Scientist, Analytical Strategy & Lifecycle

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: ~~~/working-with-us .

Bristol Myers Squibb Ireland

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients' lives through science.

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Many of the global business services, including the European Treasury Centre, Market Supply Operations and Commercial Operations have a presence in Ireland.

Ireland is also home to External manufacturing's global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO's) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.

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.

For more information about Bristol Myers Squibb, visit us at ~~~/ie

The Role

Bristol Myers Squibb is looking to recruit on a permanent contract Scientist, Analytical Strategy & Lifecycle to join our team in Dublin Ireland or Devens in the US.

A Scientist in the Analytical Strategy & Lifecycle bio group plays a supporting role for Biologic product lifecycle activities. This position focuses on providing support to commercial and late stage products with a specific focus on Analytical Strategy & Lifecycle strategy, enabling regulatory filings, provide technical partnership for quality control laboratories around the world, support managing the lifecycle of specifications (methods and acceptance criteria), and authoring responses to health authority questions on commercial products.

The scientist will operate in a matrix team responsible for technical SME support to QC, preparation of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions. Through strong leadership and a level of independence, the scientist will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and our partners at outside testing labs. The scientist is responsible for data gathering, interpretation and presentation to support decision making, and product analytical strategies.

Key Duties & Responsibilities:

• Cross-Functional Collaboration: Establish and maintain effective partnerships with stakeholders across analytical development, manufacturing, supply chain, regulatory, quality, and other relevant departments to deliver high-quality analytical strategies.

• Subject Matter Expertise: Can serve as a QC technical point of contact for project activities, supporting evaluations of methods and data to support project goals.

• Method Lifecycle Management: Support analytical activities for late-stage and commercial programs, ensuring robust method performance and compliance with regulatory standards.

• Regulatory Support: Contribute to regulatory filings (BLAs, ROW, PAS) and respond effectively to Follow-Up Measures (FUMs) and Post-Marketing Commitments (PMCs).

• Method Troubleshooting and Optimization: Provide technical support to QC teams for method troubleshooting, tech transfers, validations, and investigations. Periodically review method performance and lead remediation efforts as needed.

• Change Control and Strategy Implementation: With guidance from superior, support in the implementation of control strategies, analytical method changes, and specification adjustments across the BMS network, third-party manufacturers, and external testing laboratories.

• Contribute to improvement projects of low to moderate complexity, aimed at enhancing efficiency, compliance, and method robustness

• Serve as a technical liaison, facilitating effective communication and collaboration between QC and other departments, enhancing cross-functional understanding and operational synergy.

Qualifications, Knowledge and Skills required:

• Requires working knowledge of the relevant principles and concepts of Analytical Strategy & Lifecycle (JOS / Analytical Procedures / Method Validation etc.) and associated GMP's.

• Understanding and industry hands-on experience with a broad range of assays for testing and characterizing biological products, such as HPLC, iCIEF, gel and capillary electrophoresis, and various spectrometry techniques (e.g., MS, absorption), along with ELISAs.

• An understanding of method qualification and validation, underpinned by an understanding of regulatory guidelines and a commitment to cGMP laboratory operations, ensuring compliance across all activities.

• Demonstrated ability to collaborate effectively with remote colleagues and within a matrix organizational structure, supported by excellent written and verbal communication skills.

• Demonstrated capability to analyze complex data and draw actionable conclusions, coupled with proficiency in authoring formal reports, technical documents, and scientific communications, highlighting strong analytical and writing skills.

• Ability to work independently on a majority of Analytical Strategy & Lifecycle tasks, showing a degree of initiative and responsibility in a regulatory-compliant manner

Education/Experience/ Licenses/Certifications:

• A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 2, 6 or 8 years of biologics experience within Analytical Strategy & Lifecycle / relevant field, respectively

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.

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

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 ~~~ . 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.

Company: Bristol-Myers Squibb

Req Number: R1582340

Updated: 2024-06-19 01:56:48.596 UTC

Location: Devens-MA

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.