Job Description

Company Description Job Description The individual will develop and qualify analytical methods and characterize pharmaceutical drug candidates under development. The individual will also represent analytical function on cross-functional CMC teams for development strategy of pharmaceutical drug candidate. The candidate will be responsible for defining analytical control strategy for the program during early- and late-stage development, and author analytical-related regulatory filing. The work requires cross-functional interactions and the ability to work independently and creatively to influence stakeholders across the development organization. Excellent technical skills, the ability to think outside of the box, and the ability to drive experiments from proof of concept to implementation are required. The selected individual should be able to clearly communicate their results and accomplishments to a broad audience at team meetings and in written reports. Strong self-motivation and drive to make impactful contributions in a fast-paced environment is critical. The successful candidate is expected to play leading and supporting roles in different areas as needed, and to collaborate and matrix manage resources within the team in order to maximize efficiency and impact.

Qualifications

• Ph.D. in analytical chemistry, pharmaceutical sciences, or related discipline with a minimum 2-5 years of experience in the industry OR MS Degree with a minimum of 6-8 years of experience.
• In-depth knowledge and hands-on experience with different types of chromatography and dissolution technologies for small molecule DS and DP analysis.
• Demonstrated track record with supporting DP formulation development.
• Experience with analytical representation on project teams and driving the project forward.
• Knowledge in other characterization techniques such as MS, KF, Raman, IR, etc.
• Applied knowledge of GMP and applicable FDA, EMA and ICH guidance documents and familiarity with the USP and other compendia are expected.
• Ability to develop and qualify new analytical methods.
• Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, as well ability to work independently.
• Experience with IND/IMPD, NDA filing is a plus
• Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
• Strong verbal and written communication skills, strong interpersonal skills and the ability to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.

Additional Information Biogen is seeking a qualified candidate to fill a Scientist II position within its Analytical Development organization. This individual will be responsible for method development, characterization, and program representation to support the development of small molecule pharmaceuticals from pre-clinical development 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.