Raspa is a biopharmaceutical company that is committed to reducing the cost of treatment for patients with cancer and other severe diseases. Our diverse and inclusive team is amalgamating technological innovation and automation strategies to make healthcare more accessible, affordable, and sustainable.
We are looking for someone with a zeal to set up, commission, and operate a Greenfield manufacturing facility for fermentation-based APIs. Leaving behind legacy ideas wherever relevant, the candidate is expected to bring to the table out- of-the-box ideas and be involved in all aspects of setting up and running a state-of-the-art unit.
You will:
- Be responsible for coordinating with the plant design team
- Conduct critical review of the facility layouts during initial design reviews
- Participate in system quality risk assessments for process critical systems
- Review initial system assessments and qualification lifecycle deliverables
- Participate in factory acceptance tests for process critical systems and equipment
- Actively assist in recruitment activities for the unit
- Drive all qualification activities under QA responsibility
- Oversee production activities including but not limited to planning, controlling, and troubleshooting (Scale up/ SAP/ Documentation) of various API's and related intermediates
- Create work plans including production planning and Inventory Control
- Review trend data with Operating Managers and Quality Assurance Manager
- Monitor process yield, solvent recovery and recycling, and production volumes
- Establish and review Operation excellence Metrics
- Ensure compliance with GMPs
- Ensure compliance with all Statutory and Legal requirements including Environment and Ecology, Health and Safety, Commercial, and Engineering
- Maintain the ZLD status of the unit
- Reduce unplanned down time by preventive and predictive maintenance, efficient inventory management, and annual maintenance contracts
- Maintain optimum manpower by implementing relevant automation
- Focus on energy conservation and improve processes to reduce carbon footprint
Our ideal candidate will have:
- An MBA degree with relevant experience of 10 years or more in managing a fermentation-based manufacturing facility
- Good understanding of WHO GMP practices
- Experience in handling Regulatory Inspections such as USFDA, EUGMP, and MHRA amongst others
- Knowledge of Plant Administration, Engineering, Safety, Technical services, and Technology Transfer
- Self-motivation with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description
- Ability to adapt to a fast-paced environment and to adjust workload based upon changing priorities
- Ability to work and collaborate in cross functional teams covering research and development, MSAT, and Production, amongst others in a fast pace and dynamic team setting
- A clear willingness to “roll up their sleeves” and dive into the details
Nice to have:
- Previous experience in planning and leading operations involving small to medium sized manufacturing units