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Senior Manager, Principal Scientist Packaging

4 months ago

Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

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 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.

The Role

BMS External Manufacturing is looking to recruit on aFixed Term Contract (2,5 years), Senior Manager, Principal Scientist Packaging, for our Manufacturing Science & Technology group based in Dublin, reporting to Director, Packaging and Artwork OUS.

Key Duties and Responsibilities:

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, Knowledge and Skills Required:

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 5 to 10 years relevant experience

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.

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