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Scientist, Analytical Strategy
4 months ago
**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 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.
**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.
**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, und
