Associate Scientist, Analytical Sciences & Quality Control

Cirsium Biosciences is an early-stage biotechnology company developing a novel plant-based platform for AAV production. We are advancing our technology from Research through Process Development and toward clinical and manufacturing readiness.

Position Summary

Department: Research and Development

Position: Contract

Reports To: Research Lead

Location: San Diego, CA

Expected Salary Range: $100-135k, depending on experience and qualifications

The Associate Scientist, Analytical Sciences & Quality Control (QC) is a scientific contributor who designs, executes, and leads analytical work supporting the development, characterization, and assessment of AAV vectors produced on the Company’s plant-based manufacturing platform.

This position independently designs and performs molecular biology, biochemical, microbiological, and AAV-specific analytical assays in support of process development, product characterization, batch testing, and manufacturing readiness. The Associate Scientist develops and optimizes analytical methods, interprets complex datasets, authors technical reports, and owns assigned analytical platforms or assay portfolios.

The role requires strong scientific judgment, laboratory expertise, attention to detail, and the ability to work independently in a fast-paced biotechnology startup environment. The incumbent represents Analytical Sciences in cross-functional project meetings, collaborates closely with upstream process development, downstream process development, and research teams, mentors junior team members, and provides scientific recommendations that influence program direction.

Key responsibilities

AAV Characterization and Molecular QC Assays

Perform routine and development-stage analytical testing of AAV samples, including vector genome quantification using qPCR and digital PCR (dPCR).

Perform AAV capsid titer determination using ELISA and other established analytical methods.

Support characterization of AAV capsid composition, including VP1, VP2, and VP3 protein analysis using SDS-PAGE, Western blotting, JESS, or other appropriate techniques.

Support characterization of full and empty AAV capsids using established analytical methods, including mass photometry or other available technologies.

Execute DNA and RNA extraction, nucleic acid quantification, PCR, qPCR, RT-qPCR, and related molecular biology workflows.

Support analysis of AAV genome integrity, residual DNA, and process-related impurities.

Execute or support endotoxin testing, mycoplasma detection, bioburden assessment, and other microbiological assays as required.

Prepare and maintain reagents, assay standards, reference materials, positive and negative controls, and sample dilutions according to established procedures.

AAV Manufacturing Support

Collaborate with upstream and downstream process development teams to characterize samples generated during AAV production and purification.
Perform QC testing of samples collected at different manufacturing stages, including plant extracts, clarified lysates, process intermediates, and purified vector preparations.
Support process optimization studies by generating analytical data on vector yield, purity, capsid content, genome titer, and product quality.
Assist in evaluating batch-to-batch consistency and identifying potential sources of process variability.
Communicate analytical findings to cross-functional teams to support data-driven process development and manufacturing decisions.

Scientific Leadership and Analytical Development

Design experiments independently, including study plans, controls, and acceptance criteria, to answer analytical and process questions.
Lead analytical development initiatives from planning through execution and handoff.
Develop and optimize new analytical methods to improve sensitivity, robustness, throughput, and suitability for future manufacturing and regulatory requirements.
Own assigned analytical platforms or assay portfolios, including performance monitoring, method lifecycle, and continuous improvement.
Interpret complex datasets and present scientific conclusions and recommendations to internal stakeholders.
Author technical reports and study summaries documenting methods, results, and conclusions.
Make scientific recommendations that influence program direction, process development decisions, and manufacturing strategy.
Represent Analytical Sciences in cross-functional project meetings.
Mentor and provide technical guidance to junior team members.

Documentation and Data Analysis

Maintain accurate and complete laboratory records, including sample information, reagent preparation, raw data, calculations, instrument records, and electronic laboratory notebook entries.
Prepare and review assay worksheets, data summaries, analytical reports, and technical documentation.
Draft, revise, and execute standard operating procedures (SOPs), test methods, and analytical protocols.
Maintain sample traceability, inventory records, and appropriate sample storage conditions.
Support investigation and documentation of assay failures, unexpected results, deviations, and corrective actions.
Support laboratory equipment maintenance, calibration, and troubleshooting.
Analyze and present experimental results using Excel, GraphPad Prism, or other appropriate software.
Maintain organized, accurate, and inspection-ready records consistent with the development stage of the program.

