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Scientist II, Small Molecule Formulation Development
4 months ago
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 role based 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
- Ph.D. in Pharmaceutical Science, Materials Science, Chemical or Mechanical Engineering, or related field with 2 - 5 years of relevant industry experience
- Good knowledge of small molecule formulation techniques and concepts of drug product process development
- Experience/knowledge in formulation development for a range of dosage forms including solids and liquids from early to late phase.
- Strong problem-solving and troubleshooting skills, strong capabilities in experimental design and execution, as well ability to work independently are essential.
- 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.
- Proven skills and ability to work collaboratively with both internal and external partners.
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
