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Senior Manager, Principal Scientist Packaging
Ireland , Dublin
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Posted: 2022-07-15
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Job Overview & Requirements
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. 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 manufacturing contract operations (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 We are seeking to recruit a Senior Manager, Principal Scientist Packaging, on a permanent basis, for our Manufacturing Science & Technology group based in Dublin Provide packaging technical support to External Manufacturing and Contract Manufacturing Organisations (CMOs) who manufacture and package BMS products. Ensure robust and compliant process performance at CMOs during commercial manufacture by use of continuous process verification and Operational Excellence. Ensure the transfer of robust packaging processes to CMOs. Support CMO selection process – compilation of technical packages, due diligence, generate scorecard ratings. Change management and technical assessments to support same. Provides technical support and leadership in serialisation activities at CMOs. Deviation Management, including leading technical investigations at CMOs. Accountable for site to site packaging technology transfer of products ensuring robust technical transfer within budget constraints. Generates, where required, reviews and approves site technology documents such as Technology Transfer plans, Validation Master plans, Process risk assessments etc. Support operational management of CMO as per Virtual Plant governance structure. 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. Represents Manufacturing Science & Technology on project teams and works closely with Supplier Relationship Management and project team members in developing strategies and problem-solving efforts. 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. Qualifications & Experience 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. Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposes. Experience with the technical transfer of products to CMOs. Ability to close-out investigations and deviations at CMOs. Excellent verbal, written communications and presentations skills, including influencing skills, excellence at writing complex study plans and scientific reports. Ability to work with minimal supervision, while keeping management and stakeholders appropriately informed. Knowledge of regulations concerning cGMP, manufacturing, packaging, validation, quality systems, equipment innovations, upgrades, and instrumentation. Proven record in pharmaceutical packaging technology, technology transfer and packaging/manufacturing support/activities A 3rd level degree in science or a related field At least 7 to 10 years relevant experience What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. 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 Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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.
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Job Summary
Category
Engineering
Country
Ireland
City
Dublin
Employment Type
Full Time
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