About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases, including type 1 diabetes, and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care.

Role:

This role can be at either an Associate Director, Director, or Senior Director level based on candidate experience and qualifications. The Director level Analytical Development role is accountable for providing strategic and scientific guidance to the analytical team responsible for developing Century's quality control and characterization platform. With a focus on scientific and technical excellence, this group leader will oversee the selection of analytical technologies, establishment of analytical procedures, and the qualification/validation and transfer of methods in support of early development programs. This role will interact extensively with internal and external partners to advance pipeline programs through key CMC milestones. This role is based in Branchburg, NJ, which is the location of our GMP manufacturing facility and where process and analytical development reside.

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

• Ph.D. in Biochemistry, Cell Biology, Molecular Biology, Biotechnology, Biological Sciences, Biomedical Engineering or related discipline.
• At least 12 years relevant experience in biopharmaceutical assay development, with minimum 3 years in a managerial capacity.

Requirements:

• Extensive experience in leading analytical activities to support IND, Phase I/II, pivotal, and commercial activities in the biotech or pharmaceutical industry.
• Extensive experience in analytical method lifecycle management, including method development and validation per ICH Q2(R1) guidelines.
• Demonstrated leadership skills, including the ability to manage a scientific team; work effectively within a matrix team; communicate, coach, and mentor employees.
• 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.

Century Therapeutics Inc. is an Equal Employment Opportunity/Affirmative Action Employer - Minority/Female/Disability/Veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status or any other characteristic protected by federal, state, or local law.