Director, Process Development

1 day ago

Singapore GDMC Full time

Genetic Design and Manufacturing (GDMC) is a next generation design and manufacturing organization focused on reducing time to clinic and patient for next-gen advanced medicines. We achieve that goal by partnering with and supporting early stage companies and investigators by bringing our expertise to bear on designing a novel modality and process to be transferable to manufacturing, and then progressing through manufacturing to scale-up for clinical trials in close partnership.

**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 the 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
- Work authorization in Singapore
- 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

**Desired** **Qualifications**
- 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 visualisations. Strong demonstrable management, organisational and planning skills

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