- Leading and/or supporting supply chain deviations and investigation write-ups
- Implement Process Improvement projects- focused on efficiency and Operational Excellence.
- Project management and project execution – lead or participate in projects (moderate to complex in nature), facilitating timely execution.
- Develop, manage, and execute process improvement projects in site-based supply chain
- Partner with cross functional groups (e.g. Supply Chain, Manufacturing Sciences, Engineering, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
- Maintaining the Site Supply Chain KPI dashboards and identifying any corrective actions
- Initiate, own, and manage Site supply chain focused change controls, CAPAs, and planned exceptions
- This site-based role supports Site Supply Chain, primarily during core weekday business hours, but may require infrequent off-hours support.
- Bachelor's degree (Engineering, Supply Chain, Finance preferred) plus 1 year of transferrable experience
- Associates Degree or BioWork Certificate plus 2 years of transferrable Experience
- High School Diploma (or Equivalent) plus 4 years of transferrable experience
- Intermediate to advanced skills in Microsoft Office and computer-based quality systems
- Excellent oral and written communication skills
- Prior experience in site supply chain operations in drug substance/biologics manufacturing
- Training with Lean Six Sigma tools
- Leading or supporting Process Improvement Initiatives
- Understanding of business processes and roles of cross-functional groups supporting site supply chain operations
- Process improvement experience
- Process Mapping for complex, regulated manufacturing operations
- Robust understanding of quality and cGMP principles
- Fundamental knowledge of change control in cGMP environment
- Intermediate to advanced level of technical writing skills
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Process Excellence Analyst - Durham, United States - Biogen
Description
Job Description
About this Role
In this Process Excellence Analyst role, you will be responsible for leading/supporting process improvement initiatives, Site Supply Chain Deviations Investigations, supporting the implementation of effective CAPAs and monitoring key site supply chain KPIs. This position requires you to be highly detail-oriented with excellent technical writing skills and a continuous improvement mindset.
What You'll Do
Who You Are:
A highly detailed and focused individual who demonstrates a moderate to advanced level of technical process knowledge, technical writing ability, and subject matter expertise with site supply chain processes and equipment, as well as a robust working experience within highly regulated manufacturing environments. This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.
Qualifications
Required Skills:
Preferred Skills:
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
