Scientist II, QC Analytical Technology

Job Description

Biogen is looking for an experienced analytical scientist for the Analytical Technology (AT) department supporting late stage Small Molecule (SM) development and commercialization programs. The AT team is focused on phase-appropriate analytical method validation, transfer, investigations, method optimization, new technology implementation and supporting global regulatory filings. We are currently looking for a scientist with extensive technical expertise in supporting our late stage small molecule commercialization projects.

As Scientist II, you will work collaboratively with Quality Control, Analytical Development, Quality Assurance, Regulatory, and external collaborating companies as well as contract manufacturing and testing organizations (CMO/CLO). You will represent the Analytical Technology group in CMC sub-teams as a subject matter expert responsible for leading method validation and tech transfer activities, analytical trouble-shooting, investigation and optimization at the external partner site, and addressing the questions from the regulatory agencies according to the program timelines. The ideal candidate is independent and self-driven with excellent project management and communication skills.

• Provide technical expertise on analytical methodologies for small molecule drug substance and drug products.
• Troubleshoot and lead complex analytical investigations.
• Evaluate, develop, validate and implement new technologies in a GMP, regulated environment.
• Author and review analytical method and validation section of regulatory filings and address the questions from the global regulatory agencies.
• Design analytical method transfer and validation studies, execute and coordinate execution within QC or in external contract laboratories.
• Author and review transfer and validation protocols/reports and perform statistical data analysis.
• Review and optimize analytical methods to make them robust and QC friendly for GMP testing and ensure compliance with global regulatory agency guidelines.
• Being a technical steward working with contract laboratories across multiple regulatory markets.
• Manage projects across sites, cross-functional areas and with collaborating companies; develop timelines and communicate priorities to leadership and stakeholders.
• Collaborate with QC and analytical development; communicate with stakeholders in manufacturing, manufacturing sciences, regulatory and QA.
• Author scientific publications and present at scientific conferences
• Coach and mentor junior scientists

Qualifications

Experience Scientist with the motivation and ambition to grow with a reputable organization.

• Minimally BA/BS in Chemistry or similar degree with 10 years of relevant experience from the biotech or pharmaceutical industry required.
• Extensive experience working in a GMP environment and late stage product development is preferable.
• Expertise in small molecule product development.
• Solid working experience with various analytical methods like UPLC, HPLC, dissolution, GC, mass spectrum, and general compendia analysis.
• Solid working knowledge of international regulatory guidelines, such as ICH, USP, EP, JP, ChP. Experienced with global regulatory filings is plus.
• Statistical data analysis with JMP or other software
• CMC experience with managing cross-functional projects and project management tools for tracking and communicating progress is highly desired.
• Skilled in building good working relationships with stakeholders in manufacturing, QC and Analytical Development to effectively achieve the goals and objectives of Analytical Technology.

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects usasa team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.