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 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

　　Cruiserath Biologics is seeking a permanent Associate Director of Quality Control (QC) Materials to manage and continuously develop the Sample Management, Raw Materials, Incoming Components, CCIT, Contract Test Laboratory, Reference standard and Critical Reagent Teams in support of the site Drug Substance & Sterile Drug Product Manufacturing Operations. This position will provide Strategic Guidance & Oversight, technical and compliance support as a QC Leader to support QC site operations at BMS Cruiserath.

　　Reporting to the Quality Control Director, this position has responsibility for the Sample Management, Raw Materials, Incoming Components, CCIT, Contract Test Laboratory, Reference standard and Critical Reagent Teams. This position is responsible for the recruitment, development and management of the QC Materials organisation.

　　Key Responsibilities

　　Principle QC liaison with site manufacturing operations teams with respect to routine testing and support for samples & materials.

　　Ability to build an expanded QC Materials operations team to support Site Sterile Drug Product start up activities, GMP operational readiness and Tech Transfer Program

　　Recruitment, development and management of the Material labs.

　　Budget management of capital and operational costs for the QC Materials teams.

　　Accountable for the sample management and processing of all Drug Substance, Drug Product and Raw Materials for the Site.

　　Responsible for the in-house routine testing & release of non-compendial raw materials and all incoming components.

　　Responsible for the completion of all Drug Product CCIT testing for the site.

　　Responsible for Reference Standard and Critical Reagent Management for the site.

　　Manage outsourced testing for the microbial and chemistry testing of raw materials, incoming components, Drug Substance and Drug Product for release based on specification. Manage out-sourced testing including contract lab qualification.

　　Support manufacturing process validation activities for Drug Substance operations including timely raw material release testing.

　　Quality oversight and leadership for complex deviations and significant events

　　Review and approve IND, BLA and other technical documents for regulatory agency submissions and author responses to agency questions as required.

　　Coordinates & directs audit readiness, both internal and external (HPRA/ FDA), including vendors and contract lab audits

　　Ensures the QC Shared Services Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations.

　　Builds and fosters strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives.

　　Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to QC

　　Responsible for coaching, developing staff and completion of performance appraisal reviews.

　　Support QC planning and scheduling activities as required.

　　Inspires transformative thinking and motivates employees to deliver benchmark performance.

　　Leads and fosters an environment of continuous improvement.

　　Prioritise safety in every aspect of the role

　　Lead by example in exemplifying safety behaviours

　　Qualifications & Experience

　　The successful candidate must possess a Bachelor/Masters in Science or Science related discipline. A minimum of 10 years’ experience in the Pharmaceutical Industry.

　　Deep and demonstrated understanding and experience of the principles of GMP / GDP

　　An accomplished team leader of large teams with the ability to motivate and develop departmental staff through effective feedback and coaching

　　The candidate will have proven success working well in a team environment, as well as proven leadership skills to manage a team of professionals through changing business needs.

　　Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture

　　Experience with technical transfer of new products and product changeover is essential, as well as experience interacting with regulatory agencies.

　　Must have extensive management experience of increasing responsibility.

　　Experience in building and growing an organization is desired

　　Extensive knowledge of US and EMA GMP regulations and guidance.

　　Demonstrated leadership, interpersonal, communication, and motivation skills.

　　Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including raw material release testing

　　Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.

　　The candidate will have demonstrated strong leadership and people / project management abilities, proven decision making ability and the ability to work well with and influence all levels of management and staff. Additionally, the successful candidate must be able to interact with a broad range of disciplines and exert positive influence within internal matrix teams across a variety of functions.

　　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: R1577846

　　Updated: 2024-01-23 11:04:22.555 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.