What are the responsibilities and job description for the Process Engineer Lead position at AmplifyBio?
About Us
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work to preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike. We have recently expanded into manufacturing services for cell, gene, and mRNA-based therapeutics.
Our Mission
We are committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.
About the Role
We are seeking a highly skilled Process Engineer/Senior Process Engineer to join our Manufacturing Science and Technology (MSAT) team. This role will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.
Key Responsibilities
Manage the transfer of CGT manufacturing processes from clients into the AmplifyBio GMP facility.
Provide leadership and training of the manufacturing staff on cell and gene manufacturing processes and equipment.
Support the manufacturing staff during technical transfer, start up, and in routine processing.
Work effectively with other operational groups to ensure that all GMP requirements are met for the implementation of processes into the AmplifyBio facility.
Coordinate manufacturing timelines and deliverables through Joint Project Teams, Program Management, and other functions as appropriate.
Requirements
BS, MS, or PhD degree in engineering or scientific field plus at least 6 years of experience.
Minimum of 6 years of experience in Manufacturing or Development roles with more than 2 years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company.
Knowledge and experience in transferring a process into a new facility.
Experience with aseptic processing, cell and/or gene therapy manufacturing.
Experience in leading meetings, teams, and projects.
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