The Role
Execute upstream and downstream bioprocessing operations, including media and buffer preparation, fermentation, inoculum preparation, cell separation, lysis, filtration, and centrifugation. Maintain BMRs, logbooks, inventory, and process records. Coordinate equipment calibration, preventive maintenance, and AMC activities. Support process validation, commissioning, risk analysis, change control, incident and deviation management, CAPA, and root-cause analysis.
Summary Generated by Built In
Execution of job activity assigned by reporting authority.
Issuance of BMR followed by on time entries of processes and completion of BMR.
Executing operations on floor as per MFR as assigned.
On-time entries in logbook and BMR related to processing.
Provide oversight for execution of daily operations and maintenance inventory of supplies with the group.
Execution of upstream operation like WCB preparation and maintenance , Streaking, Media preparation, Buffer Preparation , CIP and SIP of equipments, fermenter Sterilization, Shake flask , Inoculum preparation, fermentation process , cell separation, Cell lysis, Inclusion Bodies preparation, Microfiltration ,Centrifugation, etc.
Responsibility of scheduling the instrument calibration, Equipment AMC, Preventive Maintenance and maintain related documents.
Good Knowledge about process validation, equipment Commissioning, Risk analysis, Change control, Incident, Deviation, CAPA and Route Cause analysis.
Issuance of Raw Materials (Chemicals/ Consumables/ Resins, etc.) and maintaining records of its consumption in process.
Skills Required
- Knowledge of upstream bioprocessing operations, including WCB, media, buffer, inoculum, shake flask, and fermentation processes
- Knowledge of downstream processing, including cell separation, cell lysis, inclusion bodies preparation, microfiltration, and centrifugation
- Knowledge of CIP, SIP, fermenter sterilization, and bioprocess equipment operations
- Knowledge of process validation, equipment commissioning, and risk analysis
- Knowledge of change control, incident and deviation management, CAPA, and root-cause analysis
- Ability to maintain BMRs, logbooks, inventory records, and process documentation
- Ability to schedule equipment calibration, AMC, and preventive maintenance
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The Company
What We Do
Yashraj Biotechnology Limited develops and manufactures high-purity native and recombinant protein biomarkers for diagnostic applications. Established in 1999, the company also addresses preclinical drug-discovery needs and operates as an emerging contract research organization specializing in preclinical research. Its biotechnology solutions support diagnostic development and related life-science workflows, with operations headquartered in Mumbai and offices in the United States and Germany for international customers.
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