Sr. Scientist, Small Molecule Formulation Development

4 weeks ago


Cambridge Massachusetts, United States Biogen Full time
Job Description

Biogen is seeking a qualified candidate to fill a Scientist II or Senior Scientist position within its Small Molecule Development organization. This individual will work with other scientists to develop drug product formulations including pediatric formulations to support small molecule formulation development from pre-clinical through commercialization. This position is ideally suited for someone with a background and broad knowledge in solutions and suspensions and other formulation platforms suitable for pediatrics, knowledge in the characterization of such formulations and the ability to use material-sparing tools to create robust manufacturing process.

The successful candidate will design, execute, and document formulation and process development studies for all kinds of drug candidates especially for those that are poorly soluble and be able to present technical information at appropriate level to stakeholders.

This is an on-site position at our headquarters in Cambridge, MA. 

Responsibilities include (but are not limited to):

Develop both oral liquid and solid dosage forms for clinical use and commercialization.

Help develop strategy and formulation development plans for pediatric formulations.

Actively engage CMC teams as the Formulation lead and contribute to deliverables and participate in cross-functional technical review and troubleshooting.

Propose, and advocate for project timelines; be the primary point of contact for technology transfer to inform planning, communication; inform and/or influence the selection of external partners and external innovation.

Execute and oversee technical transfers, scale up and clinical manufacture at internal drug-product GMP facilities and at CMOs.

Apply materials science principles and techniques to develop, characterize, and implement processes and next generation technologies to solve technical challenges and clearly communicate the value of the scientific initiative.

Champion and lead innovation in process modeling, data analysis and machine learning applicable to drug product development.

Provide support, as needed, to clinical drug product manufacturing through process capability analysis and product impact/risk assessments for process changes/improvements and non-conformance investigations.

Author/review guideline documents, technical protocols, reports, product impact and risk assessments, and drug product sections in IND, IMPD and NDA filings



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