Tessa Therapeutics is seeking a CMC leader at director level to lead the process/analytical development and validation, as well as product characterization and manufacturing process capability analysis, for BLA filing for our cell therapy products for cancer patients. The individual will also work closely with Regulatory Affairs, Manufacturing, and Research teams at Tessa. This position is located in Tessa’s corporate headquarter in Singapore.
· Lead a dynamic and matrix team with members from various functional groups to achieve scientific excellence and innovation, while adopting development stage-appropriate practices, in the CMC areas of process, analytical, and formulation development and manufacturing process capability analysis and supply chain qualification.
· Define CMC strategies, deliverables, resource requirement, and timelines to support product development milestones, from preclinical studies, IND filing, clinical study supply, BLA filing, to commercialization, product life cycle management
· Leverage Quality-by-Design (QbD), Process Analytical Technologies (PAT), and risk-based approaches to develop robust processes and analytical procedures to ensure long-term success in manufacturing cell therapy products for vein-to-vein delivery to patients
· Stay current with regulatory requirements and new technologies/methodologies in CMC areas, designs and executes experiments to provide required information and data for regulatory filing, process capability analysis, and investigations.
· Interacts with regulatory authorities through conferences and regulatory filings/meetings, and anticipates regulatory changes and develops proactive strategy accordingly
· Coaches a highly effective and scientifically strong team for ensure efficient technical transfer of processes and assays to manufacturing and quality control teams, including to new GMP locations
· Responsible for supporting and reviewing the CMC sections in regulatory submissions including both pre-approval and post approval submissions such as IND, NDA/BLA, amendments/supplements, annual reports, product characterization study reports, comparability protocols and reports, etc.
· Participate in the product development teams, providing clear and solid recommendations for CMC strategies and execution plans
· Manage external CMC activities in collaboration or outsourcing cases
· PhD or Master in Life Science (e.g. Immunology, Biochemistry, Biotechnology, Biology) or equivalent
· 5+ years proven successful CMC experience in biopharmaceuticals in either cell processing or analytical field under cGMP environment, preferably in leading diversified technical teams
· Excellent working knowledge/experience in CMC areas for cell therapies or biologicals, especially in applying QbD, PAT, DOE, and risk assessment approaches to ensure CMC excellence and identify and control CQAs and CPPs
· Familiar with approval processes for IND and BLA, comparability protocols, and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements
· Highly developed inter-personal skills and verbal/written communication
· Strong problem solving and critical thinking skills
To apply or for inquiry, please contact firstname.lastname@example.org.