Manager, Senior Process Engineer I - Viral Vector

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 Position Summary Global Manufacturing Science and Technology (GMSAT) is seeking a Senior Process Engineer I to join our viral vector team. The successful candidate will support efforts related to transfer commercial manufacturing technologies. This person will collaborate across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Senior Process Engineer I will play a key role in product tech transfer and lifecycle management. Key Responsibilities Support process and technology transfers, change management, and technical process support for vector products Act as a technical Subject Matter Expert (SME) within the MSAT group as well as for various project teams Support the authoring of regulatory filings across the product lifecycle Perform and support data monitoring of manufacturing processes to understand process capability, and trouble-shoot investigation-driven events Support continuous improvement initiatives to improve manufacturing success Provide technical oversight during technology transfer and manufacturing campaigns (e.g. process related technical trouble-shooting, deviation impact assessments/investigations, and change control assessment/implementation) Author and/or review manufacturing documentation as needed Collect, analyze, and present manufacturing data to internal stakeholders Qualifications & Experience Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects Demonstrated ability to perform/document complex manufacturing processes Experience providing technical support in either a clinical/commercial GMP environment Experience with cGMP, ICH guidelines, process validation, and control strategy development Experience working in a self-driven, performance/results oriented, fast paced matrix environment Familiar with six sigma principles a plus Verbal, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with cross-functional teams Excellent communication skills, both verbal and written, and the ability to interface effectively with cross functional teams Experience writing, and reviewing GMP documentation Able to creatively manage time and elevate relevant issues to project lead and line management Experience in providing technical assessments Experience with root-cause analysis tools Prior experience with SOPs, cGMPs and how they are applied within a regulatory environment required Prior experience participating in process characterization preferred Knowledge of cellular immunology and/or vector manufacturing a plus Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization Experience with disposable technologies such as flatware, SUBs and SUMs MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with 2 – 5 years of relevant experience in process development or commercial manufacturing Knowledge of lentiviral or adeno-associated virus manufacturing is a plus BMCART
LI-Hybrid 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.