Manager, Technical Lead, Sterile Drug Product (Manufacturing)

Bristol Myers Squibb; Fingal; On-site; EUR 100,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Job summary

Bristol Myers Squibb’s Cruiserath Sterile Drug Product team is seeking an experienced SDP Technical Lead to guide on-floor manufacturing and deliver high-quality fill-finish operations.

You will oversee CQV, transfer, readiness, and validation activities, lead technical issue resolution, and drive continuous improvement with Lean tools.

Qualifications

• 5 years' experience in a GMP environment including at least 2 years SDP manufacturing
• Bachelor’s degree in Science or Engineering or related discipline
• Strong knowledge of SDP manufacturing operations: formulation, filling, capping, lyophilisation, inspection
• Experience in start-up or scale-up environments and problem-solving capabilities

Responsibilities

• Provide on-floor technical leadership to SDP manufacturing teams
• Lead troubleshooting during start-up and facility qualification/validation
• Collaborate with cross-functional teams on design, transfer, and readiness activities
• Support commissioning, qualification, validation and tech transfer
• Drive continuous improvement and 5S / standard work initiatives

Skills

GMP experience

Sterile Drug Product manufacturing

Technical leadership

Problem solving

Lean manufacturing

Education

Bachelor’s degree in science or engineering

Tools

DeltaV

Syncade

OSI/Pi Historian

SAP

TrackWise

Maximo

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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 position will commence on a day schedule, with a planned transition to shift work in the future

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 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 Bachelor’s degree in Science, Engineering, or a related discipline is desirable.
• 5 years’ experience in a GMP environment, including at least 2 years of Sterile Drug Product (SDP) manufacturing
• Strong understanding of Sterile Drug Product (SDP) manufacturing operations, including formulation, filling, capping, lyophilisation, visual inspection, and equipment preparation, is highly desirable.
• Experience working in a sterile manufacturing facility and demonstrated technical troubleshooting and problem-solving capabilities are preferred.
• Ability to adapt flexibly to changing business needs in a start-up environment.
• Experience with lean manufacturing techniques and tools is advantageous.

Why you should apply

• You will help patients in their fight against serious diseases
• You willbe part ofa 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-site gym

#LI-Onsite

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606276 : Manager, Technical Lead, Sterile Drug Product (Manufacturing)