Senior Scientist in Analytical Sciences and Projects
vor 1 Monat
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.
As a Senior Scientist in Analytical Sciences and Projects, you will be part of a team responsible for the lifecycle management of the commercial specifications andanalytical methods of the small molecule portfolio.?You will also be responsible forQC lab method support & troubleshooting, method validations & transfers, lifecycle method monitoring & remediation; as well asanalytical CMC strategy supporting product globalization.? This work involves managing the analytical sections of the world-wide dossiers, authoring and reviewing regulatory filings, and responding to health authority inquiries.?
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Major Duties & Responsibilities:
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, and lifecycle method monitoring.? Additional duties will be managing specifications, authoring and reviewing regulatory filings and responding to health authority inquiries.?
Create and maintain effective partnerships with stakeholders from Quality, Pharmaceutical Development, Internal QC laboratories, External QC and Manufacturing teams, Global Regulatory Sciences, Manufacturing Sciences and Technology, and Supply Chain to deliver analytical strategies with a high probability of technical and regulatory success.?
Maintain and establishanalyticalstrategies for product globalization and commercial lifecycle management of specifications and analytical methods,??
Manage change controls as needed for the implementation of analytical changes throughout the BMS network, third party manufacturing and outside testing labs.?
Review documents and analytical sectionsof regulatory submissions and with support prepare/review responses to questions raised by Health Authorities.?
Collaborate with development teams during commercialization to become commercial method SME and ensure commercial method readiness.? Provide analytical technical support during Launch activities.?
Provide technical expertiseto QC testing sites (internal BMS and external) during method validations, transfers, routine testing and investigations.???
Lead method transfers and validations, review data and assure methods are appropriately implemented at the QC labs supporting commercial manufacturing.?
Support global expansion of commercial programs by leading in-country method transfers and contributing to global submissions.?
Perform periodic method validation and performance reviews throughout the program's lifecycle to ensure consistent and robust performance. Remediate methods as necessary if issues identified during routine analysis and periodic reviews.???
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Experience/Knowledge:?
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 substance and drug products.???
Experience inperforming method validations and transfers, as well as troubleshooting method issues.?
Knowledge of current regulatory principles and guidelines, including cGMPs, as they apply to the analytical laboratory.?
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Skills/Competencies:
Strong written, verbal and interpersonal communication skills.?
Ability to work in a matrix organization.?
Strong decision-making skills?
Proficiency in general IT tools (MS office)?
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Education/Experience/ Licenses/Certifications: ?
BA/BS in science with at least 5 years; or MS in science with 3-5 years; or Ph.D. with at least 2 years of relevantpharmaceutical experience in the industry. ?
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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 Write an email. 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.
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