Sumitomo Pharma Co., Ltd

Manufacturing Associate II

Morrisville, NC · Mid

Sponsorship not specified$20k-$25kDetected 1 day ago

AccessibilityRecruitingGMPCell CultureResearchCommunicationProblem SolvingOSHA

About the role

With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.
For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.

Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Observes and performs critical processing steps and provides real-time feedback.
Create, redlines, and reviews process Standard Operating Procedures (SOPs).
Develop a suitable level understanding of Sumitomo Pharma America, Inc
Performs inventory control and cycle counts.
Performs alarm monitoring and reconciliation.
Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the production floor.
Collaborates with stakeholders and customers to resolve production-related issues.
Develop a Subject Matter Expert (SME) level understanding of Sumitomo Pharma America, Inc.'s GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.

Must be able to exercise appropriate judgment as necessary.
Excellent written and oral communication skills required.
Requires ability to use a personal computer for extended periods of time.
Must be able to travel domestically and internationally as needed.
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.
Attends and actively participates in waste walkthroughs, 5S, kaizen events, lean six-sigma, quality, safety, or environmental training/initiatives, as required.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

This listing is sourced directly from Sumitomo Pharma Co., Ltd's careers page and normalized into a canonical job model.