Responsibilities :
- Participates in process sustaining, definition and improvement, design, development, and quality test activities under general instruction.
- Troubleshoots production line issues related to yield, quality, and throughput.
- Participates in establishing operating equipment specifications and improvements
- Constructs and executes controlled experiments to address yield and quality issues and drives implementation of solutions in a production environment to meet production goals
- Conducts controlled process optimization experiments for release into production environment
- Works cross functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing products
- Defines technical requirements and procedures for manufacturing to process product
- Organizes and participates in required execution of validation protocols and drive the release of the corresponding report
- Participate in process design, development, definition, and quality test activities in the making of consumable products or support of processes / equipment used to sequence genomes.
Requirement :
- Technology transfer and continuous improvement experience
- Ability to write / report Protocols, reports, SOP'S, work instructions, etc.
- Design D modeling using CAD, create drawings and partner with vendors for prototype / production
- Support Deviation Management
- Understanding of cGxP principles and practices
- ISO ,
- Experience in API final form definition
- Proven leadership experience (projects, people, labs)
- Experience related to upstream and / or downstream process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP)
- MS in Biotechnology, or related field with at least years of bio pharmaceutical process development and manufacturing experience
- Associate degree / Certificate / Diploma in laboratory science
- Strong technical knowledge and hands on experience with biological manufacturing
- Looking for someone with a background in Chemistry scale up or chemistry processes from a regulated Medical Device environment.
- Polymer Science background
- Experience synthesizing polymers and understands the polymerization process.
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Participate in process design, development, definition, and quality test activities in the making of consumable products or support of processes/equipment used to sequence genomes. Participates in process sustaining, definition and improvement, design, development, and quality test activities under ...
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