**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 rich in diversity. 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. Read more: careers.bms.com/working-with-us . Our Chemical Process Development group is a team of organic chemists, analytical chemists, and chemical engineers working together to design novel syntheses from raw materials to supply new medicines to patients. Our scientists focus on developing safe, economical, sustainable, and robust processes to support clinical trials and the launch of new medicines across various drug modalities including small molecules, peptides, oligonucleotides, and antibody drug conjugates. The work is driven by innovative science, data-driven decision-making, and collaborative teamwork. The scientific knowledge package from the manufacturing process, design parameters, and control strategies enables regulatory filings to bring these novel medicines to patients worldwide. **Position Summary** This position provides comprehensive cGMP services to Chemical Process Development including performing comprehensive deviation investigations including accurate root cause analysis for internal events and managing external deviation events with CDMO partners, BSE/TSE risk assessment process owner/subject-matter expertise (SME), Quality Risk Management (QRM) facilitator, and leading Data Integrity Risk Assessments (DIRAs). **Key Responsibilities** + Maintain and update records for all investigations within the electronic Quality Management System (eQMS). + Perform comprehensive quality investigations including accurate root cause analysis and ensure timely completion of investigations. + Ensure appropriate CAPAs are designed and implemented in compliance with cGMPs and other relevant regulatory requirements. + Provide administrative support for Kilo-Lab and vendor batch record documentation workflows. + Lead the BSE/TSE risk assessment process for clinical actives & intermediates. Primary SME for the Global Data Repository (GDR) system and issuing PD TSE Statements for intermediate/API release files. + Serve as a Quality Risk Management (QRM) facilitator for living (periodic review) and new risk assessments which support the clinical API supply chain. + Lead Data Integrity Risk Assessment (DIRA) workflows for both equipment/systems/instruments and processes. + Assist in the continuous maintenance of the Quality Management System (QMS) to ensure the Kilo-Lab is in a state of audit readiness. + Provide audit back-room support for the Kilo-Lab, including searching/reviewing/compiling all supporting documentation prior to and during the audit process. + Maintain relevant Change Management records in the eQMS. + Provide surge support for procedural document periodic review workflows, maintenance of CPD job descriptions and role-based training curricula. + *Not all inclusive; other responsibilities may be added. **Qualifications & Experience** + Bachelors degree in scientific discipline (pharmaceuticals, chemistry, engineering, etc.) with 5-7 years of experience or Masters degree with 2-4 years of experience or PhD with 0-2 years of experience + Experience supporting GMP Operations in the pharmaceutical industry. + Proven track record of managing root cause analysis quality investigations / event management. + Experience assessing pharmaceutical products for TSE risk in compliance with EMA/410/01 rev. 3.0, supporting QA release statements. + Experience with Quality Risk Management (QRM) tools, including Data Integrity Risk Assessments. + Experience with Veeva eQMS and eDMS platforms as well as SAP/SuccessFactors Learning Management Systems (LMS). + Proficient with SAP ERP systems and Microsoft Office applications. + Ability to multi-task and collaborate cross-functionally. + Clear communication skills, ability to prioritize work, and manage projects to completion independently. 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 an inclusive culture, promoting diversity 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 a diverse 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. 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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. 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/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1589592 **Updated:** 2025-02-23 04:48:37.332 UTC **Location:** New Brunswick-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.