Required Qualifications

Education & Experience

MS or PhD in molecular biology, biochemistry, biotechnology, microbiology, biological sciences, pharmaceutical sciences, or a related discipline.
A minimum of 5 years of hands-on laboratory experience in biotechnology, pharmaceutical research, analytical development, or quality control, including experience designing and leading experiments.

Technical Skills

Strong experience with molecular biology assays, including PCR, qPCR, dPCR, or related nucleic acid quantification techniques.

Hands-on experience with biochemical and protein characterization assays, such as ELISA, SDS-PAGE, Western blotting, or protein quantification.

Experience preparing reagents, standards, assay controls, and biological samples for analytical testing.

Familiarity with assay troubleshooting, data analysis, and interpretation of experimental results.

Professional Skills

Strong laboratory documentation practices, including accurate recording of raw data, calculations, and experimental observations.
Ability to independently design, execute, and interpret experiments and communicate scientific findings and recommendations.
Strong organizational skills, attention to detail, and ability to manage multiple experiments and priorities.
Ability to work collaboratively with multidisciplinary research and process development teams.
Demonstrated ability to mentor junior scientists and technicians and to represent a function in cross-functional teams.

Preferred Qualifications

Previous experience with AAV vectors, viral vector manufacturing, gene therapy, or biologics characterization.
Experience supporting analytical method development, qualification, or technology transfer.
Experience working with process development or manufacturing teams to support batch testing and product characterization.
Knowledge of GxP principles, GMP documentation practices, data integrity, and relevant regulatory expectations for biologics.
Experience working with plant-based expression systems or other alternative biologics manufacturing platforms.
Experience with AAV potency or infectivity assays, including cell-based functional assays.
Experience drafting SOPs, analytical protocols, method qualification reports, or technical summaries.

Physical and Work Environment Requirements

Regular onsite work in a laboratory environment involving biological materials, chemicals, analytical instruments, and research samples.
Ability to wear required personal protective equipment and follow applicable laboratory safety and biosafety procedures.
Ability to perform repetitive pipetting, sample preparation, and other fine-motor laboratory activities.
Ability to stand, sit, bend, reach, and perform laboratory tasks for extended periods.
Ability to occasionally lift or move laboratory supplies and equipment within company safety guidelines.
Occasional schedule flexibility may be required to support time-sensitive analytical testing, sample processing, or manufacturing activities.

What Success Looks Like

QC assays are performed accurately, consistently, and according to established methods and procedures.
Analytical results are reliable, reproducible, and delivered within agreed timelines.
Sample records, raw data, calculations, and laboratory documentation are complete, accurate, and traceable.
Analytical testing supports timely process development decisions, batch characterization, and manufacturing improvements.
QC methods become increasingly robust, standardized, and suitable for future manufacturing and regulatory requirements.
Scientific recommendations are well supported, clearly communicated, and influence program direction.

Additional Information

Disclaimer

This job description is intended to describe the general nature and level of work performed by employees assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, or qualifications. Duties and responsibilities may change at any time based on business needs. Employees may be required to perform other job-related duties as assigned.

Equal Employment Opportunity

Cirsium Biosciences is an Equal Opportunity Employer committed to creating an inclusive workplace. Employment decisions are based on qualifications, merit, business needs, and job requirements. We prohibit discrimination and harassment based on race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, veteran status, marital status, reproductive health decision-making, or any other characteristic protected by federal, state, or local law.

Reasonable Accommodation

Cirsium Biosciences is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the application and employment process. If you require an accommodation to participate in the application process or perform the essential functions of the position, please contact Human Resources.