Small molecule analytical program management and leadership in analytical method development in support of novel drug product formulations. Hands on experience and intellectual knowledge of technologies such as UHPLC, HRMS, spectroscopy, dissolution, and API characterization techniques will be used to elucidate and solve formulation, synthesis and drug delivery challenges. Cross-functional interactions and the ability to work innovatively and independently to influence other stakeholders across the development organization is a key responsibility of this position.

Responsibilities

• Represent analytical function on cross-functional and project teams
• Lead analytical development activities to support small molecule drug substance and drug product development in support of IND and NDA filings
• Engage with regulatory authorities through IND/NDA filings and agency meetings
• Develop phase appropriate control strategies to support the pipeline, identify bottlenecks in the analytical processes, and lead cross-functional efforts to implement improvements
• Provides technical leadership to project teams within area of expertise
• Contributes significantly and independently to project work which includes multiple projects within functional area
• Reviews, interprets and communicates data cross-functionally within CMC and project teams
• Plans and implements resolutions to technical problems/issues
• Interface directly with counterparts at CMOs and oversees analytical technology transfer
• Identifies industry trends and provides guidance on how to maintain operational excellence
• Write, review, and edit technical documents and SOPs
• Transfer analytical methodology to quality control and contract laboratories
• Supervise/mentor junior scientists
• Contribute to industry white papers, publish in peer reviewed journals, present at or chair sessions at major conferences

• Proven scientific leader with the ability to influence others
• Demonstrated ability to manage the development and qualification of analytical methodologies for the characterization and understanding of small molecule products (both API and DP) and processes. Experience in supporting the development of enabling formulations and lyo/parental formulations.
• Applied knowledge of GMP and applicable FDA, EMA and ICH guidance documents and familiarity with the USP and other compendia are expected.
• Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, as well ability to work independently are essential.
• Strong technical writer, reviewer, and communicator
• Able to expresses one’s self clearly and concisely within team
• Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
• Proven skills and ability to work collaboratively

• Ph.D. in analytical chemistry, pharmaceutical science, or related discipline with a minimum of 14 years of experience in the industry

Biogen is seeking a qualified candidate to fill a Principal Scientist/Associate Director position within its Analytical Development organization. This role will be responsible for method development, characterization and control strategies of small molecule drug candidates from pre-clinical through commercialization. The successful candidate will work in a highly collaborative environment to utilize their skills in partnership with internal and external experts to solve complex analytical challenges. This individual will lead cross-functional project teams collaborating with colleagues in Chemistry, Formulation, Drug Discovery, Drug Delivery, Toxicology, Quality and Regulatory groups. The ideal candidate will develop and implement forward thinking analytical solutions to streamline activities in a phase appropriate manner to support a growing portfolio.