Senior Specialist, Manufacturing Support

Job title:

Senior Specialist, Manufacturing Support

Company:

Bristol-Myers Squibb

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 rich in diversity. 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: .Bristol Myers Squibb IrelandBristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business unitsLocated in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022.Position SummaryBMS Cruiserath Biologics is seeking to recruit several Senior Manufacturing Support Specialists to support the start-up of our commercial drug product manufacturing facility for its biologics commercial portfolio and clinical pipeline.Reporting to the Senior Manager of Operations, the Manufacturing Support Specialist(s) will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. This shall be achieved by providing technical input into all phases of the 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 Manufacturing Support team charged with supporting the Operational teams e.g., lead investigations, batch disposition support and continuous improvement initiatives.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 During Start Up

• Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping and Visual Inspection
• Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
• Prepare documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.
• Support CQV, Technical Transfer & Operational Readiness activities including but not limited to:

• MFG Ops input into CQV, Operational Readiness and Tech transfer documentation
• Support the Ops teams with task-based risk assessment, SOP and OJT development
• Training Material development
• MES / MBR Design
• Material flow, consumable design, room programming
• CQV support including FAT attendance as required.
• Develop and execute training programs in support of multiproduct manufacturing.
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Key Responsibilities Post Project Delivery

• Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping and Visual Inspection
• Provide SME input into cross-functional teams investigating & optimizing manufacturing processes, procedures, and documentation.
• Lead operational related investigations and be the key point of contact for all other technical investigations.
• Own & drive change controls, CAPA’s, investigations, improvement projects and 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-up and complete training on time.
• Support delivery of training to SDP team within area of responsibility
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Support external and internal audits.
• Support the disposition process.
• Support introduction of new products to manufacturing
• Designee for Sr. Manufacturing Manager, when required.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & Experience

• A Bachelors in a science, engineering, or related subject
• The successful candidate must possess a Bachelor/Masters in Engineering, or Science related subject.
• 2 – 3+ years’ biologics manufacturing experience.
• Expertise in sterile drug product manufacturing along with demonstrated proficiency in technical troubleshooting and resolution is highly desirable.
• Ability to support the close out of complex technical investigations.
• Strong working knowledge of systems such as TrackWise, SAP.

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-HybridIf 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 an inclusive culture, promoting diversity 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 ProtocolBMS has a diverse 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.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 . Visit to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.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:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Expected salary

Location

Ireland

Job date

Thu, 06 Feb 2025 04:46:06 GMT

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