Kyowa Kirin North America
Manager, Solutions Prep
Sanford, NC
Sponsorship not specified$125k-$155kDetected 36 days ago
Stakeholder ManagementERPGMPCell CultureLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft OfficeLean Manufacturing
About the role
- A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.
- Escalate issues that cannot be resolved. - Troubleshooting and Collaboration: Use the Continuous Improvement loop to identify related issues.
- Work with Process Engineers, MS&T, Maintenance, and QA to resolve these issues.
Responsibilities
- Provide project and program management expertise during the initial design and construction phase of the project.
- Provide technical leadership and operational support across multiple Drug Substance manufacturing functions, including Solutions/Buffer Preparation and Upstream Manufacturing.
- Partner with Upstream Manufacturing, MS&T, Engineering, Maintenance, and Quality teams to ensure seamless manufacturing operations across Drug Substance functions.
- Deliver on KPIs and communicate KPI and batch status at Tier meetings.
- Understand and implement Lean Manufacturing principles to maintain process equipment in a compliant manner.
- Set clear priorities and drive execution against key operational objectives.
- Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within established timelines.
- Support operational readiness, startup activities, and continuous improvement initiatives in a dynamic manufacturing environment.
Nice to have
- Associate's degree or Bachelor's degree in Physical Sciences, Engineering, or a related Life Sciences field is required.
- Minimum 7 years of experience plus an Associate's degree OR minimum 5 years of experience plus a Bachelor's degree
- Relevant pharmaceutical Drug Substance (DS) manufacturing experience
- Experience in Solutions/Buffer Preparation manufacturing
- Experience supporting, leading, or collaborating with upstream biopharmaceutical manufacturing operations.
- Working knowledge of upstream manufacturing processes, including cell culture, bioreactor operations, harvest activities, and process monitoring.
- Experience working across multiple Drug Substance manufacturing functions, including Solutions/Buffer Preparation and Upstream Manufacturing
- Experience implementing Lean Manufacturing principles
Skills
- Proficiency with ERP systems is a plus
- Proficient in MS Office Suite
- Working knowledge of upstream bioprocessing operations and associated manufacturing systems.
- Non-Technical Skills
- Physical Demands
- Initially working on a construction site and ultimately in a biopharmaceutical manufacturing facility in Sanford, NC.
- Work is 100% on-site in Sanford, NC. This is not a hybrid or remote position.
Compensation
- The anticipated salary for this position will be $125,000 to $155,000.
Visa & Work Authorization
- ability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law
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