Jobs at SystImmune

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.

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.

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

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

The HR Business Partner will support various teams by providing HR guidance on performance management, employee relations, recruiting, and organizational effectiveness, while ensuring compliance with laws and policies.

Lead establishment and continuous improvement of a GMP-compliant Quality Management System for IHC-based companion diagnostics (CDx). Oversee transition from RUO/LDT to regulated IVD CDx, design control, ISO 14971 risk management, document control, supplier quality, CAPA and change control. Serve as management representative and primary interface for FDA inspections, audits, and regulatory interactions. Build and mentor a QMS team and drive inspection readiness and regulatory submissions.

Support statistical programming for clinical trials by creating and validating SDTM/ADaM datasets, developing and validating TFLs, and producing Define.xml and reviewer guides. Collaborate with biostatisticians and cross-functional teams, review study documents, develop SAS programs and macros, and ensure outputs meet CDISC standards, regulatory requirements, and SOPs.

Lead CDx IHC development, managing technical strategy, team development, and regulatory compliance for oncology drug programs in a hands-on role.