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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 seeks to employ a permanent QC Materials Senior Manager, Contract Laboratory Management and ICT to lead the CTL and ICT teams. Reporting to the Associate Director for QC Materials Management, this role will be responsible for ensuring compliance with regulatory and health and safety requirements, implementing and maintaining robust test methods, ensuring that contract laboratory testing and ICT testing are completed to schedule, and delivering continuous improvement initiatives in the ICT laboratory.

Key Responsibilities

• Responsible for the establishment of the QC ICT Laboratory as part of the introduction of Sterile Drug Product operations.

• Management of the operation of the Incoming Components Testing L aboratory, ensuring all incoming components used in SDP manufacturing are tested and released in a compliant manner according to agreed business turn around times .

• Overall responsibility for the management of the incoming components sampling plans in Cruiserath .

• Maintain a high standard of GMP compliance in the laboratory.

• Ensure the laboratory is operated in a safe manner and a Safety culture is embedded within the team.

• Responsible for the m anagement of all commercial testing out sourced to Contract Test Laboratories .

• Responsible for the successful method technical transfer of ICT, both on site and in the Contract test Laboratories.

• Liaise with site teams to s upport all technical transfer activities in the Contract Test Laboratories .

• Responsible for building and maintaining strong relationships with the Contract T est Laboratories through hosting regular business review meetings and implementing the supplier scorecard initiative .

• Liaise closely with the Procurement and Supply Chain team s for the management of the Contract Test Laboratory budget and costs to ensure accurate forecasting and capacity planning .

• Responsible for the management of method, specification and compendial updates .

• Liaise with the QA Compliance team to ensure Quality Agreements with the Contract Test Laboratories are in place and support auditing of the same as required .

• Coordinate and manage audit readiness, both internal and external (e.g., HPRA/ FDA), taking ownership of topics as appropriate during regulatory inspections .

• Ensure investigations and deviations are completed in a timely and compliant manner and robust CAPAs are implemented , both internally and in the Contract Test Laboratories .

• Deliver a Strategic Workforce Plan for the Contract Test Laboratories management and QC ICT tea ms, encompass ing SDP targets , commercial and NPI BOW and future DS technical transfers .

• Provide first hand leadership and communication of business-critical information to the team through the tier board management system.

• Leads the drive for digital solutions and optimisations in the QC Laboratories through supporting the department in the delivery of the digital tiered management structure and digital QC strategy milestones, including lean labs.

• Represent the overall QC Materials pillar at network meetings as required .

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

• Leads and fosters an environment of continuous improvement e.g. standard work

• Supports the continuous development of all team members in line with the QC progression model , completing performance appraisals and providing feedback to the QC teams .

Qualifications,"Knowledge and Skills Required:

• The successful candidate must possess a Bachelor/ Masters in Science or Science related discipline and have a minimum of 10 years' experience in the Pharmaceutical Industry.

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

• Experience with the direct management of Contract Test Laboratories .

• Experience with the management of a testing laboratory is desirable.

• Working k nowledge of QC systems LIMS is desirable.

• An accomplished people manager 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 management skills to manage a team of professionals through changing business needs.

• Experience with method transfers and compendial verifications is preferable, as well as experience interacting with regulatory agencies.

• Knowledge of compendia, US and EMA GMP regulations and guidance.

• Demonstrated management, interpersonal, communication, and motivation skills.

• Demonstrated understanding of test methods and instrumentation associated with the testing of drug substance and drug product 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 be change agile and will have proven decision-making ability.

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

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

BMS 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 adastaffingsupport@bms.com . Visit careers.bms.com/ 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: R1582932

Updated: 2024-06-30 03:46:45.282 UTC

Location: Cruiserath-IE

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.