About This Role:
Biogen is seeking a dedicated and skilled Senior Scientist to become an integral part of our Small Molecule Analytical Development team. As a Senior Scientist, you will take on the pivotal role of supporting our small molecule drug candidates' analytical method development and qualification. You will represent the analytical department in cross-functional teams, contributing significantly to the progression of pharmaceutical products through the development pipeline. This role requires you to collaborate with both internal colleagues and external experts to address intricate analytical challenges. Your input will be crucial in ensuring that our analytical methods adhere to the highest quality, regulatory, and technical standards. Within the company's structure, you will be at the forefront of innovation, with your work contributing directly to Biogen's commitment to excellence and our ability to deliver breakthrough therapies.This is a lab-based role onsite at our Headquarters in Cambridge, MA.  What You’ll Do:Develop and qualify analytical methods for small molecule drug candidates, aligning with stringent quality and regulatory standards.Serve as the analytical representative within cross-functional teams, supporting drug development from early-stage research to late-stage clinical trials.Provide mentorship to junior scientists and guide them through complex analytical processes.Play a key role in preparing technical reports, regulatory submissions, and other documentation integral to regulatory filings.Conduct routine and advanced analyses of drug substances and products using techniques such as HPLC, GC, spectroscopy, mass spectrometry, and dissolution testing.Analyze and interpret experimental data, ensuring results are well-documented in adherence to good documentation practices (GDP).Troubleshoot analytical issues, offering innovative solutions for method development and validation challenges.Who You Are:
You are a scientist with a passion for analytical chemistry and a desire to further pharmaceutical advancements. You thrive in a collaborative team environment, yet you're self-motivated and capable of independent work. With a robust foundation in analytical techniques and regulatory standards, you are ready to tackle complex challenges and drive projects to completion. You have a mentor's spirit, eager to share knowledge and guide those around you. Precision and attention to detail are in your professional DNA, and you communicate scientific data with clarity and impact. You are the Senior Scientist we seek—ready to contribute your expertise to a dynamic team at Biogen.Required Skills:Ph.D. in analytical chemistry, pharmaceutical sciences, or a related field with 4-6 years of post-degree experience.Profound knowledge and hands-on experience with various analytical techniques for small molecule analysis, including but not limited to LC, GC, dissolution, MS, NMR, and spectroscopy.Familiarity with chemometrics and process analytical technology (PAT) is highly desirable.Understanding of current regulatory guidelines pertinent to small molecule analytical development (e.g., ICH, FDA, EMA).Proven track record with method validation and stability studies.Exceptional problem-solving and troubleshooting abilities, with strong skills in experimental design and execution.Outstanding written and verbal communication skills, adept at presenting data in a clear and succinct manner.A collaborative spirit, able to work effectively within multidisciplinary teams.Meticulous attention to detail, particularly in experimental planning, data analysis, and documentation processes.
- ID: #53655274
- State: Massachusetts Cambridge 02138 Cambridge USA
- City: Cambridge
- Salary: USD TBD TBD
- Job type: Full-time
- Showed: 2025-03-17
- Deadline: 2025-05-16
- Category: Et cetera