Senior Scientific Officer

Position Title : Senior Scientific Officer/Scientific Officer-Production- VBIII- USP

Educational Qualification : M.Sc. - Microbiology/Biotechnology, B.Tech- Biotechnology,

Experience : 3 to 7 years

Job Summary:

Senior Scientific Officer/ Scientific Officer shall be responsible for ensuring the quality and efficacy formulations at Vaccine Drug Substance Plant, Lalru (Punjab). This position will be responsible for Equipment handling i.e. Fermenters, Centrifuges, Process Vessels, TFF Systems, Weighing balances etc.

Shift Operations and Production Activities

Oversee and manage day-to-day production operations during assigned shifts, ensuring smooth workflow and adherence to production schedules.

• Ensure the completion of assigned tasks with optimum output and minimal downtime.

Equipment Handling and Operations

• Operate and monitor fermenters (up to 1500L scale), centrifuges (e.g., CSC-15, CSC-20), process vessels (up to 1000L), TFF systems.
• Handle large-scale weighing balances (up to 500 kg) and perform filter integrity tests.
• Ensure all laboratory equipment is in good working condition, conducting routine checks to prevent disruptions.

Quality Assurance and Compliance

• Conduct regular checks to ensure production quality, process consistency, and regulatory adherence.
• Liaise with Quality Assurance (QA) to address deviations, non-conformances, and ensure the release of high-quality products.
• Maintain compliance with regulatory requirements and documentation standards.
• Ensure online documentation in real-time, adhering to Good Documentation Practices (GDP).
• Maintain records for consumables, solutions, and other production-related items to ensure proper inventory control.

Cleaning, Sterilization, and Culture Handling

• Perform and supervise Clean-in-Place (CIP) and Sterilization-in-Place (SIP) operations.
• Manage inoculations and transfers of cultures with strict aseptic techniques.

Manpower Management and Shift Planning

• Allocate manpower effectively during shift operations to achieve maximum productivity.
• Develop and implement shift plans to ensure optimal utilization of available personnel.

Calibration and Maintenance

• Calibrate and maintain instruments such as pH meters, conductivity meters, and other critical equipment.
• Coordinate with the engineering team for regular maintenance and upkeep of production equipment.
• Monitor the quality and quantity of consumables and solutions, ensuring timely delivery to meet production demands.
• Minimize waste and optimize the usage of materials.

Competencies Required :

Aseptic Handling and Behavior : Deep understanding of aseptic techniques and behavior in a cleanroom environment. Ability to teach and enforce aseptic practices among team members to prevent contamination.

Quality Management System (QMS) :

Proficiency in managing QMS aspects, including:

Handling Events (deviations, non-conformances).

Managing Change Controls effectively to ensure compliance with regulatory requirements.

Implementation and tracking of Corrective and Preventive Actions (CAPA) .

Sterile Operations and Scientific Practices : Thorough knowledge of sterile manufacturing processes and critical scientific practices in vaccine production. Understanding the critical control points and process parameters to ensure product quality and sterility.

SAP Operations : Proficiency in SAP or equivalent systems for real-time posting of materials, tracking inventory, and handling final bulks.

Leadership Competencies

Team Motivation and High Performance : Ability to motivate team members and foster a high-performance culture. Encourage ownership, accountability, and collaboration within the team.

Effective Team Management : Lead, manage, and allocate tasks to team members to ensure efficient operation during shifts. Build a cohesive team, resolve conflicts, and maintain morale in high-pressure environments.

Performance Reviews and Training : Conduct regular and constructive performance reviews for team members. Identify skill gaps and implement targeted training programs to enhance team capabilities and ensure compliance with operational standards.