Stability Enrollment, Trending, and Documentation Scientist

Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsStability Enrollment, Trending, and Documentation ScientistHyderabad - TS - IN No longer accepting applications.Job IDR1602031Date posted05/04/2026DepartmentNot ApplicableKey ResponsibilitiesThis position is responsible for facilitating the initiation of commercial stability studies, tracking the enrollment of stability batches, assembling, analyzing and reporting of stability data. The responsibilities include authoring stability initiation documents and other related documents including the Master Stability Protocols, Study Specific Protocols, CMO Stability protocols and Batch enrollment forms.Responsible for creation and tracking of the stability annual requirements, and year end requirement checkResponsible for batch identification as per annual program Responsible for LIMS study creation and data management. Responsible for stability data entry, reporting and trending into reports (e.g. Annual Product Quality Reports, Annual Reports, Annual Product Stability Reviews, and other reports).  Assembles, reviews and trends stability data from either internal or external sources using statistical packages (e.g. JMP).Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products’ performance/stability profileAuthors stability sections of CTD (Common Technical Document) dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability-related responses to health authority inquiries.Supports activities involving Change Controls and CAPA’s Follows department stability procedures and ensures consistency with site department and BMS proceduresSupports health-authority inspection internal and external.Owns departmental deviations within the scope of stability enrollment operationsEnsures training requirements are met. Effectively manage projects, escalate issues as necessary and identify/meet key milestonesTeam leadership skills that contribute to meeting team goals and resolving complex issuesExercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policiesQualifications & ExperienceEducation:Minimum of a Bachelor’s degree5+ years experience in the BioPharma/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT)Strong working knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility  Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.  Ability to work collaboratively in a team matrix environment is required.  Ability to identify, manage, and/or escalate issues and risks to timelines.Significant...