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Manager, Senior Manufacturing Specialist
Manager, Senior Manufacturing Specialist-September 2024
Cruiserath
Sep 21, 2024
ABOUT BRISTOL MYERS SQUIBB
Bristol Myers Squibb is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
10,000+ employees
Biotechnology, Healthcare
VIEW COMPANY PROFILE >>
About Manager, Senior Manufacturing Specialist

  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: careers.bms.com/working-with-us .

  Bristol Myers Squibb Ireland

  Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

  Located 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 Summary

  BMS Cruiserath Biologics is seeking to recruit a Senior Manufacturing Support Specialist 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 Senior Manufacturing Support Specialist 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 leadership and input into all phases of the project, such as, CQV, Site Operational Readiness, Technical Transfer, new product introduction and commercialization activities. The successful candidate shall work to implement RFT culture with SDP during start-up.

  Post start-up this role will be embedded within the Manufacturing Support team charged with supporting the Operational teams e.g., provide leadership in OE principles, lead complex investigations, support batch disposition and support new product introductions.

  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

  Senior 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.

  Lead/support CQV, Technical Transfer and 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.

  Development of planning and scheduling tools to support the project and future state routine operations.

  Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

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

  Mentor and develop members of manufacturing support team.

  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.

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

  Drives and supports culture of continuous improvement initiatives and safe working practices.

  Lead/support external and internal audits.

  Lead/support the disposition process.

  Lead/support introduction of new products and/or technologies to manufacturing.

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

  Qualifications & Experience

  The successful candidate must possess a Bachelor/Masters in Engineering, or Science related subject.

  5+ years’ biologics manufacturing experience.

  Experience in start-up desirable

  Experience in new product introduction / technical transfer desirable

  Expertise in sterile drug product manufacturing along with demonstrated proficiency in technical troubleshooting and resolution is essential.

  Ability to support the close out of complex technical investigations.

  Strong working knowledge of systems such as TrackWise, SAP.

  Experience in participating in regulatory inspections such as HPRA, 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 annual leave, life assurance, on-site gym and gain-sharing bonus.

  #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 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 Protocol

  Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

  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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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.

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

  Company: Bristol Myers Squibb

  Req Number: R1577801

  Updated: 2024-01-22 09:05:27.705 UTC

  Location: Cruiserath,Ireland

  Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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