Manager, Technical Lead, Sterile Drug Product

Bristol Myers Squibb; Fingal; On-site; EUR 90,000 - 130,000; Full time

Job summary

Bristol Myers Squibb is seeking an experienced Sterile Drug Product Technical Lead to provide floor-level technical leadership for the SDP facility in Dublin. You will guide CQV, transfer, and commercialization activities, transitioning as start-up evolves into steady-state manufacturing.

The role requires adaptability across multiple project phases and products, with future shift work. This is a leadership position offering challenging, rewarding opportunities within a cutting-edge sterile

Qualifications

• Bachelor's degree in science, engineering or related field is desirable.
• Minimum 3 years’ GMP experience with biopharma manufacturing exposure.
• Expertise in sterile drug product manufacturing with strong technical troubleshooting.

Responsibilities

• Serve as Manufacturing SME for Formulation, Filling, Lyophilization, Capping, Visual Inspection & Primary Packaging.
• Lead technical issue troubleshooting during start-up and post-start-up.
• Collaborate with cross-functional teams to validate SDP facility and implement project design.
• Support commissioning/qualification/validation during start-up phases of the facility.
• Coordinate Capital/Tech Transfer/Operational Readiness activities and QA reviews.
• Coordinate vendor FATs and MES/MBR design activities.
• Develop SOPs and training materials; design room layouts and work practices.
• Train SDP team on day-to-day operations and build technical competencies.
• Lead Right First Time execution of manufacturing processes; support operational excellence initiatives.

Skills

GMP experience

Biopharma manufacturing

Sterile drug product manufacturing

Technical troubleshooting

Lean manufacturing

Education

Bachelor's degree in science/engineering

Tools

DeltaV

Syncade Interactions

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 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

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.

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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 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

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