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 Associate Director of Sterile Drug Product Technical Transfers (Manufacturing, Science & Technology) position. The person will be the principal subject matter expert and technical owner of the technical transfer project portfolio and subsequent routine production for all drug product processes manufactured in the new Sterile Drug Product Manufacturing Facility being built on the Cruiserath campus. This role 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 the Director or Senior Director within Biologics Manufacturing Science & Technology, Cruiserath Biologics. The successful candidate will lead a dynamic and highly technical team by setting appropriate objectives and priorities, overcoming obstacles; and timely delivering results. 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 Key Duties and Responsibilities: Accountable for the technical oversight of a portfolio of technology transfer biologics drug product projects for the Cruiserath Sterile Drug Product facility, including oversight of process design, validation and regulatory package authoring and successful inspection and approval. Highly advanced knowledge of the principles and concepts applicable to all aspects of biologics drug product manufacturing, equipment, materials and deviation / change management. Leading and mentoring a team of process SME’s for the technical transfer and subsequent routine production of multiple drug product processes at the Cruiserath Sterile Drug Product facility. This role will have several direct reports delivering the Technical Transfer for each product being transferred to site. Influences technical direction for biologics drug product manufacturing across Materials, Vial filling, Syringe Filling, Lyophilisation, Visual Inspection, Cleaning & Sterilisation. Accountable for technical aspects of site regulatory inspections with thorough understanding of regulatory environment and industry trends for biologics drug substance specifically in relation to Pre-Approval Inspections (PAI) supporting technical transfer and post approval process changes. Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control fundamentals in technical transfer and post approval process changes. Established as a mentor within the department and developing as a role model that influences culture and values across teams by actively promoting scientific and operational excellence. Routinely liaising within the MS&T internal BMS network for technical and operational improvements and issue resolution. Responsible for innovations that challenge the status quo. Leads highly visible, impactful and/or complex projects and continuous improvement initiatives. Drives effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Science, Technical Product Teams and others, both internally and externally to the site. Qualifications, Knowledge and Skills Required: The successful candidate must possess a Bachelor/Masters in Engineering, or Science related discipline with extensive relevant experience within Sterile Drug Product Manufacturing. Deep technical experience in all aspects of technology transfer of biologics drug product 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. Strong knowledge of global regulatory requirements related to the design and control of biologics drug product processes. Experience with Technical Transfer of new processes is essential, as well as experience interacting with regulatory agencies. An accomplished leader of technical teams with the ability to motivate and develop through effective feedback and coaching. Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture. Influence areas not under direct control to achieve objectives. Work strategically, excellent organisational skills and the ability to successfully manage multiple programs and create a high-performance work environment. Budget, plan and manage resources efficiently Strong strategic and analytical thinking, problem solving and rapid decision-making skills. Problem solving and project management ability, as well as lean manufacturing experience is essential. 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 an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus. 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. 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 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
[email protected]. Visit careers.bms.com/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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.