Biogen
Senior Contamination Control Strategist
Biogen, Denver, North Carolina, United States, 28037
Company Description
Job Description
About This RoleAs 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, manufacturing, 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 matters• Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement
Who You AreYou are a passionate scientist 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 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 Skills• 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
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.
Videos To Watchhttps://youtu.be/S8n1OGEJWr0
Job Description
About This RoleAs 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, manufacturing, 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 matters• Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement
Who You AreYou are a passionate scientist 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 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 Skills• 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
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.
Videos To Watchhttps://youtu.be/S8n1OGEJWr0