Lambda is a global Contract Development & Manufacturing Organization (CDMO) offering integrated biologics development, GMP manufacturing, and First-in-Human (FIH) trial capabilities. With advanced facilities, scalable equipment trains, and a strong focus on quality and regulatory excellence, Lambda supports end-to-end biologics development for global clients.
Key Responsibilities
As a Senior Officer – QC Microbiology, your responsibilities will include:
- Conduct robust analytical methods including Sterility, BET, Bioburden, water analysis, and method validation.
- Perform environmental monitoring for development and GMP manufacturing areas.
- Manage microbiological media receipt, storage, maintenance, and preparation.
- Execute in-process and finished product microbiological testing.
- Maintain documentation as per GDP standards.
- Handle microbial cultures, biological indicators, and organism identification.
- Manage waste disposal and biohazard discard processes.
- Prepare water trends, annual summaries, and QC reports.
- Prepare and review URS, SOPs, and qualification protocols.
- Operate, qualify, and maintain microbiology lab instruments and equipment.
- Plan and execute microbiology testing and environmental monitoring schedules.
- Maintain lab data, logbooks, equipment records, and calibration logs.
- Coordinate with cross-functional teams for sampling, media requirements, and testing needs.
- Support implementation of new technologies for process intensification.
- Ensure compliance with EHS, GMP, GLP, and data integrity standards.
- Support internal, client, and regulatory audits.
- Handle Deviations, CAPA, LIR, Change Controls, OOS, OOT, and QMS documentation.
- Review reports for sterility, MLT, BET, GPT, environmental monitoring, and water testing.
- Train and qualify analysts under the microbiology training program.
Required Qualifications
- Education: M.Sc. in Microbiology / Biotechnology
- Experience: 2 to 6 years in QC Microbiology, preferably in a biologics or pharmaceutical GMP environment
- Strong understanding of ICH, USP, GLP/GMP guidelines
- Hands-on experience in microbial testing and lab instrumentation
CTC / Salary Range
INR 3,00,000 – 6,00,000 per annum (as provided)
Job Location
📍 Ahmedabad, Gujarat, India
Why Join Lambda Therapeutic Research?
- Opportunity to work in a global CDMO environment
- Exposure to advanced biologics and GMP microbiology workflows
- Career advancement through structured training and analyst qualification
- Experience with international regulatory audits (USFDA, EMA, MHRA, etc.)
- Collaborative work culture and modern laboratory infrastructure