Job Description

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:Manufacturing Specialist, Sterile Drug Product

LocationCruiserath, Dublin

BMS Cruiserath Biologics isseekingto recruita SeniorManufacturing Support Specialist to support the start-up ofourcommercial drug product manufacturing facility for itsbiologicscommercial portfolio and clinical pipeline. 

Reporting to theSenior ManagerofOperations,theSeniorManufacturing Support Specialistwill play a key role in theestablishingourmulti-productcommercialDrug Product Facility with both vial and syringe fill finishtechnology This shall be achievedby providing technicalleadership andinput into all phases of the project, suchas,CQV, Site Operational Readiness, Technical Transfer, new productintroductionand commercialization activities.Thesuccessful candidate shallwork to implement RFT culturewith SDP during start-up.

Post start-up thisrole will be embedded within theManufacturing Supportteamcharged withsupporting the Operational teamse.g.,provide leadership in OE principles,leadcomplexinvestigations,supportbatchdispositionandsupport new product introductions

The start-up nature of this project will require adaptability& innovationdue to the multiple project phases and multiple products onsite. The role will be both challenging& rewardingand will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS.

Key Responsibilities During Start Up

• SeniorManufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping,AVIand Primary Packaging

• Work with the project design, CQV,& theAutomation/CSVteamstofacilitatethe implementation of the project design and validation of the project for Drug Product Operations.

• Lead/support CQV,TechnicalTransferandOperational Readiness activities including but not limited to:

• New Product Introduction

• SOP Development and Implementation

• Training Material development

• MES / MBR Design

• CQV support,asrequired

• Prepare documentation (SOPs, MBRs, Logbooks)requiredto enable manufacturing start-upand complete training on time.

• Develop and execute training programs in support of multiproduct manufacturing.

• Supportestablishment ofOperational Excellence initiativese.g.,5S / Std Work / LSW / Kaizen / Problem Solving etc.

• Support development ofthe operational controls prescribed in the Contamination Control Strategy for Sterile Drug Product

• Mentorand develop members ofmanufacturingsupport team

Key Responsibilities Post Project Delivery

• Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping,AVIand Primary Packaging

• Provide SME input into cross-functional teams investigating& optimizingmanufacturing processes,procedures,anddocumentation.

• Lead operational related investigations and be the key point of contact for all othertechnicalinvestigations.

• Write process impact assessments to supportinvestigationclosure. 

• Own & drive change controls, CAPA’s, investigations, improvementprojectsand operational safety. Minimize human error and work with operations to remove sources of error.

• Work with Drug Product Associates to generate procedures and training documentation required to enable manufacturing start-upand complete training on time.

• Lead/support delivery of training to SDP team within area of responsibility

• SME in supporting businesssystemsi.e.,SAP.TrackWise,Maximoetc.

• Drives and supportscultureof continuous improvement initiatives and safe working practices.

• Lead/support external and internalaudits.

• Lead/support the disposition process.

• Lead/support introduction of new products to manufacturing

• Lead and implementnew technologysolutions

• Lead/support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

• Designeefor Sr. Manufacturing Manager, whenrequired

Qualifications & Experience

A Bachelors in a science, engineering, or related subject

• The successful candidate mustpossessa Bachelor/Masters in Engineering, or Science related subject.

• 5+ years’ biologics manufacturing experience.

• Experience in start-up desirable

• Experience in new product introduction / technical transferdesirable

• Expertisein sterile drug product manufacturing along withdemonstratedproficiencyin technical troubleshooting and resolution isessential

• Ability to support the close out of complex technical investigations.

• Strong working knowledge of systems such asTrackWise, SAP

• Experience inparticipatingin regulatory inspections such asHPRA,FDA.

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-site gym

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602496 : Senior Specialist, Manufacturing Support