Director Level (level TBD based on experience), Analytical Development

Role Summary

Role: Director level, Analytical Development (level TBD based on experience). Lead the analytical development team responsible for Century's quality control and characterization platform for iPSC-derived cell therapies. The role provides strategic and scientific guidance, oversees the selection of analytical technologies, establishment of analytical procedures, and the qualification/validation and transfer of methods in support of early development. The role collaborates with internal and external partners to advance pipeline programs through key CMC milestones. This position is based in Branchburg, NJ at the GMP manufacturing facility.

Responsibilities

• Provide strategic, technical, and scientific leadership to the Analytical Development team.
• Function as an analytical lead in early development product teams to deliver on corporate objectives related to the advancement of the company’s pipeline programs.
• Define the product control strategy for Century's pipeline of genetically-engineered, iPSC-derived cell therapy products.
• Foster the growth of analytical development capabilities, including the implementation of state-of-the-art, phase-appropriate methods in support of product and process characterization, comparability, and quality control activities.
• Oversee execution of analytical method development, optimization, transfer, and qualification/validation under cGMP in collaboration with Quality Control in order to prepare assays for clinical trial product testing and release.
• Apply expertise in cell and molecular biology to analytical development over the course of the analytical procedure lifecycle and in support of technical investigations.
• Author, review, and approve technical documents such as study protocols, methods, validation protocols and reports, and regulatory documentation, in collaboration with QC.
• Responsible for resourcing, scheduling, and coordinating laboratory activities to meet organization objectives.
• Ensure systems, processes, and resources are in place to conduct laboratory activities in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards.

Qualifications

• Required: Ph.D. in Biochemistry, Cell Biology, Molecular Biology, Biotechnology, Biological Sciences, Biomedical Engineering or related discipline.
• Required: At least 12 years relevant experience in biopharmaceutical assay development, with minimum 3 years in a managerial capacity.
• Required: Extensive experience in leading analytical activities to support IND, Phase I/II, pivotal, and commercial activities in the biotech or pharmaceutical industry.
• Required: Extensive experience in analytical method lifecycle management, including method development and validation per ICH Q2(R1) guidelines.
• Required: Demonstrated leadership skills, including the ability to manage a scientific team; work effectively within a matrix team; communicate, coach, and mentor employees.
• Required: Strong scientific reasoning, problem-solving, and technical skills in molecular and cell-based methods, including but not limited to PCR-based techniques, flow cytometry, and cell-based assays.