Summary

The main responsibility of this role is to align for Assets in E&T the development and CMC strategies within Pharmaceutical Development (Chemical Process Development, Pre-formulations, Formulations, Analytical) and integrate these strategies with the overall clinical development with Biogen Asset Teams.

Job Category: Technical Development
Requisition Number: 38228BR

Job Description:

The candidate will be a primary point of contact between Development and Asset Teams and foster communication across functions to technically align Development goals with Asset Team member functions. This will include defining development strategies through the pre-clinical and clinical phases, working with asset teams to integrate these strategies with operations groups through yearly budget management, managing resources shared with development of other Assets, and making clear development goals through short term 18 month and long term 5 year plans. Contributing to an integrated technical understanding for CMC strategy in other Biogen groups (QC, Stability, QA, Regulatory) is expected. Understanding of technical operations at contract sites and ensuring that different DS and DP sites are strategically aligned is necessary. It is expected the candidate will manage multiple early phase programs to ensure a common approach that expedites asset transition to IND filing with an emphasis on working with established partners to execute phase appropriate development strategies. Additional responsibilities will be to ensure a common level of phase appropriate development discussion in regulatory filings across programs, contribute to replies to regulatory agency questions, and to author phase appropriate development guidelines for current and future assets. The Scientist II/Senior Scientist candidate is expected to have experience with CMC operations within DS/DP/analytical development.

Main responsibilities:

• • Bring forward CMC strategies for pharmaceutical development to Biogen Asset Teams.
  • Resource planning, budget management, short term 18 month long term 5 year plans for individual assets.
  • Facilitate communication of program goals from asset team to Pharmaceutical Development. Engage PD subject matter experts to inform Asset team members on technical initiatives.
  • Lead continuous improvement initiatives to expedite phase appropriate development
  • Strategically align contract sites for development and delivery of clinical product.

Qualifications

• • Previous experience with asset team and cross functional management, Drug Substance and Drug Product process development, process transfers to GMP manufacturing, and working with Contract Manufacturing Organizations

Education

• • BS / BA (>7 years’ experience), MS or Ph.D. in Organic Chemistry (>3 years’ experience) preferred.

Employment Category: Full-Time Regular
Experience Level: Associate

Please submit resumes to: careersatbiogen@biogen.com