Key responsibilities:
- Accountable for batch production, including safety, Quality and deliverables.
- Responsible for production campaign planning and execution within the timeline.
- Responsible for maintaining the GMP facilities within the validated state and ensure equipment’s maintenance, Calibration and requalification’s are being carried out within the approved frequency.
- Provide support for validation protocol review and approval.
- Provide technical support for new product introduction, facility fit assessment, FMEA and change control implementation.
- Be a technical process expert by exhibiting basic understanding of critical process/operational parameters and acceptable ranges, as well as interactions between different process parameters.
- Ensure Standard Operating Procedures (SOPs), logbooks & Batch Manufacturing Records (BMR’s) are followed effectively & competently
- Provide support for internal and external audit as a spoke person for the GMP facility and Production process.
- Support for Change control, Deviations, investigations and CAPA initiation and closure
- Ensure appropriate staffing levels and skill sets are maintained.
- Ensure team dynamics is built and maintained.
- Recognize and appreciate employee contributions and support workforce diversity.
- Ensure that employees are working in a safe and compliant manner.
- Encourage a culture of continuous improvement.
- Commitment to a fair and respectful relationship to others and behaviour in accordance with company’s Code of Conduct.
- Any other duties as assigned by the supervisor.
Cell Culture (Upstream)
- Skills and knowledge of aseptic technique for thaw and subculture stages using T flasks and Cell factories, etc.
- Knowledge of handling Cell culture, trypsinization, Centrifugation and resuspension. Cell Culture Passaging from flask / Cell factories.
- Benchtop set up for Cell culture supernatant Clarification
Purification (Downstream)
- 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.
Key requirements:
- Degree in a related Science/Engineering discipline
- 5 to 6 years of managerial experience for 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.
