Senior Production Manager Cell Culture and Purification Lead
4 weeks ago
We are seeking a Senior Production Manager to lead our Cell Culture and Purification teams at CELLVEC PTE. LTD.
About the Role
The successful candidate will be responsible for overseeing the production of cell-based therapeutics, ensuring timely delivery, and maintaining high-quality standards.
Key Responsibilities:
- Plan and execute production campaigns within tight timelines.
- Maintain GMP facilities in a validated state and ensure equipment maintenance, calibration, and requalification.
- Support validation protocol review and approval.
- Provide technical expertise for new product introduction, facility fit assessments, FMEA, and change control implementation.
- Develop and maintain Standard Operating Procedures (SOPs), logbooks, and Batch Manufacturing Records (BMRs).
- Lead internal and external audits as the spokesperson for the GMP facility and production process.
- Initiate and close Change Control, Deviations, investigations, and CAPAs.
- Maintain appropriate staffing levels and skill sets.
- Foster team dynamics and employee recognition.
- Ensure safe and compliant working environments.
- Cultivate a culture of continuous improvement.
Requirements:
- Degree in a related Science/Engineering discipline.
- 5-6 years of managerial experience in cell and gene therapy or similar manufacturing industry.
- Knowledge of Viral Vector manufacturing and Gene Therapy application is an added advantage.
- Aseptic Manufacturing process knowledge for Drug substance and Drug product is an added advantage.
- cGMP applications knowledge.
- Positive team-oriented attitude.
- Strong communication and interpersonal skills.
Estimated Salary: SGD 120,000 - 180,000 per annum
Benefits:
- Competitive salary and bonus structure.
- Comprehensive benefits package including medical, dental, and life insurance.
- Retirement plan and professional development opportunities.
Others:
- A unique opportunity to work with a leading biotechnology company.
- Contribute to the development of innovative cell-based therapeutics.
- Collaborate with a talented team of professionals.
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