Scientist I / Sr. Engineer I, MFG Sciences

Job Description

About This Role  

The Scientist I/Sr Engineer I will contribute as a scientific resource for purification in Mfg Sciences on drug substances manufactured at Biogen’s RTP facility. They will provide technical expertise on chromatography and filtration steps of protein therapeutics, either developing and performing laboratory experiments towards process optimization and robustness or leading tech transfer activities for downstream GMP operations.

What You’ll Do  

• Provides in-depth technical expertise for biologics purification including harvest, column chromatography, and filtration (UF/DF, TFF, viral) in support of technology transfer of drug substance products to manufacturing, as well as process improvement activities.  
• Leads cross-functional project teams, collaborates with technical development, and supports engineering and GMP batch production.  
• Supports investigations as the technical SME as needed. Represents the technical manufacturing process perspective on items such as change control, continuous improvement, capital projects, and new component introduction. Prevents process deviation recurrences through implementation of proper corrective measures. 
• Supports the development of SOPs, batch records, and training modules for new or modified purification processes. Authors technical documents, provides data and reports to support process robustness/understanding, investigations, and regulatory submissions as needed.
• Supports Process Validation batch production activities and assures smooth transition of process to commercial operations. Develops technical conclusion reports summarizing process validation activities.  
• Perform laboratory experiments towards process optimization or robustness.
• Effectively and efficiently communicate results and decisions to the Process Technologies team (and to external groups when appropriate, e.g., technology transfer team, site management, and technical development).
• Author technical, developmental, and validation reports. Provide data and reports to support process robustness/understanding, investigations, and regulatory submissions as needed

Who You Are  

You are a highly motivated and creative individual with applicable knowledge in mammalian cell-based drug substance manufacture. You are passionate for exploring novel science-based strategies and excited for hands-on work to define the cutting-edge technologies used at Biogen.

Qualifications

Required Skills  

• • Degree in Chemical Engineering or a related discipline.
  • Bachelors Degree with a minimum of 5 years applicable experience OR Masters Degree with a minimum of 3 years OR PhD with a minimum of 1 year of experience
  • Technical knowledge of biopharmaceutical manufacturing and/or process development.
  • Excellent communication skills; ease and comfort in interacting with various teams in identifying solutions to support manufacturing activities.

Preferred Skills 

• Standard information technology skills are expected

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.