Jobs at SystImmune

Support biostatistical activities for Phase 1–3 clinical trials, including statistical analysis plans, study design, sample size estimation, statistical programming, data integrity review, and interpretation of results. Collaborate with clinical, regulatory, data management, programming, and international teams, including colleagues in China, to communicate findings and support clinical development decisions.

Conduct antibody discovery research by amplifying BCR sequences from sorted B-cells, analyzing sequences, and designing, cloning, and expressing recombinant monoclonal antibodies. The role also involves antibody humanization, molecular biology techniques, laboratory documentation, reporting, safety compliance, and maintaining lab organization. This is a full-time onsite position supporting preclinical therapeutic antibody development.

Designs, develops, executes, and automates high-throughput bioanalytical and functional assays for immuno-oncology antibody therapeutics. Performs hands-on BSL-2 laboratory work, troubleshoots assays, manages samples and quality control through LIMS, documents results, supports IND-enabling studies and regulatory audits, and mentors junior scientists. Collaborates with discovery and translational teams while contributing to assay standardization, automation, and regulatory submissions.

Perform molecular biology and protein engineering workflows, including cloning, plasmid construction, bacterial transformation, and plasmid purification, to support therapeutic antibody development. Maintain detailed electronic lab records, collaborate on construct generation, troubleshoot and optimize workflows, manage multiple projects, and maintain laboratory organization and inventory. The role is full-time onsite and follows a Thursday-through-Monday schedule.

Administer and configure pharmacovigilance safety databases, ensuring data integrity, security, regulatory compliance, and system validation. Support integrations with E2B gateways, submission platforms, and signal detection tools. Provide user support and training, manage access roles, troubleshoot issues, and generate validated safety reports, metrics, and dashboards. Contribute to database upgrades, migrations, automation, audit readiness, and documentation while collaborating with PV operations and cross-functional teams.

Perform molecular biology and protein engineering workflows to generate and characterize therapeutic antibody constructs. Responsibilities include cloning, plasmid design, library preparation, protein binding assays using BLI and SPR, high-throughput analytical workflows, automation support, documentation, troubleshooting, inventory management, and collaboration on protein expression construct generation.

Perform protein purification using FPLC ÄKTA, HPLC, and UPLC systems; develop scalable purification workflows for antibodies and recombinant proteins; characterize protein purity, aggregation, and developability; support CHO cell culture, transient mammalian expression, harvest processing, and biochemical analyses. Maintain detailed electronic records, troubleshoot workflows, collaborate with scientists, and improve purification and analytical processes supporting therapeutic antibody discovery and preclinical development.

Supports statistical programming for clinical trials by developing and validating SDTM and ADaM datasets, Define.xml documentation, tables, figures, and listings. Collaborates with biostatisticians and cross-functional teams, reviews study specifications, develops SAS programs and macros, ensures data quality and regulatory compliance, and contributes to process improvements. The role offers early-career exposure to end-to-end clinical development, with oncology experience preferred.

Lead statistical programming across complex clinical development programs, overseeing datasets, tables, listings, graphs, regulatory submissions, programming teams, and external vendors. Develop and review programming plans, validation procedures, and regulatory deliverables; support biostatistics and cross-functional study teams; maintain SOPs and archives; estimate project resources; and ensure high-quality, timely outputs for FDA, EMA, NMPA, PMDA, and other agencies.

The role involves designing and developing novel assays, proteins, and data analysis for biologics drug development, with responsibilities in functional screening and optimization of biologics leads.

The Director of Protein Engineering will lead the FUSE team, managing scientists and advancing yeast display platforms, ensuring effective drug discovery for cancer treatments.

Lead the development of immunohistochemistry CDx assays, oversee analytical validation, and ensure regulatory compliance within oncology drug programs.

Supports downstream protein purification, characterization, and process development for biopharmaceutical molecules. Performs chromatography, tangential flow filtration, viral clearance, filtration, analytical assays, and low-endotoxin production runs. Uses ÄKTA systems and biophysical instruments, analyzes and reports data, authors SOPs, supports tech transfer to GMP manufacturing, and contributes to process scale-up, scale-down, and timeline planning. The role is full-time onsite and may occasionally require work outside normal hours.

Leads the Protein Sciences function and team supporting oncology biologics discovery through IND-enabling activities. Oversees mammalian protein expression, purification, engineering, and biochemical and biophysical characterization of complex biologics. Establishes scalable, automated workflows, ensures reagent quality and reproducibility, advances candidate molecules, and partners with Protein Engineering, Antibody Discovery, Analytical Sciences, and external organizations. Provides scientific strategy, risk assessment, people leadership, and cross-functional support for antibody, bispecific, multispecific, and ADC programs.

Lead cross-functional planning and execution for oncology biologics programs from discovery through IND-enabling and submission. Build and drive integrated project plans, manage risks and dependencies, facilitate governance and meetings, coordinate external partners/CROs, support budget/resource tracking, and produce executive-ready communications and program metrics.

Support clinical and non-clinical studies by cleaning, visualizing, analyzing, and reporting data. Develop and validate statistical programs (SAS, R, Python), generate TLFs, conduct interim and PK analyses, write/review SAPs, SARs, and CSRs, oversee CRO programming, ensure CDISC-compliant SDTM/ADaM outputs, perform simulations and QC, and apply regulatory statistical standards.

Hands-on lab role to engineer stable mammalian cell lines (lentiviral transduction, CRISPR knock-ins/outs), run and optimize cell-based immunoassays (flow cytometry, ELISA, Incucyte), perform reagent and cell line qualification, analyze datasets, and present technical reports to support immuno-oncology drug discovery and development.

The Executive Director, Finance leads financial strategy supporting clinical programs, managing budgets, vendor relationships, and team leadership within the biotech sector.

This Human Resources Intern role involves coordinating interviews, supporting full-cycle recruiting and HR operations, and assisting with process improvement projects.

Lead Analytical teams and strategy, oversee method development and validation for biologics, ensuring compliance and successful technology transfer between sites.