Senior Drug Product Associate, Sterile Drug Product

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.

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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.  

Position Summary

BMS Cruiserath Sterile Drug Product is seeking an experienced individual with aseptic manufacturing experience to provide on the floor technical leadership to our manufacturing teams within our new Sterile Drug Product (SDP) facility.

Reporting to the Senior Manager, Manufacturing Shift Lead, the Senior Drug Product Associate will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. The Senior Drug Product Associate will provide input and support all phases of the SDP project, such as, CQV, Site Operational Readiness, Technical Transfer, new product introduction and commercialization activities.  Post start-up this role will be embedded within the shift teams charged with delivering the manufacturing plan for the facility.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS.

This position will be initially on days but will move through various shift patterns as the project progresses to full commercial manufacture

Key Responsibilities

• Manufacturing SME in one or more processes that include Formulation, Filling (vial & syringe), Lyophilization, Capping, Visual Inspection & Primary Packaging
• Lead technical issue troubleshooting, resolution both during and post facility start-up.
• Work with the cross functional departments to facilitate the implementation of the project design and validation of the SDP manufacturing facility.
• Support all phases of Commissioning / Qualification and Validation during Start-up phase of state-of-the-art Drug Product Facility
• Support all Capital / Tech Transfer / Operational Readiness activities including but not limited to:
  • Vendor site Factory Acceptance Tests
  • MES / MBR Design
  • SOP Development and Implementation
  • Training Material development
  • Room layouts and Ways of Working
• Support delivery of training to SDP team on day-to-day operations within area of responsibility
• Work in conjunction with the Shift Lead/Technical Lead to build the SDP Manufacturing teams technical competencies across a given area.
• Lead the Right First-Time execution of commercial manufacturing processes within areas of responsibility.
• Support key meetings on behalf of Manufacturing.
• Support and Lead key Operational Excellence initiatives (5S / Std Work / LSW / Kaizen / Problem Solving etc.)
• Support Operational related investigations and bey the key point of contact for all other functional investigations
• SME in use of process automation systems (i.e., Delta