Posted in Information Technology 22 days ago.
Type: Full Time
Location: Research Triangle Park, North Carolina
Job Description
About This Role
This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be responsible for the strategic and tactical oversight of batch documentation review, continual evaluation during batch production, as well as providing material acceptance decisions for production batches. Through your guidance, your team will ensure compliance to all applicable regulatory requirements and that all GMP activities consistently operate in a state of control so as to successfully undergo domestic and international regulatory agency scrutiny.
What You'll Do
Who You Are
You are an experienced and energetic leader that enjoys leading a Quality Assurance organization through deadline driven initiatives. You are unfazed by the challenges of a complex manufacturing floor and can effectively plan, communicate, and advocate for a "Quality Mindset" throughout all of operations.
Qualifications
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. Read on 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.
PDN-9bfdaedc-e963-40a5-9062-74d1c99f85d9
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