Responsibilities
- Direct and coordinate all USP/DSP activities as well as oversee the supervision and training of personnel.
- Develop, implement, scale and project appropriate USP/DSPs processes, along with analytical method development and testing using appropriate statistical approaches.
- Oversee development and implementation of formulation and fill/finish operations.
- Determine a robust Process Performance Qualification (PPQ) protocol strategy, to include generation of appropriate acceptance criteria.
- Responsible for all stages process development (FIH, CPD, MSAT) for all programs within the pipeline.
- Liaise with manufacturing team to ensure efficient process and aligned strategic goals.
- Oversee development of drug substance and drug product release specifications.
- Develop tech transfer plans for processes moving from process development to GMP manufacturing.
- Coordinates with regulatory filing requirements (including INDs, BLAs and formal responses to inquiries).
Requirements
- PhD Degree in Bioprocessing, Biochemical Engineering or Chemical Engineering, Bioengineering related discipline.
- 10+ years of relevant industry experience.
- Understanding of bioprocessing and manufacturing processes in the gene therapy and vaccine space.
- Demonstrated in-depth knowledge of quality management systems, regulatory requirements and compliance.
- Innovative and analytical thinker with outstanding interpersonal, communication, and leadership skills.
- Demonstrated ability to clearly communicate technical information and roadmaps through presentations containing clean figures and visualizations.
- Strong demonstrable management, organizational and planning skills.
- Work authorization in Singapore.
