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
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
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,
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
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
Advanced knowledge of operations/quality systems/directives and
ability to apply the knowledge within the team/project management
Excellent technical writing, presentation and oral/written
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
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
Education: BA/BS in Life Sciences with 5+ years of relevant
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.