Senior Contamination Control Strategist

2 weeks ago

Denver, Colorado, United States Biogen Full time
About This Role

We are seeking a highly skilled Senior Contamination Control Strategist to join our team at Biogen. As a key member of our manufacturing sciences group, you will be responsible for overseeing and maintaining our Microbial Contamination Control Strategy (CCS) at our Research Triangle Park - Bio Site.

Key Responsibilities
  • Maintain the site Contamination Control Strategy (CCS), managing gap assessments and risk assessments related to Annex 1 and CCS compliance
  • Participate in new product introduction teams as the contamination control SME
  • Lead initiatives and strategy development related to site CCS
  • Establish and maintain analytics and KPI reporting methods for site Bioburden Contamination Control performance
  • Participate in root cause investigations for microbiological and manufacturing nonconformances
  • Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews
  • Create, execute, and/or review technical documents and change controls related to contamination control strategy
  • Support inspection readiness plans and interact with regulatory agencies during inspections on Microbial Contamination Control program related matters
  • Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement
Requirements
  • BA/BS with 8+ years' experience in the Biotech/Biopharma industry
  • Strong understanding of microbiology, aseptic processing, contamination control practices, and engineering controls for biologics Drug Substance or Drug Product manufacturing operations
  • Comprehensive knowledge of global GMP regulatory requirements for biologics manufacturing
  • Experience interfacing with inspectors/regulators
  • Strong analytical skills with excellent written and oral communication skills
  • Proven experience leading cross functional matrix programs
Preferred Qualifications
  • M.S. with 6+ years' experience or Ph.D. with 2+ years' experience in the Biotech/Biopharma industry
  • Experience with microbiological risk assessments
  • Proven track record of successful execution in a fast-paced environment, collaborating across corporate functions and multiple stakeholders
About 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.

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.

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