Cell and Gene Therapy Manufacturing Manager

5 days ago


Singapore CELLVEC PTE. LTD. Full time
Job Description

We are seeking an experienced Cell and Gene Therapy Manufacturing Manager to join our team at CELLVEC PTE. LTD.

About the Role

This is a senior leadership position responsible for managing batch production, ensuring safety, quality, and deliverables. The successful candidate will be accountable for production campaign planning and execution within the timeline.

Key Responsibilities
  • Manage and maintain GMP facilities in a validated state, ensuring equipment maintenance, calibration, and requalification are carried out as per approved frequency.
  • Provide technical support for validation protocol review and approval, new product introduction, facility fit assessment, FMEA, and change control implementation.
  • Be a technical process expert, exhibiting a basic understanding of critical process/operational parameters and acceptable ranges, as well as interactions between different process parameters.
  • Ensure Standard Operating Procedures (SOPs), logbooks, and Batch Manufacturing Records (BMR's) are followed effectively and competently.
  • Support internal and external audits as a spokesperson for the GMP facility and Production process.
  • Manage Change control, Deviations, investigations, and CAPA initiation and closure.
  • Maintain appropriate staffing levels and skill sets, build and maintain team dynamics, recognize and appreciate employee contributions, and support workforce diversity.
  • Ensure employees work in a safe and compliant manner, encourage a culture of continuous improvement, and commit to a fair and respectful relationship with others.
Technical Requirements
  • Skills and knowledge of aseptic technique for thaw and subculture stages using T flasks and Cell factories.
  • Knowledge of handling Cell culture, trypsinization, Centrifugation, and resuspension, as well as Cell Culture Passaging from flask/Celld factories.
  • Benchtop setup for Cell culture supernatant Clarification.
  • Skills and knowledge of small-scale column chromatography techniques, tangential flow filtration techniques, Final Filling techniques in BSC and Isolators.
  • Knowledge in handling single-use chromatography columns and tangential flow filtration skids.
Requirements
  • Degree in a related Science/Engineering discipline.
  • 5 to 6 years of managerial experience in managing cell and gene therapy or similar manufacturing industry.
  • Knowledge of Viral Vector manufacturing and Gene Therapy application is an added advantage.
  • Knowledge of Aseptic Manufacturing process for Drug substance and Drug product is an added advantage.
  • Knowledge of cGMP applications.
  • Positive team-oriented attitude.
  • Strong communication and interpersonal skills.
Estimated Salary

$120,000 - $150,000 per annum, depending on experience and qualifications.



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