President, Operations

Raspa Pharma Pvt. Ltd.; Lucknow; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Raspa Pharma Pvt. Ltd. seeks a senior professional to set up and run a Greenfield fermentation API manufacturing facility in Lucknow. You will coordinate with the plant design team, review layouts, and drive QA/validation to ensure GMP-compliant operations.

The ideal candidate has an MBA with 10+ years in fermentation manufacturing, with exposure to regulatory inspections (USFDA, EUGMP, MHRA) and cross-functional leadership.

Qualifications

• MBA or equivalent with biotech operations focus.
• Experience managing a fermentation-based manufacturing facility.
• Strong understanding of WHO GMP practices.
• Experience handling regulatory inspections (USFDA, EUGMP, MHRA).
• Knowledge of plant administration, engineering, safety, and technology transfer.
• Demonstrated ownership and adaptability in fast-paced environments.
• Ability to lead cross-functional teams including R&D, MSAT, and Production.

Responsibilities

• Coordinate with the plant design team during greenfield setup.
• Review facility layouts and design reviews.
• Participate in QA risk assessments for critical systems.
• Lead qualification lifecycle activities and document control.
• Support factory acceptance tests for critical equipment.
• Assist in recruitment and manpower planning for the unit.
• Oversee production planning, control, and troubleshooting of APIs and intermediates.
• Drive energy conservation and implement automation to optimize operations.
• Ensure GMP compliance and adherence to regulatory requirements.

Skills

Leadership & team management

Cross-functional collaboration

Regulatory compliance mindset

Strategic planning

Quality risk assessment

Education

MBA or equivalent with biotech operations focus

Tools

SAP

Job description

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