Job Description
About This Role
As the Sr Manufacturing Control Specialist III, you will be responsible for the oversight and maintenance of the risk assessments and technical assessments at Biogen's Research Triangle Park - Pharma Site. Reporting to the Head of Manufacturing - ASO and OSD, your expertise in microbiology, manufacturing, and facility controls will play a crucial role in identifying and controlling product, microbial, and viral contamination risks for our manufacturing production processes as well as supporting investigations and conformances. This role offers a unique opportunity to drive continuous improvement and collaboration within a dynamic environment across Parenteral Filling (PF), Oral Solid Dose (OSD) and Antisense Oligonucleotide (ASO) manufacturing.
What You'll Do
- Support the site's Contamination Control Strategy (CCS), managing gap assessments and risk assessments related to Annex 1 and ensuring CCS compliance
- Participate in new product introduction teams including change control review board requirements
- Lead and author risk assessments to prevent product cross-contamination, ensuring documented according to ICH guidance
- Lead initiatives and strategy development related to site CCS
- Establish and maintain analytics and KPI reporting methods for site Bioburden Contamination Control performance, including Environmental Monitoring Review Board Participation and Action Lead
- Participate and/or Lead the 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 Contamination Control program related matters
- Perform routine GEMBA assessments of manufacturing operations including identification of deficiencies and opportunities for improvement
- Other duties as required to support the Pharma manufacturing site operations
Who You Are
You are a passionate scientist, engineer or investigation writer who strives for continuous improvement within the pharmaceutical manufacturing environment. Your collaborative nature allows you to effectively lead or support cross-functional teams, and you thrive in roles where you can shape and define the responsibilities.
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 Drug Substance, Drug Product, Oral Solid Dose or Oligonucleotide synthesis manufacturing operations
- Deviation and Investigation authoring
- Knowledge of global GMP regulatory requirements for biologics manufacturing
- Experience interfacing with inspectors/regulators
- Strong analytical skills with excellent written and oral communication skills
- Risk Management
Preferred Skills
- Experience with microbiological risk assessments, viral cross contamination risk assessments, pFMEA/FMEAs
- Strong understanding of Annex 1 and implementation
- Proven track record of successful execution in a fast-paced environment, collaborating across corporate and site functions and with 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.