Senior Principal Scientist, Analytical Governance and Scientific Operations

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: .

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

Reporting to the Director of Analytical Governance and Scientific Operations (AGSO), the AGSO Senior Principal Scientist plays a pivotal role in supporting project management of all commercial method transfers and validations of biologics methods, in directing project Governance across the Biologics Analytical Method & Strategy (BAMS) team projects and in management of analytical changes across the network. This role demands an individual with expertise in biologics analytical methodology, and a strong track record of technical leadership in the biopharmaceutical industry. The role will direct the running of Governance frameworks for commercial Biologics Analytical programs and projects in addition to the analytical Book of Work for both commercial QC and BAMS teams. This includes Governance frameworks for all analytical method transfers, validations, regulatory filling, health authority queries, analytical change controls and QMS Laboratory Controls procedural documents. The AGSO team is responsible for coordinating and translating the business asks for QC testing (from MS&T, EXM, BAMS) into demand forecasts, budget asks and prioritization discussions. The role will inform and support the running of a project governance framework, to enable QC prioritization and strategy discussions with analytical leadership, Manufacturing Science &Technology, Regulatory, CMC, QC, Quality and the Bio Operations Unit. The role will involve management of commercial method transfers and validations of biologics methods to internal and in-market locations, partnering with Biologics Development to ensure on time and right-first-time transfers and validations to meet business demands and support requirements.

Key ResponsibilitiesAs a senior member of the AGSO team, partners across GQCO&AS, global quality, product development and the manufacturing sciences and technology organization to facilitate the governance structures and processes for advancement of projects from process validation to licensure, and maintenance of products throughout the commercial lifecycle.Provides guidance, coaching and direction to AGSO scientists in the planning and execution of analytical method validation and technical transfer activities within commercial Bio-Sterile QC labs, (in partnership with wider GQCO&AS, Site Quality and MS&T Brand teams) including protocol and report generation and project management and schedule adherence.Plays a strategic role in the running of the Biologics Commercial Analytical Governances, including BAMS Tier governance structure, BAMS Project portfolio, Commercial Analytical Portfolio framework.Manages the Global Biologics commercial QC Book of Work, for non-routine commercial testing requirements, partnering with the wider Biologics QC Operations leadership team to ensure the QC labs plan appropriately to meet business needs.Plays a strategic role in the running of knowledge management processes and systems for all BAMS teams, including SharePoint, BAMS team training curricula, work request process.Facilitates the implementation of a quality risk management (QRM) program to mitigate risk in conjunction with BMS Manufacturing/Supply management and Quality.Plays a strategic role in the running of the Laboratory Controls Level 2 in our Quality Management System, and related support to all BMS GMP and GCP laboratories.Lead efforts to scope, plan, and implement process improvements including accountability for sustainable improvements, such as process, procedure, systems, and training material changes and use of appropriate change management and communication principles.Support audits and Health Authority (HA) inspections across GPS as it relates to Lab Controls QMS, analytical method tech transfer and analytical method validation, including the assistance in the generation of HA responses and CAPAs. Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines.Exemplifies the core BMS values of Passion, Innovation, Urgency, Accountability, Integrity, and Inclusion.Embodies a compliance, quality, and continuous improvement mindset.Develops and coaches team members to enhance their skillsets and enable efficiency within operations.Leads with a global mind-set to direct and influence multiple remote teams.Executing for Results: Maintain high standards of performance, consistently collaborates with all stakeholders, and follows through on commitments. Makes decisions with an enterprise mindset and when faced with challenging obstacles, exemplifies always doing what is in the best interest of patients.Conveys a sense of urgency and drives issues to closure. Makes timely decisions when a quick response is required and ensures evaluation of several options when needed.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.Mentor and develop junior members of the ASL team, promoting a culture of continuous learning and improvement.Qualifications & Experience Advanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) preferredProficiency in Quality Control and Analytical processes and regulations, e.g., cGMP/GDP regulationsA thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of analytical technical transfers and validationThorough understanding of technical areas related to chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.10 years of experience in Quality and Compliance organizations.Experience managing analytical project activities is essential.Knowledge of FDA and international regulatory guidelines and standards as well as experience with supporting Health Authority inspectionsExcellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.Demonstrated ability to drive performance and achieve operational goals.Uses judgment to make sound decisions based on information gathered and analyzed.Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.Sets and maintains high performance standards. Pays close attention to detail, accuracy, and completeness.Adapts to changing work environments, work priorities and organizational needs.Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.Enterprise advocate: appropriately evaluates tradeoffs to make decisions that are in the best interest of BMS and of our patients; understanding the bigger picture beyond own functional area, seeks to have an impact on organization wide performance; embrace complexity but strive for simplicity.External mastery: constantly looks outside the organization to understand customer needs, competitors and global trends and uses the data to achieve a competitive advantage for BMS. Why you should apply You will help patients in their fight against serious diseasesYou will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employeesYou'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 gymBMSBL

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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 . Visit 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.

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