Director, Process Development

4 weeks ago


Singapore VALERE SG PTE. LTD. Full time
Roles & Responsibilities

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.



Tell employers what skills you have

Vocal
Quality Management Systems
Physics
Manufacturing Processes
GMP
Formulation
Protocol
Authorization
Team Leadership
Manufacturing Process Management
Team Management
Project Engineering
People Management Experience
Manufacturing
Chemical Engineering

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