Scientist I, Global Stability Biologics & Gene Therapy
- Research Triangle Park, NC
The ideal candidate will be responsible for contributing to key functional, tactical, and operational aspects of the Global Stability Biologics & Gene Therapy group at Biogen.
This individual will provide technical expertise and leadership for the stability program of commercial/clinical products including design of stability protocols, maintaining data, expiry dating for products, authoring stability sections for submissions, technical assessment of stability specification changes, and stability investigations. They will also serve as a subject matter expert in multiple disciplines and interface with key customers.
Responsibilities of the position include:
- Design and manage studies. Independently author stability protocols and collaborate with Sample Control and QC laboratories as well as external CMOs/CLOs to ensure proper testing and reporting of stability samples. Manage moderately complex issues, barriers, problems to support team success.
- Possess thorough knowledge of methods for data trend analysis and stability data behavior. Perform technical review of complex analytical data, interpret data, and author in-depth technically-sound stability reports/regulatory submissions independently. Provide technical leadership through effective project management, status tracking, data analysis, presentations, and communication.
- Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the Global Stability organization. Actively provide leadership and mentoring as needed to aide in the development of team/peers, self, and team projects. Represent the department in internal and external audits proficiently. Author response to regulatory questions with minimal oversight.
- Contribute to major/critical manufacturing and lead stability investigations (deviations, OOS, cross-site, and cross-functional). Independently author stability assessments for Anomalous Results (ARs) and Out of Trend (OOT) stability results. Alert Quality organization about potential issues and evaluate remedial actions. Provide innovative solutions to unique complex problems. Proactively identify technical gaps and areas for improvement related to quality or process and lead them through completion.
- Participate on Asset sub-teams and maintain a thorough knowledge of CMC program for assigned products. Collaborate routinely with other line functions and sites as well as internal/external partners and lead cross-functional teams.
- Preferred experience with ATMP analytical technology and stability programs
- Advanced knowledge of operations/quality systems/directives and apply the knowledge within the team/project management routinely.
- Excellent technical writing, presentation, and oral/written communication skills.
- Author technically sound and highly complex reports and approve data/reports.
- Provide leadership for complex situations/issues problem solving to effectively reach a solution.
- Mature leadership approach and understanding of their personal communication style and manage that effectively.
- Accountable for measurable goals/targets in the work area.
- Possess strong organizational skills with the ability to multi-task and coordinate multiple activities in parallel.
- Good knowledge of FDA/EMA regulations and compliance.
- Formulate solutions/options for the team and reach out externally to regulatory/global teams for alignment.
- Conduct impact assessment related to compliance (e.g., global directives, audit finding/readiness, deviations).
- Leadership competencies include Personal Drive, Decision Making, Communication, Building Strategic Work Relationships, and Innovation.
BA/BS in Life Sciences with 10+ years of relevant industry experience, or MA/MS in Life Sciences with 7+ years of relevant industry experience, or Ph.D. in Life Sciences with 5+ years of relevant industry experience.
Are you a Scientist interested in an exciting career opportunity in Global Stability Biologics & Gene Therapy at Biogen? If so, we are seeking a strong leader for the stability program of commercial/clinical products including the design of stability protocols. If you believe your skills align, apply with us today.
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