Senior Specialist, Manufacturing Projects Support Scientist - Engineer
Bristol Myers SquibbAbout the role
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. 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, 2021 and 2022.
The Role
The Manufacturing Projects Support Scientist role is a key contributor and part of the BMS team for sustainable biologics manufacturing capacity and new product introductions to the BMS network.
Key Duties and Responsibilities:
- Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes at BMS
- Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing
- Support product change over protocols to allow a smooth transition from sustaining to new product manufacturing
- Represent the Manufacturing at meeting to ensure the end user requirements are represented
- Supports process technology transfer, and the preparation of manufacturing documentation for development, engineering and PPQ batches.
- Identify process improvement projects for New Product Introduction and support projects to completion.
- Work with sustaining team to understanding current issues and ensure impact of new products are defined, agreed and understood
- Write process impact assessments to support new product introduction
- Provide SME input into cross-functional teams investigating & optimizing new manufacturing processes, procedures and documentation.
- Provide training to BPAs on new procedures.
- Support external and internal audits.
- Work with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction .
- Work to implement a “Right-First Time Culture” and provide leadership in the use of OE principles.
- Support the disposition process when required
- Carry out organizational activities such as purchasing & co-coordinating communication information.
- Own & drive change controls, CAPA’s, investigations, improvement projects and operational safety.
- Minimize human error and work with operations to remove sources of error.
- Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team.
- Support sustaining operations when required to ensure product supply
- Develop strong working relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, Finance.
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