Principal Scientist, Analytical Method Sciences F

Bristol-Myers Squibb

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.

Job Summary

The Principal Scientist within the Analytical Method Sciences Team at Bristol-Myers Squibb (BMS) will play a critical role in method lifecycle and providing technical Quality Control (QC) support. This individual serve as a key technical expert to ensure the robustness and reliability of analytical methods for large molecule assets. The Principal Scientist will work closely with global QC labs to troubleshoot assays, support method-related investigations, and provide day-to-day execution and method training. This position requires a strong foundation in bioanalytical methods, a quality mindset, and the ability to drive continuous improvement in method performance.

Location: Cruiserath / Devens

Key Responsibilities:

• Provide on-site technical support to global QC labs, ensuring the robustness and reliability of bioanalytical methods.
• Troubleshoot and resolve assay issues, partnering with QC labs to conduct method-related investigations.
• Ensure operational aspects of methods are clearly captured and robust, facilitating seamless method execution.
• Method Training and Execution
• Deliver comprehensive method training to QC lab personnel, ensuring consistent execution across global testing networks.
• Embed within labs as needed to support day-to-day method execution and troubleshooting.
• Lead the provision of hands-on technical support for commercial biologics methods, ensuring adherence to global standards.
• Participate in audits and Health Authority inspections, providing SME support and assisting in the generation of HA responses and CAPAs.
• Contribute to the development of regulatory strategies for biologics methods control, including specifications and reference standards.
• Author and review regulatory submissions from licensure throughout the product lifecycle, ensuring compliance with global regulatory requirements.
• Utilize lean tools to improve method execution and performance, driving enhancements in efficiency and reliability.
• Collaborate with GQCAS teams and Site QC to identify and implement improvements in method performance, aiming for Right First Time testing and higher productivity.
• Mentor and coach junior scientists, fostering a high-performance culture within the QC organization.
• Partner with stakeholders from Analytical Strategy & Lifecycle, MS&T, Manufacturing, GRS and Operations to develop effective strategies and ensure alignment with organizational goals.

Qualifications & Experience:

• In depth knowledge of common analytical techniques used in the bio-pharmaceutical industry such as iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS etc., including method qualification/validation, method development and/or method transfer
• Proven track record in Quality Control (QC) within the biopharmaceutical industry, particularly in a GMP-regulated environment.
• Demonstrated successful leadership of cross-functional teams, stakeholder management, and ability to ensure progress of complex projects under defined timelines
• Demonstrated ability to troubleshoot complex separations and bioanalytical assays and provide technical support to QC laboratories.
• Extensive experience in managing complex method-related investigations and resolving technical issues.
• Demonstrates ability to analyze and interpret data to draw appropriate conclusions, identify problems/gaps, and recommend potential next steps or solutions to ensure good scientific, compliance and regulatory outcomes.
• Experience supporting audits and Health Authority inspections, including providing SME support and generating HA responses and CAPAs.
• Experience in developing and executing quality control strategies, ensuring compliance with global regulatory standards.
• Significant industry experience in independently writing formal reports/documents and preparing technical presentations
• In depth knowledge of FDA and international regulatory guidelines and standards as well as extensive experience with supporting Health Authority inspections
• Strong understanding of global regulatory requirements and experience authoring and reviewing regulatory submissions.

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 assurance, 27 day annual leave, life assurance and on-site gym

BMSBL

#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

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.