Senior Scientific Officer- - Dera Bassi - Panacea Biotec

Description

Senior Scientific Officer/Scientific Officer- Quality Control- Electrophoresis and Chromatography lab

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

Experience: 3 to 7 years

Job Summary:

The Senior Scientific Officer/Scientific Officer- Electrophoresis and Chromatography Lab (Quality Control) will oversee the quality and efficacy of vaccine formulations at the Vaccine Drug Substance Plant, Lalru (Punjab). This position is responsible for ensuring the proper operation of HPLC, weighing balance, pH meter, densitometer, tube heating block, testing of CRM-197 Protein by HPLC and SDS Page, and other related tasks.

Responsibilities:

• Hands-on knowledge and experience in operating HPLC, weighing balance, pH meter, densitometer, and tube heating block.
• Hands-on experience in testing CRM-197 Protein by HPLC and SDS Page.
• Hands-on experience in testing Free Carrier protein by HPLC on HiBTT, HiBTi conjugate, and Pneumo conjugate.
• Hands-on experience in testing Molecular Size by HPLC on HiBTT, HiBTi conjugate, and Pneumo conjugate.
• Ensure online documentation as per good documentation practices.
• Experience in method validation for different products.
• Experience in evaluating LOD/LOQ for rinse samples.
• Verification of packing and consumables for the Production department.
• Testing of raw materials and release.
• Review of analytical data tested for HPLC and raw materials.
• Proficient in analytical procedures and analytical method validations.
• Monitoring of ongoing testing activities on the shop floor.
• Issuance of reference standards, retention samples, and stability samples.
• Review of analytical data, capable of analyzing raw data from HPLC, GC, spectrophotometer, etc.
• Right allocation of manpower in shift working and monitoring of assigned tasks with optimum output.
• Ensure quality and quantity of consumables, solutions with adequate usage and timely delivery to different manufacturing processes.
• Right and timely documentation, including SOPs, change controls, deviations, incidents, CAPA, risk assessments, in preview of PQS in view of regulatory guidelines and expectations.
• Ensure zero non-compliance and zero data integrity in documentation.
• Ensure regular maintenance of all equipment's of production by engineering to achieve zero-breakdown.
• Coordination with intra-departmental activities in compliance to support/execution.

Competencies Required:

• Effective Communicator.
• Motivate Team and Enable High Performance.
• Effective Performance Reviews of the Team and their Training.
• Must understand the team needs at the time of testing and sample preparation.
• Must understand Sterile Operations, Scientific practices, analytical techniques, and process criticalities of Vaccine manufacturing.
• Analytical approach – Good in trend analysis, data evaluation, and process calculations.
• Adequate, Timely, and Quality deliverance/Output within stipulated timeframe.
• Thorough understanding of PQS & its compliances with a risk-based approach.