Sterile Drug Product Manufacturing Lead – Startup & Ops
Bristol-Myers Squibb
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Benefits offered by this job
Job summary
Bristol Myers Squibb is recruiting a Manager, Manufacturing Support, Sterile Drug Product at the Cruiserath facility to help start up and scale our commercial SDP operations. You will lead technical transfer, CQV and readiness activities across vial and syringe fill-finish processes, while mentoring a growing team.
The role requires 5+ years in biologics manufacturing, experience with sterile DP, and familiarity with TrackWise and SAP.
Qualifications
- Bachelor’s or Master’s degree in engineering or science.
- Expertise in sterile drug product manufacturing with troubleshooting Skills.
- Experience in starting up biologics manufacturing facilities is desirable.
- Experience with regulatory inspections (HPRA, FDA) is advantageous.
- Ability to lead cross-functional teams and drive technical investigations.
Responsibilities
- During Start Up: provide SME input for Formulation, Filling, Lyophilization, Capping and Visual Inspection; support CQV, Tech Transfer and Operational Readiness; develop training materials; support risk assessments and SOPs.
- Post Project Delivery: own change controls, CAPAs and investigations; drive continuous improvement and safety; support audits and qualification activities; enable new product introductions.
Skills
Education
Tools
Job description
Bristol Myers Squibb is recruiting a Manager, Manufacturing Support, Sterile Drug Product at the Cruiserath facility to help start up and scale our commercial SDP operations. You will lead technical transfer, CQV and readiness activities across vial and syringe fill-finish processes, while mentoring a growing team.
The role requires 5+ years in biologics manufacturing, experience with sterile DP, and familiarity with TrackWise and SAP.
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