location_onPune, Maharashtra, India
watch_later Posted: Feb 26, 2024
Skills Required
Nice To Have skills
Job Description
About the job
Job Description: Microbial (DSP):
We are looking for a Senior Executive/ Executive for Microbial Manufacturing unit located at Pune.
Technical Responsibilities :
- Execute and operate upstream manufacturing batch activities
- Operate process equipment like AKTA process, TFF system, Filter Integrity check machines, autoclave, Column packing station, etc.
- Manage all chromatography steps, UFDF steps and sterile filtrations
- Manage buffer preparation and filtration activities
- Maintaining Quality Management Systems related documentation like - deviations, change controls, risk assessment documents etc.
- Monitoring of batch performance and data
- Hands-on experience with single-use mixers
- Experience in equipment qualification and validations
- Proper documentation of batches as per SOP and written procedures
GMP compliance:
- Apply Good Manufacturing Principles in all areas of responsibility
- Follow environment, health, and safety (EHS) requirements in the workplace
- Ensuring compliance to cGMP in area as defined by SOPs
Skills Required:
- Working in a cGMP environment.
- Experience in e.coli based biopharmaceutical production processes
- Capability to work in a team and ability to handle demonstrate a good team spirit
- Strong interpersonal skills are required with the ability to work cross-functionally with internal and external customers
Minimum Requirements – Education and Experience:
M.Tech/M.Sc in Biotech/ Biochemistry with 3-7 years of experience working in Microbial manufacturing.