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