Scientist II, Analytical Development- Oligonucleotides
4 weeks ago
Biogen is seeking a qualified and motivated candidate to fill a Scientist II position within its Oligonucleotides Analytical Development organization. This individual will work with other scientists to develop state-of-the-art analytical methods for the release and characterization of oligonucleotide-based products in the Biogen portfolio from pre-clinical through commercialization. This position is ideally suited for someone with a background and broad knowledge in oligonucleotide therapeutics and the methods used to analyze them. Particularly, prior experience with liquid chromatography and mass spectrometry are preferred.
The successful candidate will design, execute, and document analytical method development and qualification experiments, work with other team members and the team manager to devise phase-appropriate analytical control strategies for the different oligonucleotide products, and collaborate with key stakeholders from different parts of the technical CMC organization including process development, manufacturing sciences, quality control, regulatory CMC, and asset leaders.
This is an on-site role based at our Headquarters in Cambridge, MA.
Responsibilities include (but are not limited to):
Develop, optimize, and qualify LC-MS based method for the characterization of oligonucleotide products.
With the help of peers and the manager, design experiments, execute them, analyze the data, and author reports.
Maintain analytical instruments, troubleshoot them, and coordinate their preventative maintenance or service request with the appropriate teams.
Practice tidiness and cleanliness in the laboratories and don personal protective equipment to ensure a safe and compliant working environment.
Develop control strategies and propose specifications for drug substances and drug products.
Actively engage with CMC teams as the analytical development program representative (ADPR) to advance the Biogen oligonucleotides programs. 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 analytical control strategies, and method transfer to QC and external partners.
Author relevant sections of regulatory filing documents and formulate responses to the regulators’ questions.
Champion and lead innovation in new technologies, data analysis, and machine learning applicable to analytical development.
Demonstrate impact through scientific presentations at internal (group meetings and townhalls) and external (conferences) meetings. Get involved in industry-wide consortia and working groups to shape the future of oligonucleotide therapeutics development.
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