Senior Contamination Control Strategist at Biogen in Research Triangle Park, North Carolina

Job Description:

Job Description

About This Role

As the Senior Manufacturing Scientist specializing in Contamination Control Strategy, you will be responsible for the oversight and maintenance of the Microbial Contamination Control Strategy (CCS) at Biogen's Research Triangle Park - Bio Site. Reporting to the Site Head of Manufacturing Sciences, your expertise in microbiology and facility controls will play a crucial role in identifying and controlling microbial risks for our drug substance production processes. This role offers a unique opportunity to drive continuous improvement and collaboration within a dynamic environment.



What You'll Do

* 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 matter

* Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement



Who You Are

You are a passionate microbiologist or engineer who strives for continuous improvement within biologics manufacturing and contamination control. Your collaborative nature allows you to effectively build and lead cross-functional teams, and you thrive in roles where you can shape and define the responsibilities. #LI-CC1

Qualifications

Required Skills

* 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 DS or DP manufacturing operations

* Experience with microbiological risk assessments

* 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

Preferred Skills

* M.S. with 6+ years' experience or Ph.D. with 2+ years' experience in the Biotech/Biopharma industry

* Proven track record of successful execution in a fast-paced environment, collaborating across corporate functions and multiple stakeholders

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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.