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Position Summary:

The Senior Scientist will serve as the designated point of contact for Aichi and the analytical network, frequently interaction with global analytical science and product development teams. The incumbent will be subject matter expert for the analytical portion of new product introduction and for a number of test methods/processes across multiple products, anticipate and perform complex troubleshooting and problem-solving independently.

The incumbent will manage and deploy, in collaboration with other QC members, continuous improvement and simplification initiatives.

This role will own generation of protocols and reports, and other documents aligned with regulatory and corporate guidelines. The Senior Scientist will also represent the department in product review boards and regulatory inspections, both internal and external, and may author responses to regulatory requests.

They will lead transfers, validations, projects, CAPAs, and deviations/investigations, and continuous improvement efforts.Furthermore, the Senior Scientist will train and mentor others on multiple QC test methods, processes, and procedures and perform other tasks as assigned.

Duties/Responsibilities

General Level Responsibilities:

• Designated Subject matter expert for a number of test methods/processes across multiple products
• Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
• May own scheduling of assignments in consultation with manager.
• Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
• Represent the department in product review boards and regulatory inspections (internal and external audits).
• May author responses to regulatory requests.
• Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts.
• Anticipate and perform complex troubleshooting and problem solving independently.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes and procedures.
• Perform other tasks as assigned.
• Owns and contributes to change controls.
• May act as delegate for laboratory management, as required.
• Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
• Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation.
• Champion and foster a positive, supportive, and collaborative quality culture.
• Actively and positively participates or leads in Operational Excellence (Op Ex) and Continuous Improvement (CI) initiatives in the team
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).

Key Job Competencies:

• Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely.
• Demonstrated advanced technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Excellent attention to detail and demonstrated organizational skills.
• Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English
• Demonstrated strategic & enterprise thinking
• Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced use and knowledge of LIMS, ELN and laboratory data analysis.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

Role Specific Assignments:

• Lead analytical test method transfer for new product launch
• Lead alignment of CoA and test method of DP site with External Manufacturing or BMS sites for MRA application
• Lead introduction of analytical instruments
• Lead Continuous Improvement Initiatives and enhancement of GMP compliance in QC lab

Qualifications:

• Bachelors Degree in a non-technical discipline with ≥13 years experience, or
• Bachelors Degree in a Scientific or relevant Technical area with ≥9 years experience, or
• Masters Degree in a Scientific or relevant Technical area with ≥7 years relevant experience, or
• PhD in a Scientific or relevant Technical area with ≥5 years relevant experience.
• Able to write, read, and speak English fluently
• An equivalent combination of education and experience, preferably in a regulated environment will be considered.

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 a supportive culture, promoting global participation 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 an 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 adastaffingsupport@bms.com. 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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