Senior Manager, Principal Scientist Packaging

<p><b>Working with Us</b><br/>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.</p><p></p><p>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: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank"><span><span><span><span><span><span>careers.bms.com/working-with-us</span></span></span></span></span></span></a>.</p><p></p><p></p><p><b>Bristol Myers Squibb Ireland</b></p><p></p><p>Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.</p><p></p><p>Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.</p><p></p><p>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.</p><p></p><p>For more information about Bristol Myers Squibb, visit us at BMS.com/ie</p><p></p><p></p><p><b>The Role</b></p><p></p><p>BMS External Manufacturing is looking to recruit on a<span>  </span>Fixed Term Contract (2,5 years), <span>Senior Manager, Principal Scientist Packaging</span>, for our Manufacturing Science &amp; Technology group based in Dublin, reporting to Director, Packaging and Artwork OUS.</p><p></p><p>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.</p><p></p><p></p><p><b>Key Duties and Responsibilities:</b></p><ul><li>Provide packaging technical support to External Manufacturing and Contract Manufacturing Organisations (CMOs) who manufacture and package BMS products.</li><li>Ensure robust and compliant process performance at CMOs during commercial manufacture by use of continuous process verification and Operational Excellence.</li><li>Ensure the transfer of robust packaging processes to CMOs</li><li>Support CMO selection process – compilation of technical packages, due diligence, generate scorecard ratings.</li><li>Change management and technical assessments to support same.</li><li>Provides technical support and leadership in serialisation activities at CMOs.</li><li>Deviation Management, including leading technical investigations at CMOs.</li></ul><ul><li>Accountable for site to site packaging technology transfer of products ensuring robust technical transfer within budget <span>constraints.  </span> Generates, where required, reviews and approves site technology documents such as Technology Transfer plans, Validation Master plans, Process risk assessments etc.</li><li>Support operational management of CMO as per Virtual Plant governance structure.</li><li>Provide ongoing technical support to ExM / CMO to ensure compliance and security of supply – metrics review, investigation close-out, change control review, APQR review, process improvement. Implement Operational Excellence initiatives as necessary.</li><li>Represents Manufacturing Science &amp; Technology on project teams and works closely with Supplier Relationship Management and project team members in developing strategies and problem-solving efforts.</li><li>Product robustness - technical lead for creation of packaging process robustness monitoring plan, process control strategy, and provides technical oversight of CMO sites to ensure continuous process monitoring for all products in scope.</li></ul><p></p><p></p><p><b>Qualifications, Knowledge and Skills Required:</b></p><ul><li>In-depth knowledge of primary and secondary packaging of Oral Solid Dosage, Devices or Parenteral products with knowledge of global regulatory requirements related to design and control of these processes. </li><li>Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposes.</li><li>Experience wit