Principal Scientist

☞ Bristol Myers Squibb

View: 180

Update day: 29-03-2024

Location: Boudry Neuchâtel NE

Category: R & D IT - Software

Industry: Pharmaceutical Manufacturing

Position: Associate

Job type: Full-time

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Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

As a Principal Scientist in Method Lifecycle Pharma, you will be part of a team responsible for the lifecycle management of the commercial analytical methods used to support the pharma, small molecule portfolio. This team resides within the Analytical Sciences and Technology organization (AS&T), which supports Global Quality for commercial products. In addition to being responsible for the lifecycle management of commercial methods, AST is responsible for creating and managing the analytical CMC strategies from late-stage development throughout the product lifecycle, validation strategy, authoring and reviewing regulatory filings, and supporting global QC and manufacturing technology groups.

This position requires working independently and within project teams under the guidance of an experienced leader. As the subject matter expert (SME) of the commercial methods you will be responsible for QC lab method support, method validations & transfers, troubleshooting, lifecycle method monitoring, remediation, and method strategy.
  • Collaborative with development teams during commercialization to become commercial method SME and ensure commercial method readiness. Provide analytical technical support during Launch activities.
  • Provide technical expertise to QC testing sites (internal BMS and external) during method validations, transfers, routine testing, and investigations.
  • Authoring method validation and transfer protocols and reports, reviewing data, and assuring appropriate implementation within global regulatory guidelines.
  • Support global expansion of commercial programs by leading in-country method transfers and contributing to global submissions and responding to health authority inquiries.
  • Perform periodic method validation and performance reviews throughout the program’s lifecycle to ensure consistent and robust performance. Remediate methods as necessary if issues are identified during routine analysis and periodic reviews.
  • Review documents and CMC Analytical section for regulatory submissions and prepare/review responses to questions raised by Health Authorities.
  • Review change control documents, compendial monographs, and proposed methods and specifications.
  • Works closely with all AS&T team members to understand and support their deliverables to achieve organization goals.
Required Knowledge/Skills/Qualifications
  • BA/BS in science with at least 7 years; or MS in science with 5-7 years; or Ph.D. with at least 4 years of relevant pharmaceutical experience
  • Demonstrated ability to perform independent work and works well within a team environment.
  • Overall awareness of the pharmaceutical manufacturing and quality processes and regulatory requirements necessary for the manufacture and distribution of pharmaceutical products.
  • Strong technology and scientific background in the application of analytical chemistry to pharmaceutical development, manufacture and control
  • Experience with chromatographic, spectroscopic, and other analytical techniques used to test and characterize small molecule drug substances and drug products.
  • Experience performing method validations and transfers, as well as, troubleshooting method issues.
  • Knowledge of current regulatory principles, including cGMPs, as they apply to the analytical laboratory.
  • Strong written, verbal, and interpersonal communication skills.
  • Ability to work in a matrix organization.
  • Strong decision-making skills
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.
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Deadline: 13-05-2024

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