Scientist I, Quality Control at Biogen in Research Triangle Park, North Carolina

Posted in Information Technology 4 days ago.

Type: Full Time

Job Description:

Job DescriptionAs a Scientist I, you will work collaboratively with Quality Control, Analytical Development, Quality Assurance, Regulatory, internal / external manufacturing teams and other related stakeholders. You will represent the Analytical Technology group in CMC sub-teams as a subject matter expert responsible for leading method validation and tech transfer activities and addressing the questions from the regulatory agencies according to the program timelines. The ideal candidate is independent and self-driven with excellent project management and communication skills.Provide technical expertise on analytical methodologies for small molecule and/or ASO drug substance and drug products.Troubleshoot and lead complex analytical investigations.Evaluate, develop, validate and implement new technologies in a GMP, regulated environment.Author analytical method and validation section of regulatory filings and address the questions from the global regulatory agencies.Design analytical method transfer and validation studies, execute and coordinate execution within QC or contract laboratories.Author and review transfer and validation protocols/reports and perform statistical data analysis.Review and optimize analytical methods to make them robust and simple for GMP testing and ensure compliance with global regulatory agency guidelines.Being a technical steward working with contract laboratories across multiple regulatory markets.Manage projects across sites, companies and cross-functional areas; develop timelines and communicate priorities to leadership and stakeholders.Collaborate with QC and analytical development; communicate with stakeholders in manufacturing, manufacturing sciences, regulatory and QA.Author scientific publications and present at scientific conferencesCoach and mentor junior scientistsQualificationsMinimally PhD in Life Sciences with 0-1 year of experience, or MA/MS in Life Sciences with 4-6 years of relevant industry experience required.Expertise in small molecules or antisense oligonucleotidesSolid working experience with various analytical methods like UPLC, HPLC, dissolution, GC, mass spec and general compendia analysisSolid working knowledge of international regulatory guidelines, such as ICH, EP, JP, ChP. Experienced with global regulatory filings is plus.Statistical data analysis with JMP or other softwareCMC experience with managing cross-functional projects and project management tools for tracking and communicating progress is highly desired.Skilled in building good working relationships with stakeholders in manufacturing, QC and Analytical Development to effectively achieve the goals and objectives of Analytical Technology.Additional InformationBiogen is looking for an analytical scientist for the Analytical Technology (AT) department supporting Small Molecule (SM) and Antisense Oligonucleotide (ASO) programs. The AT team is focused on phase-appropriate analytical method validation, transfer, investigations, method optimization, new technology implementation and supporting global regulatory filings. We are currently looking for a scientist with extensive technical expertise in supporting SM and ASO projects.PDN-92c5bc40-7ef6-4c46-9cc3-0d603a3b2507