India Job Openings
Harba Solutions
Manufacturing Lead - Downstream
Indianapolis
FULL TIME
September 18, 2024
- Lead the execution of downstream manufacturing activities such as clarification, chromatography, TFF, and filling, working collaboratively within a team.
- Serve as a liaison with downstream process development subject matter experts (SMEs) to stay updated on the latest processes and ensure seamless translation of these to the GMP manufacturing environment.
- Manage material supplies to ensure downstream manufacturing areas are stocked and ready for operations.
- Assist with the maintenance of laboratory equipment and support overall lab operations.
- Lead the creation, review, and revision of SOPs, batch records, and forms in collaboration with management, Process Development, and Quality Assurance teams.
- Provide clear direction to operators on downstream manufacturing processes and assist with training and coaching as needed.
- Accurately follow detailed instructions and ensure timely, precise documentation of all manufacturing activities.
- Maintain current training status and ensure compliance with all relevant policies and SOPs.
- Lead troubleshooting efforts for downstream manufacturing issues, working with Manufacturing Management when necessary.
- Train new team members and colleagues on downstream manufacturing processes.
- Conduct safety inspections and maintain a safe work environment.
- Perform sanitization of manufacturing areas and properly collect/dispose of waste.
- Collect process data for trending and metrics.
- Support GMP product optimization and improvements.
- Assist in specification development, review, and implementation through CAPAs and change controls.
- Bachelor’s degree in Biology, Biochemistry, Molecular Biology, or a related field.
- 2 years of experience in a GMP environment.
- 2 years of experience operating in a GMP laboratory using aseptic techniques and risk mitigation strategies.
- Experience with chromatography and TFF platforms.
- Experience in cell and gene therapy manufacturing or viral vectors is desired.
Pay: $32.00 - $34.00 per hour
Schedule:
- Day shift
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