- Act as the subject matter expert (SME) in biophysical assay development. Responsible for leading analytical and biophysical method development, qualification, characterization, and transfer for proteins and ATMP programs. Review biophysical and particle analysis data generated both internally and externally at Contract Research Organizations (CROs).
- Evaluate new analytical capabilities (instrumentation, methods, software) for biophysical characterization and particle analysis. Lead internal and external collaborations and drive innovations. Publish in peer-reviewed journals, and present at scientific meetings.
- Lead biologics/ATMP programs as an AD program representative in a cross-functional program team. Oversee analytical strategy and method development, coordinate analytical development activities and participate in decision-making for programs. Support process development and regulatory filings by authoring protocols, reports, and CMC regulatory sections.
- Lead the biophysical/higher-order-structure and particulate matter analytical capabilities in matrix teams and mentor junior scientists. Represent AD in cross-functional/cross-industry forums; identify potential gaps and solution strategies in department business practices.
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- Direct working experience in the biophysical field, with subject matter expertise in biophysics related to proteins and large molecule therapeutics such as AAVs.
- Knowledge and expertise in different biophysical assays, including Analytical Ultracentrifugation (AUC), particle analysis methods (HIAC/MFI), Circular Dichroism (CD), Fourier-transform Infrared (FTIR), fluorescence, mass photometry, dynamic light scattering (DLS), Differential scanning calorimetry or fluorimetry (DSC/DSF), etc.
- Knowledge or experience in protein higher-order structure characterization with mass spectrometry-based methods such a hydrogen/deuterium exchange, covalent labeling, or foot printing methods is highly desirable but not required.
- Working experience with other separation methods, such as CE-SDS, icIEF, liquid chromatography is desirable.
- Ability to perform advanced data analysis of biophysical data using different software; experience with basic coding is desirable.
- Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, ability to work on multiple projects simultaneously, as well as ability to work independently and collaborate cross-functionally.
- Good understanding of GxPs, ICH guidelines, analytical method qualification and technology transfer.
- 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.
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Senior Scientist, Technical Development - Cambridge, United States - Biogen
Description
Job Description
Job DescriptionJob DescriptionAbout This Role
Biogen is searching for a biophysicist to fill a Senior Scientist position within the Analytical Development (AD) – Biologics/Advanced Therapies & Medicinal Products (ATMP) department in Cambridge, MA. This key technical leadership role will lead the biophysical and higher-order-structure characterization for biologics and advanced therapies including monoclonal antibodies, antibody conjugates, bispecific antibodies, therapeutic proteins, and AAV-based gene therapy. He/she will work collaboratively in a cross-functional team on a range of innovative pipeline programs and develop state-of-art methods and technologies to support process development and regulatory filings. The successful candidate will bring expertise in the field of biophysical technologies, higher-order structure characterization (e.g., analytical ultracentrifugation (AUC), spectroscopy), and particle analysis techniques (light obscuration and flow imaging) to solve complex analytical challenges. The individual is also expected to lead in a matrix team to develop analytical strategies and characterization plans, drive decision-making, and support regulatory filings.
This is an on-site role to be based at our Headquarters in Cambridge, MA.
What You'll Do
Who You Are
You will work cross-functionally in a matrixed environment and can work independently and creatively to influence stakeholders across the development organization. You should have excellent technical skills, the ability to think outside the box, and the ability to drive experiments from proof of concept to implementation. You should be able to clearly communicate your results and accomplishments to a broad audience at team meetings and in written reports. You should have self-motivation and drive to make impactful contributions in a fast-paced environment.
Required Skills
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.
