance.

●      Mentor junior scientists and technicians in experimental design, data interpretation, and sound molecular technique.

●      Serve as the qPCR/ddPCR subject matter expert in client and regulatory discussions, with the standing to propose a better design when the requested one will not answer the question.

●      Build what outlasts the study: reusable analysis templates, tooling, SOPs, and platform standards that raise the floor for every program that follows.

Qualifications:

Required:

●      BS/MS/PhD in Life Sciences (Molecular Biology, Biochemistry, Bioengineering, Analytical Chemistry, or related field) with 3+ years of hands-on qPCR and/or ddPCR experience

●      Demonstrated method development experience: assay design, optimization, troubleshooting, and performance characterization

●      Working knowledge of nucleic acid extraction from complex biological matrices and the recovery and inhibition problems that come with it

●      Strong quantitative data analysis, statistics, and experimental design skills; able to build and defend your own analysis of raw instrument data

●      Evidence that you have built something that did not exist before, whether a method, a tool, an analysis approach, or a better way of working

●      Excellent scientific writing and communication, including stating uncertainty honestly and changing course when the data says to

Preferred:

●      Hands-on ddPCR experience on partition-based platforms (e.g., Stilla naica, Bio-Rad QX, QIAcuity) alongside real-time qPCR (e.g., QuantStudio)

●      Multiplex assay design, including validation of duplex and triplex channel compatibility

●      Gene therapy or cell therapy bioanalysis: biodistribution, vector copy number, transgene expression, or shedding assays

●      Familiarity with GxP environments and regulatory guidance (ICH M10, FDA BMV, MIQE, 21 CFR 58) deep enough to know what they require versus what is merely convention

●      Experience with automated liquid handling and extraction systems (e.g., Hamilton, KingFisher)

●      Programming or scripting for data analysis, QC, and reporting (Python, R, or similar)

What sets successful candidates apart:

●      You reason from first principles and will discard a standard approach when it does not fit the problem

●      You take risk-adjusted bets: you can tell which experiments carry real information and which are ritual, and you spend effort accordingly

●      You have built tools, templates, or workflows because the existing ones were not good enough

●      You are comfortable working ahead of precedent, with the judgment to know which corners are safe to cut and which are not

●      You want colleagues who will challenge your design, and you will challenge theirs