Production Manager

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.