Job Description

Responsible for contributing to key functional, tactical, and operational aspects of the Global Stability group at Biogen. Serve as a subject matter expert in multiple disciplines, interfacing with key customers.  provides technical support during audits/inspections. This requires excellent written and verbal communication skills.  Previous experience managing small molecule and/or oligonucleotides stability programs is preferred.

• Design and manage studies.  Independently author stability protocols and collaborate with Sample Control and QC laboratories 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 department in internal and external audits proficiently.
• Contribute to major/critical manufacturing and lead stability investigations (deviations, OOS, cross-site and cross-functional). 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 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

Qualifications

• Advanced knowledge of operations/quality systems/directives and ability to 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.
• Provide leadership and problem solving skills for complex situations/issues to effectively reach solution.
• Mature leadership approach and understanding of personal communication style.
• Accountable for measurable goals/targets in work area.
• Possess strong organizational skills with ability to multi-task and coordinate multiple activities in parallel.
• Good knowledge of FDA/EMA regulations and compliance.
• Formulate solutions/options for 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.
• Education: BA/BS in Life Sciences with 5+ years of relevant industry experience.

Additional Information

The Sr Associate I, QC 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.