Site Head

Job Description: Site Head - Oncology OSD Formulation Site

Position Title: Site Head - Oncology OSD Formulation Site
Location: Baroda, Gujarat, India
Department: Manufacturing
Reports To: Director Technical Operations.
Job Type: Full-time

Job Summary:

The Site Head - Oncology OSD Formulation Site will be responsible for overseeing all operations at the Baroda facility, ensuring the production of high-quality oncology products for regulated markets. This role demands a leader with a deep understanding of oncological formulations, particularly Oral Solid Dosage (OSD) forms, and extensive experience in managing isolators and containment systems in a highly regulated environment. The incumbent will ensure compliance with global regulatory standards, drive continuous improvement initiatives, and lead cross-functional teams to achieve operational excellence.

Key Responsibilities:

1. 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.
2. 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.
3. 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.
• 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.
4. 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.
5. 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.
6. 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.

Qualifications:

• Education: Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or a related field. A PhD is preferred.
• Experience: Minimum 15 years of experience in pharmaceutical manufacturing, with at least 10 years in a leadership role within an oncology-focused facility.
• Regulatory Knowledge: Extensive experience with regulatory submissions and audits for regulated markets (e.g., US, EU).
• Technical Skills: Deep expertise in Oncology OSD formulations, isolator technology, and high-potency product handling.
• Leadership Skills: Proven ability to lead large teams, manage cross-functional projects, and drive operational excellence.
• Certifications: Lean Six Sigma certification or equivalent is preferred.