Job Title:  Senior Officer - QC Microbiology Lab

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research Ltd. is positioning the “Contract Development & Manufacturing Organization (CDMO)” in its vision to serve as an integrated solutions provider for biologics drug development, GMP manufacturing, and to enable First in Human (FIH) clinical trials globally.Our flexible capacity and equipment trains, combined with our agile, collaborative approach, give us the ability to scale up any biologic product for each unit operation – from pilot batch to clinical quantities – to accelerate the time to file and market.In this integrated offering, the following cutting-edge technical functions will be fully engaged in providing end-to-end support to our customers in bolstering the development pathway for their lead biologics/bio-therapeutics or biosimilars, ensuring quality, precision, and success. 

JOB DETAILS

• Accountable for robust analytical methods (Sterility, BET, Bioburden) Environmental monitoring and Water analysis and their method validation.
• Responsible for environmental monitoring of the development and GMP manufacturing area.
• Microbiological media receipt, storage and maintenance of prepared media.
• Perform routine laboratory in-process and finished sample analysis.
• Documentation of all microbiological activities as per GDP.
• Responsible to handling the microbial culture, biological indicator and identification. Responsible of discard and waste management.
• Preparation of water trend, annual summary reports.
• Responsible for the preparation and review of user requirement specification (URS) and standard operating procedure (SOP).
• Equipment qualification for QC microbiology Laboratory.
• Operation & maintenance of instruments and equipment used for testing of QC microbiology lab samples.
• Planning and execution of microbiology sample testing and environmental monitoring.
• Updating daily laboratory generated data into laboratory records and maintenance of laboratory instruments and logbooks. 
• Coordination with cross functional team for sample submission and maintain the requirement of media and material required for testing and monitoring.
• To learn about newer technologies and implement them for process intensification.
• Ensure all assigned mandatory training related to data integrity, health and safety measures are completed on time by all members of the team including self.
• Ensuring of self, teams and lab/plant as per safety requirement and following environment, health and safety (EHS) requirements at all times in the workplace.
• Supports in internal Audits, Client audits and regulatory Audits pertaining to CDMO Lambda.
• Overseeing and maintenance of the microbiology lab including thorough documentation on the performance of all analytical equipment.
• Responsible for analytical method qualification and validation from various regulatory agencies, ICH, USP chapters as well as requirements of working in GLP/ GMP environment.
• Identify and communicate best practices within the CDMO function and communication and follow up with external testing laboratory.
• Effective implementation of training program and Analyst Qualification in Microbiology Laboratory
• Handling of Deviations, CAPA’s (assessment of effectiveness), LIR’s, Change Controls, Out of Specification (OOS), Out of Trend (OOT), and other relevant QMS documents related to Microbiology lab.
• Review of Microbiology reports like Sterility, MLT, BET and Water testing, media preparation, GPT, environmental monitoring etc.
• Any other responsibility as assigned by the HOD, based on knowledge and training.

EXPERIENCE

2 to 6 years

EDUCATIONAL QUALIFICATION

M SC Microbiology/Biotechnology.