Chemist (479974)
Apply NowCompany: Futran Tech Solutions Pvt. Ltd.
Location: Belmont, CA 94002
Description:
Job Description:
Bachelor's degree in chemistry with 2-year R&D experience in Medical Device and Biotechnology Industry.
Experience in Organic Synthesis, Polymer Chemistry, Raw Material Management, Materials Testing.
Experience in GLP/GMP Manufacturing Procedure and Documentation.
The LTTS onsite engineer will broadly participate in the following activities:
Scaling up the IOL development processes and operations at the Belmont, CA facility to integrate and support build of design verification and validation samples. Design verification samples will be used to conduct preclinical testing - a prerequisite to start clinical study. Design validation samples will be used to conduct clinical study. Scale up and remediation activities will be required to meet capacity requirement and Customer standards at the Belmont facility.
Support integration and scale up of supplemental (second) pilot manufacturing line in Fort Worth, TX to build design verification and validation samples. This effort will be focused on remediate the lower capacity of existing manufacturing line in Belmont, CA.
Remediate and development of higher scale manufacturing processes in Fort Worth, TX to meet sample demands for product registration and further remediate the lower capacity of the existing process in Belmont, CA. Enhancement to process to be shared cross site to meet development/manufacturing needs."
Bachelor's degree in chemistry with 2-year R&D experience in Medical Device and Biotechnology Industry.
Experience in Organic Synthesis, Polymer Chemistry, Raw Material Management, Materials Testing.
Experience in GLP/GMP Manufacturing Procedure and Documentation.
The LTTS onsite engineer will broadly participate in the following activities:
Scaling up the IOL development processes and operations at the Belmont, CA facility to integrate and support build of design verification and validation samples. Design verification samples will be used to conduct preclinical testing - a prerequisite to start clinical study. Design validation samples will be used to conduct clinical study. Scale up and remediation activities will be required to meet capacity requirement and Customer standards at the Belmont facility.
Support integration and scale up of supplemental (second) pilot manufacturing line in Fort Worth, TX to build design verification and validation samples. This effort will be focused on remediate the lower capacity of existing manufacturing line in Belmont, CA.
Remediate and development of higher scale manufacturing processes in Fort Worth, TX to meet sample demands for product registration and further remediate the lower capacity of the existing process in Belmont, CA. Enhancement to process to be shared cross site to meet development/manufacturing needs."