Stability Enrollment, Trending, and Documentation Scientist-3 Full-time

Stability Enrollment, Trending, and Documentation Scientist-3

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Key Responsibilities:

• Facilitating the initiation of commercial stability studies, tracking the enrollment of stability batches, assembling, analyzing and reporting of stability data.
• Authoring stability initiation documents and other related documents including the Master Stability Protocols, Study Specific Protocols, CMO Stability protocols and Batch enrollment forms.
• Creation and tracking of the stability annual requirements, and year end requirement check
• Batch identification as per annual program
• LIMS study creation and data management.
• Stability data entry, reporting and trending into reports (e.g. Annual Product Quality Reports, Annual Reports, Annual Product Stability Reviews, and other reports).
• Assemblies, 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 profile
• Authors 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 procedures
• Supports health-authority inspection internal and external.
• Owns departmental deviations within the scope of stability enrollment operations
• Ensures training requirements are met.
• Effectively manage projects, escalate issues as necessary and identify/meet key milestones
• Team leadership skills that contribute to meeting team goals and resolving complex issues
• Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies

Qualifications & Experience:

Education:

• Minimum of a Bachelor's degree
• 5+ 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 experience with evaluating and interpreting stability data using statistical software.

Very good understanding of pharmaceutical regulatory requirements  

Very good understanding of regulatory and stability guidelines, storage requirements and cGMP 

Working knowledge of LIMS software, and trending / statistical software. 

Working knowledge of drug substance and drug product manufacturing and good understanding of analytical and microbiological methods.

Works independently, review data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects and deliver according to overall strategy.

Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc.

Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.