Technical Lead, Sterile Drug Product, Dublin

Job Title Technical Lead, Sterile Drug Product (R1602724)

Position Summary BMS Cruiserath Sterile Drug Product is seeking an experienced individual with aseptic manufacturing experience to provide on‑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 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.

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 and resolution both during and post facility start‑up.

Work with 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 the start‑up phase of the 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 be 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‑ordinate delivery review of batch and exception reports for manufacturing lots in conjunction with Quality Assurance representative for area of responsibility.

Drive and support culture of continuous improvement initiatives and safe working practices.

Designee for Tech Lead, when required.

Support any other business deliverables as needed.

Qualifications&Experience

Bachelor’s degree in a science, engineering, or related subject is desirable.

Minimum 3 years’ experience in a GMP environment with at least 1 year of 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 is advantageous.

Benefits

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‑site gym.

Equal Employment Opportunity BMS is an equal‑employment‐opportunity employer. We consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. BMS is dedicated to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request reasonable accommodations prior to accepting a job offer.

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