Director, Process Development
1 week ago
"Any sufficiently advanced technology is indistinguishable from magic. -Arthur C. Clark"_ At Genetic Design and Manufacturing Corporation (GDMC), we believe in bringing the magic of novel genetic medicines to patients by innovating in manufacturing technologies that are critical to the delivery of that vision. This exponential improvement in manufacturing will allow for de-bottleneck the clinical testing and approval of new genetic medicines such as gene therapies to make blind people see, or the next mRNA vaccines. GDMC is a venture-backed, fast-paced and Singapore-HQ'ed start-up and we want you to join us on this mission, to accelerate our growth by sourcing, screening and supplying key talent for all of GDMC **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.
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