Job Title: Assistant Manager - BBM
Purpose of Job
Responsible for dispensing, media / buffer preparation and execution of Downstream processing in manufacturing area for commercial production, validations, engineering, clinical batches and related documentation.
Skill Required
Required knowledge on commercial scale Chromatography system, columns and TFF systems
Roles and Responsibilites
Responsible for general area cleanliness, sanitation, cGMP compliance of facility as per cGMP procedure and compliance to bio safety policies.
Execution of media and buffer preparation activities as per BPCR.
Execution, processing and supervision of Downstream operations for all commercial, engineering, clinical and validation batches as per production schedule.
Authorized person for reviewing of all documents, reviewing of batch records and documentation of batches as per SOPs and written procedures.
Preparation & revision of equipment and process related SOPs as per current operations.
Qualification of new equipment’s, preparation and execution of Qualification documents (URS, DQ, IQ, OQ and PQ).
Responsible for execution of equipment’s PV and ensuring proper preventive maintenance of equipment’s.
Relevant skills / Industry experience
Required knowledge on commercial scale Chromatography system, columns and TFF systems having 6-10 years of experience
Biotech, Ahmedabad, GJ, IN, 382213