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Biopharma
We have the following career opportunity:
Job Title: CEO / COO - Manufacturing, Drug Substance (Bacterial & Viral Vaccines)
Location: Bhubaneswar
Reports to: Board of Directors
Position Summary:
The CEO/COO of Manufacturing for Drug Substance, Bacterial and Viral Vaccines, is responsible for the strategic, operational, and financial leadership of the company's manufacturing operations, ensuring excellence in the production of high-quality bacterial and viral vaccines. This role involves overseeing all aspects of production, quality, compliance, and supply chain to deliver sustainable growth, regulatory compliance, and efficient operations. The CEO/COO will be a visionary leader with a deep understanding of biologics manufacturing, driving both operational success and long-term strategy in a competitive and highly regulated environment.
Key Responsibilities:
Strategic Leadership & Vision:
o Define and implement the company's strategic vision, goals, and objectives in vaccine manufacturing.
o Drive long-term planning, ensuring sustainable growth and alignment with the broader mission of public health and disease prevention.
o Oversee strategic partnerships and manage relationships with key stakeholders, including investors, regulatory bodies, and other industry leaders.
Operational Excellence:
o Lead the manufacturing organization, with full accountability for production, quality, and supply chain operations.
o Set and monitor KPIs to ensure the highest standards of efficiency, productivity, and quality within a GMP-compliant environment.
o Continuously improve production processes, introducing innovative manufacturing technologies and methodologies to increase capacity, yield, and cost-effectiveness.
Regulatory Compliance & Quality Assurance:
o Ensure that all manufacturing activities adhere to GMP, FDA, EMA, and other international regulatory standards.
o Oversee and prepare for regulatory inspections and audits, ensuring a culture of compliance and proactive quality management.
o Collaborate with Quality Assurance to lead root cause analyses and implement corrective and preventive actions (CAPA) when necessary.
Financial & Resource Management:
o Develop and oversee budgets, financial forecasts, and resource allocation to meet the organization's financial goals.
o Identify opportunities for cost optimization while ensuring the production of high-quality vaccine substances.
o Manage capital investments in manufacturing facilities, equipment, and infrastructure to support growth and innovation.
Risk Management:
o Proactively assess risks across production, supply chain, and regulatory areas, developing mitigation strategies.
o Develop contingency plans to address potential disruptions in production or supply chains, particularly in the context of vaccine manufacturing.
Team Leadership & Development:
o Build, lead, and mentor a high-performance leadership team, fostering a culture of continuous improvement, accountability, and safety.
o Drive initiatives to improve employee engagement, training, and development in line with company values and goals.
o Champion diversity, equity, and inclusion across the manufacturing organization.
Stakeholder & Cross-functional Collaboration:
o Collaborate with R&D, Regulatory Affairs, and Commercial teams to align manufacturing with product development and launch timelines.
o Maintain strong relationships with external partners, suppliers, and contract manufacturers to ensure seamless production and delivery of drug substances.
o Represent the organization at industry forums, conferences, and events to build brand visibility and position the company as a leader in vaccine manufacturing.
Qualifications:
Education: Advanced degree (Master's or Ph.D.) in Biochemistry, Biotechnology, Chemical Engineering, Business Administration, or a related field.
Experience:
o Minimum of 25 years in biologics manufacturing, with specific experience in bacterial and viral vaccine production.
o At least 10 years of experience in senior leadership roles (CEO, COO, VP Operations) within a GMP-regulated environment.
o Proven track record of driving operational efficiency, growth, and quality in a highly regulated industry.
Technical Knowledge:
o In-depth knowledge of vaccine production processes, bioreactor operations, and current Good Manufacturing Practices (cGMP).
o Expertise in regulatory compliance, quality systems, and best practices in large-scale biologics production.
Leadership Abilities: Strong strategic, operational, and financial leadership skills with a demonstrated ability to build and lead high-performing teams.
Analytical & Decision-making Skills : Ability to make data-driven decisions, manage complex manufacturing challenges, and solve technical issues in a fast-paced environment.
Communication Skills: Exceptional interpersonal and communication skills to engage with internal teams, external partners, regulatory bodies, and the board.
This role is ideal for a visionary leader passionate about advancing vaccine production capabilities, ensuring regulatory excellence, and making a meaningful impact on public health through innovative manufacturing processes.
WhatsApp your CV on 9133103335 along with Present & Expected CTC and notice period details.
Master of Public Health (MPH)
Date Posted: 21/11/2024
Job ID: 101048011