GMP Manufacturing Operations Manager
1 week ago
About Yapan Bio
Piramal Pharma Solutions is a leading provider of GMP manufacturing services, with state-of-the-art facilities and a commitment to quality and regulatory compliance.
Job Overview
The incumbent will be responsible for managing the overall manufacturing operations for the organization, involving multiple facilities. This position requires demonstrated ability to work effectively as both technical and people leader, manage tasks, resolve problems and issues and drive implementation/action plans to meet objectives.
Responsibilities
- Responsible for complete GMP operations from media and buffer preparation, upstream and downstream process to finished product for manufacturing of clinical material for vaccine and biologic/bio therapeutic products.
- Review Authority of SOPs, BMR, BPR etc.
- Planning, execution, and documentation of all the activities related to the GMP operations as per the global quality and regulatory compliance.
- Implementation of quality systems with support of the Quality team of the organization.
- Execution of production batches/operations under GMP, complying to the Quality systems of the organization.
- Ensure optimal utilization of resources (facility, equipment, and manpower).
- Ensure Audit readiness / compliance for the facility, equipment, and operations at all times.
- Coordinate with cross functional teams like QA, QC, HR, Supply Chain, Maintenance & Engineering to manage the daily operations smoothly.
- Prepare and execute the production plan as per the project requirements.
- Introduce new systems and procedures where appropriate.
- Manage, engage, and interact with the relevant stakeholders for preparation and presentation of data, reports, and documents in the relevant formats regularly.
Requirements
- Postgraduate or PhD degree in a relevant Science or Engineering field.
- 20 or more years of experience in the GMP manufacturing/operations in mABs gene therapy recombinant vaccines and/or biologics industry.
- Demonstrated ability to manage entire GMP manufacturing operations with key focus on time bound delivery and quality.
- Experience in single use/disposable bio process equipment and technologies.
- Experience with regulatory inspections and inspection readiness.
- Strong team player with demonstrated track record of success in a cross-functional team and fast-moving environment.
Estimated Salary Range: $150,000 - $200,000 per annum
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