About This Role:
At Biogen, we are advancing science to deliver innovative therapies that transform patients’ lives. We are seeking a Scientist II to join our Analytical Development team as a Liquid Chromatography (LC) Subject Matter Expert (SME) and Analytical Project Lead. This role is pivotal,leveragingdeep technicalexpertisein LC method development alongside leadership in analytical strategy across synthetics programs. Situated in Cambridge, MA, this lab-based position plays a crucial part in driving forward the development of synthetic drug substances and products, ensuring robust, stability-indicating methods. Your contributions will be vital to our mission, interfacing with variousteamsand shaping the analytical landscape of our drug development efforts.
What You’llDo:
- Serve as the LC subject matter expert, leading method development, optimization, qualification, and troubleshooting (HPLC, UHPLC, LC-MS).
- Develop robust, stability-indicating methods for synthetic drug substances and products.
- Provide technical support to inform analyticalstrategyfor development programs from early to late stage.
- Collaborate cross-functionallywith CMC, formulation, process development, and quality teams.
- Provide oversight of analytical activities at CDMOs, including method validation, transfer, and lifecycle management aligned with regulatory expectations.
- Participate in mentoring and knowledge-sharing activities to support analytical capability building within the organization.
- Contribute to programs involving emerging modalities (e.g., oligonucleotides and peptides).
Who You Are:
You are enthusiastic about tackling complex analytical challenges to advance the development of small molecule therapeutics and oligonucleotides. You are motivated to learn new techniques and become a subject matter expert. You thrive both independently and collaboratively within a team setting, bringing a passion for scientific innovation and a commitment to excellence.
Required Skills:
- Ph.D. with 0-3 years of relevantexperiencein pharmaceuticalor biotech settings
- M.S. with 4+ years of relevant experience in pharmaceutical or biotech settings.
- BS with 6+ years of relevant experience in pharmaceutical or biotechsettings
- Deepexpertisein small molecule LC method development, with strong experience in HPLC/UHPLC and familiarity with LC-MS.
- Proven ability to lead analytical activities for drug development programs.
- Strong knowledge of ICH guidelines and experience working within regulated (GMP/GLP) environments.
- Excellent problem-solving, communication, and cross-functional collaboration skills.
Preferred Skills:
- Experience with oligonucleotides and/or peptides.
- Advanced MS techniques (e.g., LC-MS/MS, HRMS).
Job Level: Management