Job Description

Job Description

The individual is responsible for leading the Analytical Development Protein Chemistry group within the Biochemistry and Chemistry Development (BioCD) group that develops all analytical methods supporting the protein pipeline (R2D through commercialization), many of which are used by Biogen Quality Control laboratory to release commercial and clinical materials. The individual is an effective cross-functional leader and collaborator that builds strong relationships within the BioCD leadership team, the Protein Bioassay team group, the Protein Development group in PTD, the greater AD organization as well as the Quality organization. The role can be located in RTP or in our Cambidge location.

The individual enables innovation in analytical testing and control strategy development with an eye towards platforms and automation that can enable all of Biogens portfolio, as well as strong expertise in protein structural characterization and comparability strategies. The individual aligns resources and budgets, develops a vision, sets directions and facilitates a positive and flexible work culture. In addition, the individual will establish relationships within PTD, and with R&D, Manufacturing Sciences, Manufacturing, and Regulatory.

Responsibilities include:

* Manage day-to-day operations of the AD protein chemistry group. Align project requirements with demands of the portfolio for GMP and development support.
* Develops & implements manufacturing control strategies with special emphasis on advancing innovation in analytical controls. Enables quality control of manufacturing processes and release of materials.
* Develop roadmap and vision for the AD department supporting protein development and associated hiring, capital decisions and fee & services plans.
* Establish Biogen as recognized leader in protein development and influence regulatory landscape in relevant areas.
* Fosters a culture of innovation, efficiency, and can-do attitude to produce novel approaches; Identifies opportunities and collaborations to drive innovation and build internal capabilities. Develops talent.
* Facilitates technical interactions with our internal and external partners (e.g. Eurofins Lancaster, PPDi, Catalent, KBI, etc.) to support the development of our portfolio.

Qualifications

* Experience in supporting protein-based drug development programs (DS and DP).
* Experience in managing analytical activities for development (non-GMP) and GMP purposes.
* A history of supporting successful regulatory interactions (IND, IMPD, BLA) across clinical and commercial programs is essential. Experience with phase-appropriate comparability and impurity control strategies is also necessary.
* Demonstrated scientific expertise in protein characterization and structure-activity relationship to enable thorough product understanding and establishment of rational control strategy. Strong knowledge base in glycobiology is also required.
* Experience in managing large-sized teams of scientists and technical leaders.
* Demonstrated external influence in our industry.
* Strong communication skills and a demonstrated ability to clearly communicate complex issues to a non-expert audience.
* Strong people leadership skills and an interest in developing leaders.
* Experience in managing partners / CMOs collaborations.

Education:

PhD in Analytical Chemistry or Biochemistry with 12-15 years of related experience or MS Degree with 15+ years of related experience; Fundamental training in GMP and quality control in pharmaceutical manufacturing

Additional Information

The individual is responsible for leading the Analytical Development Protein Chemistry group within the Biochemistry and Chemistry Development (BioCD) group that develops all analytical methods supporting the protein pipeline (R2D through commercialization), many of which are used by Biogen Quality Control laboratory to release commercial and clinical materials.