Stability Enrollment, Trending, and Documentation Scientist-4 Full-time NEW

Stability Enrollment, Trending, and Documentation Scientist

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).
• 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 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.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ “, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602028 : Stability Enrollment, Trending, and Documentation Scientist-4