Senior Specialist, QA Drug Substance Disposition

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.

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 Specialist, QA Drug Substance Disposition for a 12 month fixed-term contract. Reporting to the Senior Manager, QA Manufacturing Operations, the Senior Specialist, QA Drug Substance Disposition will support the execution and maintenance of the QA activities related to Manufacturing operations and site operations on days in Cruiserath.

Key Responsibilities

• QA support of manufacturing operations (commercial operations and new product introductions)
• Support the Disposition process for Drug Substance
• Preparation of Batches for QP release
• QA Operations review of events and investigations
• Authoring, review and approval of QA-related procedures
• Review and approval of functional area documentation
• QA support for implementation of Manufacturing Execution System (MES) and development of batch records
• QA support of the BMS Enterprise Resource Planning System (SAP) including data verification and integration testing for the Quality function
• Change control assessment and CAPA evaluation/CAPA close-out
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support OpEx programs and champion continuous quality improvement initiatives.
• Participate in the product recall and health authority notification process in accordance with BMS procedure.
• Engage in Quality Culture initiatives

Qualifications & Experience

• BSc in Science or related discipline with a minimum of 2 years’ QA Operations or related experience in a Biologics or Pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Detailed knowledge of Biologics Processing would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team.
• Must be able to work across a team matrix in order to meet accelerated timelines
• Excellent communication and presentation skills are essential
• Excellent time management and organisational skills along with a proven ability to multi-task
• Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.

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 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.

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.

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/

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