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 V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e., SAP. Trackwise, Maximo etc.).
Co-ordinating delivery review of batch and exception reports for manufacturing lots in conjunction with Quality Assurance representative for area of responsibility
Drives and supports culture of continuous improvement initiatives and safe working practices.
Designee for Tech Lead, when required.
Support any other business deliverables as needed.
Qualifications & Experience
A Bachelors in a science, engineering, or related subject is desirable
Minimum 3 years' experience in a GMP environment with a minimum of 1 years' biopharma manufacturing experience
Expertise in sterile drug product manufacturing along with demonstrated proficiency in technical troubleshooting and resolution is highly desirable.
Ability to flexibly adapt to changing business needs in a start-up environment.
Experience in lean manufacturing techniques and tools advantageous
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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-s
Benefits
Performance bonus
Additional Information
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 .
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 Sterile Drug Product Technical Lead will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. The SDP Technical Lead will provide technical input into 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
The position will commence on a day schedule, with a planned transition to shift work in the future
Bristol-myers Squibb · Cruiserath -, Ireland