Job Description

Roles & Responsibilities

To lead the innovation, process optimization, and product development initiatives related to state-of-the-art penicillin and 6-APA manufacturing. Oversee the formulation development, scale-up processes, technology transfer, and related regulatory compliance to enhance production efficiency, cost-effectiveness, and quality standards. Demonstrates a strong understanding of GMP requirements .

Tasks and Responsibilities:

• Manages the team to the level determined by Senior Management
• Lead and manage the R&D department, setting strategic goals aligned with business objectives.
• Develop and optimize fermentation, purification, and downstream processing techniques for penicillin and 6-APA production.
• Drive innovation in process improvement, ensuring cost reduction and yield enhancement.
• Oversee formulation development and product stability studies.
• Manage technology transfer from laboratory to full-scale production.
• Ensure compliance with GMP, FDA, WHO, and other regulatory requirements.
• Collaborate with cross-functional teams, including Quality Assurance, Production, and Regulatory Affairs.
• Conduct research on novel methods to improve antibiotic production efficiency.
• Keep abreast of emerging trends and technologies in pharmaceutical manufacturing.
• Mentor and develop R&D personnel, fostering a culture of innovation and continuous improvement.
• Identify training needs for laboratory staff and develop training programs to enhance team competencies in analytical techniques and best practices.
• Assist in the development and management of the analytical laboratory budget, ensuring efficient allocation of resources.

Desired Candidate Profile

Qualifications and Experience:

• PhD. or Master's degree in Biotechnology, Microbiology, Pharmaceutical Sciences, Chemical Engineering, or a related field.
• Minimum of 13+ years of experience in pilot plant operations or process engineering within the pharmaceutical or biopharmaceutical industry, with specific experience in penicillin production being a plus.
• Experience working in an international or multicultural environment is preferred.

Note: We thank all applicants for their interest, however only those candidates who are shortlisted will be contacted