Cell and Gene Therapy Manufacturing Manager
5 days ago
We are seeking an experienced Cell and Gene Therapy Manufacturing Manager to join our team at CELLVEC PTE. LTD.
About the RoleThis 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.
- 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.
- 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.
$120,000 - $150,000 per annum, depending on experience and qualifications.
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