**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 . **Bristol Myers Squibb Ireland** Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie **The Role** BMS Cruiserath Biologics is seeking to recruit on a permanent contract Principal Scientist, Manufacturing Technology (Process Transfer and Validation). This **Principal Scientist** position is a subject matter expert in the technical transfer and process validation project portfolio delivering for all current and future drug substance processes at Bristol Myers Squibb, Cruiserath. Ensures processes are designed and validated per applicable current good manufacturing practices (cGMPs), site procedures, and that processes are defined consistent with regulatory filings. The role will also be responsible for key sections of Chemistry, Manufacturing, and Controls (CMC) submissions, along with setting relevant standards and procedures. This position will report into Associate Director, Manufacturing Technology (Process Transfer and Validation), Cruiserath Biologics. The successful candidate will act as matrix leader of cross functional technical teams delivering a wide portfolio of projects across the design, validation and post approval lifecycle of drug substance processes. **Key Duties and Responsibilities** + Accountable for technical leadership (Project Functional Lead) for Cruiserath site drug substance technical transfer projects and ExM drug substance technical transfer projects as appropriate. + Matrix technical leadership of FTE resources and direct contingent worker management as appropriate. + SME knowledge of the principles and concepts applicable to all aspects of commercial biologics drug substance manufacturing, process validation and regulatory submission. + Program owner (Cost, Yield, Robustness) with accountability for related portfolio of projects. + Accountable for delivery of MT-led MS&T / Cruiserath site PMO portfolio of projects (Brand, Facility, Equipment) + Accountable for technical leadership supporting MT resourcing across entire portfolio including non MT-led MS&T / Cruiserath site PMO portfolio of projects. + Accountability for authoring and/or technical review of relevant sections in readiness for CMC filing submission. + Accountable for technical aspects of site regulatory inspections with thorough understanding of regulatory environment, pre-approval inspections (PAI) supporting technical transfer and post approval process change. + Key contributor to the technical transfer business process across the Biologics drug substance network with responsibility for contribution to technical forums such as process validation excellence. + Routinely liaising within the MS&T internal BMS network for technical and operational improvements and issue resolution. + Seeks out opportunities to actively mentor within the organisation and establishes collaborative working relationships with other functional organisations and stakeholders. **Qualifications, Knowledge and Skills Required:** + Bachelor's degree or equivalent in relevant engineering or scientific discipline with extensive relevant experience across multiple roles. + Deep technical experience in all aspects of technology transfer of biologics drug substance processes including the establishment and validation of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities. Expert knowledge of global regulatory requirements related to the design and control of biologics drug substance processes. + Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control fundamentals in commercial manufacturing. + Thorough understanding of regulations, familiarity of regulatory environment and industry trends for Biologics Drug product. + Comprehensive experience as matrix lead for diverse teams and leading entire programs of complex technical projects across the design, validation and post approval lifecycle of drug substance processes. + Work strategically, excellent project management skills and the ability to successfully manage multiple programs and create a high-performance work environment. + Excellent communication and presentation skills and vast experience interfacing with multiple stakeholders and partner functions. **Why you should apply** + You will help patients in their fight against serious diseases + You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. + You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance. BMSBL **\#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** 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:** R1585695 **Updated:** 2024-09-24 04:46:05.515 UTC **Location:** Cruiserath-IE 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.