Head-Oncology OSD Formulation site
Key Responsibilities:
Site Leadership:
- Provide strategic leadership to the manufacturing site, aligning operations with company goals and regulatory requirements.
- Oversee daily operations, ensuring efficient production schedules, quality output, and adherence to safety protocols.
- Lead and mentor a diverse team of professionals, fostering a culture of collaboration, accountability, and continuous improvement.
Regulatory Compliance:
- Ensure all site operations comply with global regulatory standards (e.g., USFDA, EMA, MHRA).
- Maintain a state of audit readiness at all times, successfully leading inspections by regulatory bodies.
- Develop and implement site-specific SOPs in alignment with corporate policies and regulatory requirements.
Oncology OSD Formulation:
- Manage the formulation and production of Oncology Oral Solid Dosage (OSD) forms, ensuring the highest standards of product quality and safety.
- Provide technical expertise in the development and optimization of OSD formulations, focusing on scalability and process efficiency.
Isolator and Containment Management:
- Oversee the operation and maintenance of isolators and other containment systems, ensuring a contamination-free environment for high-potency oncology products.
- Implement and maintain stringent safety protocols for handling hazardous materials and highly potent compounds.
Operational Excellence:
- Drive continuous improvement initiatives across the site, leveraging Lean Six Sigma principles to enhance productivity, reduce waste, and optimize costs.
- Monitor key performance indicators (KPIs) and implement corrective actions to meet or exceed operational targets.
Cross-Functional Collaboration:
- Work closely with R&D, Quality Assurance, Supply Chain, and other departments to ensure seamless integration of new products into manufacturing.
- Collaborate with corporate leadership to align site objectives with overall business strategy.
Budget Management:
- Develop and manage the site's budget, ensuring cost-effective operations while maintaining high-quality standards.
- Approve capital expenditures and lead projects aimed at capacity expansion or technological upgrades.
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