Intern (MECOP)

AGC Biologics•Bothell, WA

1d•$27 - $29

About The Position

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. JOB SUMMARY We have an opportunity for an Intern (MECOP program required) to join AGC Biologics. This position requires technical problem-solving and inter-departmental collaboration and will be responsible for assisting with the transfer and implementation of new technologies and systems to support GMP operations.

Requirements

Working knowledge of biologics manufacturing unit operations such as Cell Culture, Fermentation, Viral Inactivation, Chromatography, Viral Filtration, and Tangential Flow Filtration.
Working knowledge of current Good Manufacturing Practices (cGMPs).
Conceptual understanding of single-use technologies and aseptic processing.
Must be self-motivated, organized, and proactive.
Demonstrated ability to interface/communicate extensively with internal and external clients.
Ability to coordinate multi-departmental tasks and deliverables (interaction with Manufacturing, Process Development, Engineering, QA, QC, etc.).
Proven experience successfully managing multiple projects simultaneously.
Demonstrated ability to build effective working relationships across departments (Manufacturing, QA, Process Development, Project Management, Business Development, etc.) to support processes and products.
Demonstrated experience leading troubleshooting efforts.
Actively working towards a degree in a related engineering and/or scientific discipline.
Completed a minimum of 2 years of undergraduate coursework.
Concurrent coursework in related areas such as process control, microbiology, biochemistry, bioprocess design, bioreactors/bioseparations, statistical data analysis, etc.
Fundamental understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
Must have strong technical writing and data presentation skills.
Applicants must be enrolled in the MECOP internship program to be considered.

Nice To Haves

Understanding of Equipment onboarding and Life Cycle Management in a GMP setting is a plus.

Responsibilities

Lead special projects as assigned focused on improved technology, manufacturing reliability, documentation workflows, and/or data analysis.
Support Staff Scientists/Engineers on project teams as needed to deliver on implementation of new equipment and technologies.
Actively support process optimization and implementation of strategies for improving Upstream/Downstream unit operations throughout the product lifecycle.
Monitor ongoing processing, leading troubleshooting efforts as required, collection, and analysis of run data.
Network with various departments as required to ensure project deliverables meet the needs of all stakeholders across the organization.
Participate in the review and analysis of manufacturing campaign data trending, and present daily progress, as well as end-of-campaign summary updates.
Support emergent events response for on-floor manufacturing issues.
Generate and maintain documents related to GMP Manufacturing executions, product impact assessments, and campaign summary reports.
Participate in the project team meetings, decisions, and creation of milestones representing your assigned department.
May prepare and present data associated with manufacturing processes to internal and external clients.