Senior Scientist, MS&T API

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. Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of contract manufacturing organisations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network. This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS External Manufacturing is looking to recruit on a fixed term (temporary) contract a Senior Scientist, MS&T API to join our Pharma Manufacturing Science and Technology group. The role is based in Dublin (Ireland) and will report to Senior Principal Scientist/Associate Director, MS&T API. The Pharma Manufacturing Science and Technology group is responsible for the provision of technical expertise in the areas of API and Drug Product manufacture in an external manufacturing environment. Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs The Senior Scientist, MS&T API role requires demonstrated experience of the technical management of processes relating to the manufacture of small molecule API. Key Duties and Responsibilities: Provision of ongoing technical support and oversight for a portfolio of externally manufactured APIs, Intermediates and Starting Materials, ensuring consistent security of supply. Leading technology transfers to contract manufacturing organisations. Technical oversight and direction for process validation. Assessing manufacturing requirements and capabilities prior to the transfer of a new process into manufacturing facilities and providing floor support during the validation campaigns, as well as review of process data to ensure operational consistency. Supporting CMO/vendor selection – preparation of technical information packages, participating in technical due diligence and site assessments, technical evaluation of RFIs and RFPs. Preparation, distribution and presentation of project status reports to project team members and management. Ensuring robust process performance at our CMOs post the transfer. Providing technical leadership for process monitoring, control and continuous improvement strategy and management. Identifying and executing process robustness improvement projects, where required. Using this information and knowledge to contribute to comprehensive and accurate annual product and annual contractor reviews Providing technical leadership in the understanding of root causes for out-of-trend or out-of-specification results or deviations for API or intermediate manufacturing processes. Providing technical leadership for change management, investigation CAPA identification and related activities at CMO site. Driving the use of strategies, resources and processes (OPEX) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale. Providing manufacturing descriptions and technical evaluations for regulatory filings and provides technical support to address Health Authority questions and inspections. Qualifications, Knowledge and Skills Required: A graduate or post-graduate level qualification in chemistry, chemical engineering or related field. Ideally a Ph.D. qualification in Chemistry, preferably synthetic organic chemistry. Relevant industrial experience (ideally > 5 years) is essential. Subject Matter Expert in relevant API chemistry, process development, process management and troubleshooting, process robustness improvement In-depth knowledge of pharmaceutical process scale-up, tech transfer and manufacturing support (change control, investigations, process optimisation). Understanding of process, engineering, analytical and regulatory aspects (cGMP, ICH, filing, EHS). Demonstrated project management and technical leadership capability. Demonstrated capability to lead complex technical investigations and in the use of standard tools for root cause analysis. Thorough understanding of statistical process analysis and control methods. Experience in using Statistical software packages. Confident management of internal and external stakeholder relationships. Ability to build effective working relationships throughout the organisation. Experience in collaborating with CMOs. The position will require varying levels of travel - ability to travel up to 20%. 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, 23.5 days annual leave plus 3 Company days, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus. 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 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. 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.