
Kemwell Biopharma
Urgently Required
Chief Manufacturing Officer
Experience : 1 to 5 years
No of vacancies : 1
Job Description: The Chief Manufacturing Officer (CMO) in the Indian pharmaceutical industry is a senior executive responsible for overseeing large-scale manufacturing operations, ensuring compliance with Indian regulatory standards (CDSCO, Schedule M) and global guidelines (WHO-GMP, USFDA, EMA). The CMO drives strategic initiatives to improve efficiency, maintain high-quality production, and achieve operational excellence across multiple facilities while supporting the company’s business and export goals.
Key Responsibilities: Manufacturing Strategy: Develop and implement strategies to optimize manufacturing operations across Indian facilities and export markets.
Regulatory Compliance: Ensure compliance with CDSCO, Schedule M, WHO-GMP, and international standards like USFDA, EMA, and MHRA.
Process Optimization: Lead initiatives to enhance operational efficiency and reduce costs using Lean, Six Sigma, and automation technologies.
Quality Assurance: Oversee quality control and assurance processes to meet Indian Pharmacopeia (IP) and international pharmacopeia standards.
Multi-Site Management: Supervise production across multiple manufacturing sites, ensuring uniformity in standards and processes.
Supply Chain Integration: Collaborate with supply chain teams to ensure seamless material flow, inventory management, and timely delivery.
Team Leadership: Build and lead high-performing cross-functional teams, including production, quality, supply chain, and EHS.
Innovation: Drive adoption of advanced manufacturing technologies like AI, robotics, and IoT for enhanced scalability and efficiency.
Regulatory Audit Readiness: Prepare for and manage inspections by Indian and global regulatory authorities, including CDSCO, USFDA, EMA, and WHO.
– Stakeholder Collaboration: Work closely with R&D, regulatory affairs, and marketing teams to align manufacturing with product pipelines and market demands.
Sustainability: Promote sustainability and environmental compliance in manufacturing operations.
Education Qualifications: Minimum Requirements: Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, or Manufacturing Operations.
Preferred: Master’s degree in Business Administration (MBA) or Pharmaceutical Technology.
Certifications: Certifications in GMP, WHO-GMP, Lean Six Sigma, or Project Management. Knowledge of Indian regulatory standards like CDSCO and global regulatory frameworks is essential.
Key Attributes: Regulatory Expertise: In-depth understanding of Indian pharmaceutical regulations and international compliance standards.
Strategic Vision: Ability to align manufacturing operations with long-term business goals.
Leadership: Proven experience in managing large teams and multi-site operations in a complex regulatory environment.
Problem-solving: Analytical skills to address manufacturing challenges effectively.
Innovation-Driven: Commitment to adopting new technologies for process improvement.
About the Role: The Chief Manufacturing Officer plays a pivotal role in ensuring the pharmaceutical company’s manufacturing capabilities align with domestic and international regulatory requirements while supporting the organization’s business goals. This role involves overseeing large-scale production, driving process improvements, and maintaining quality standards. The CMO is integral in steering the company’s manufacturing operations to meet market demands, achieve scalability, and maintain a competitive edge.