Company Overview

Recruitment.

Job Description

We have the following career opportunity with one of our Pharma / Biotech client: Job Title: CEO / COO - Manufacturing, Drug Product (Bacterial & Viral Vaccines) Location: Bhubaneswar Reports to: Board of Directors Position Summary: The CEO/COO of Manufacturing for Drug Product (Bacterial & Viral Vaccines) will provide strategic leadership and oversight of sterile drug product manufacturing operations. This role is accountable for ensuring the safe, efficient, and regulatory-compliant production of bacterial and viral vaccine drug products, focusing on complex formulations, sterile filling processes, and isolator technology. The ideal candidate brings expertise in sterile injectables, aseptic filling, terminal sterilization, and equipment including isolators and Truking machines. This leader will drive operational excellence, foster a culture of continuous improvement, and build a high-performance manufacturing team. Key Responsibilities: • Strategic Leadership & Vision: o Set and implement the strategic direction for drug product manufacturing, aligning operations with company growth goals and regulatory requirements. o Define and execute the vision for operational excellence, quality assurance, and compliance in vaccine production. o Develop and lead high-impact initiatives in complex sterile injectable filling and formulation technologies to ensure innovation, efficiency, and competitive advantage. • Operational Oversight: o Lead the manufacturing organization, with accountability for all aspects of production, quality, and regulatory compliance in sterile drug product manufacturing. o Drive optimization in complex formulations and aseptic filling processes for bacterial and viral vaccines. o Ensure effective utilization and management of isolator technology, terminal sterilization, and Truking machines to achieve the highest standards in sterile manufacturing. • Regulatory Compliance & Quality Assurance: o Ensure all manufacturing activities meet or exceed GMP, FDA, EMA, and other relevant regulatory standards. o Lead audits, inspections, and regulatory interactions, ensuring a culture of compliance, continuous monitoring, and proactive quality management. o Oversee quality assurance and quality control, implementing corrective and preventive actions (CAPA) as necessary. • Financial Management & Resource Allocation: o Oversee budgets, financial planning, and resource allocation to meet financial and operational targets. o Identify and drive opportunities for cost optimization and efficiency improvements while maintaining high-quality standards in sterile drug product manufacturing. o Plan capital investments for facility expansions, technology upgrades, and equipment acquisition, especially for isolators, sterilizers, and filling machines. • Risk Management: o Assess and mitigate risks associated with production, equipment, and regulatory compliance, including contingencies for supply chain and operational continuity. o Implement robust risk assessment and management frameworks across aseptic filling and sterilization processes. • Team Leadership & Development: o Build, lead, and develop a high-performing, multidisciplinary manufacturing team, fostering a culture of excellence, safety, and continuous learning. o Establish clear goals and performance metrics to drive accountability and empower teams. o Promote diversity, equity, and inclusion within the manufacturing organization. • Cross-functional Collaboration & Stakeholder Engagement: o Work closely with R&D, Regulatory Affairs, Quality, and Commercial teams to ensure alignment on product development and launch timelines. o Establish strong relationships with key stakeholders, suppliers, and technology partners to secure resources, equipment, and expertise in isolator and sterilization technology. o Represent the organization at industry conferences and forums to enhance brand visibility and credibility in vaccine drug product manufacturing. Qualifications: • Education: Advanced degree (Master’s or Ph.D.) in Biochemistry, Biotechnology, Chemical Engineering, Pharmacy, Business Administration, or a related field. • Experience: o Minimum of 25 years of experience in sterile drug product manufacturing, with a focus on complex injectables, bacterial/viral vaccines, or biologics. o At least 10 years in a senior leadership role (CEO, COO, or VP of Operations) within a GMP-regulated, sterile injectable manufacturing environment. o Hands-on experience with isolator technology & terminal sterilization in vaccine production or similar biologic drug products. • Technical Knowledge: o In-depth understanding of aseptic filling, isolator systems, and sterile product manufacturing. o Expertise in FDA, EMA, and GMP regulations for sterile drug product production, especially with bacterial and viral vaccines. • Leadership Abilities: Demonstrated ability to develop and execute strategy, lead large teams, and drive operational efficiency in a complex manufacturing environment. • Analytical & Decision-making Skills: Proficient in data analysis, risk assessment, and problem-solving in sterile manufacturing contexts. • Communication Skills: Exceptional communication and presentation skills to engage effectively with the board, cross-functional teams, regulatory agencies, and industry stakeholders. .

Required Exp

Above 20 years yrs

Skill Required

The CEO/COO of Manufacturing for Drug Product (Bacterial & Viral Vaccines) will provide strategic leadership and oversight of sterile drug product manufacturing operations. This role is accountable for ensuring the safe, efficient, and regulatory-complian

Job Location

Bhuvaneshwar, India

Salary Package

$ 1Cr

Date of Job Posting

2024-12-06 14:24:39

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