Senior Scientist, Analytical Testing

Biopharma Careers; New Brunswick (NJ); On-site; USD 109,000 - 132,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Senior Scientist for Analytical Testing in New Jersey. The role focuses on method validation, cGMP compliance, and oversight to support clinical and commercial development of small molecules and IMPs.

You will lead data integrity efforts, coordinate labs, and contribute to regulatory submissions. The position requires strong communication, cross-functional collaboration, and a track record in regulatory environments with IND/NDA experience.

Qualifications

• Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field.
• Demonstrated knowledge of IND/NDA validation and troubleshooting of chromatographic separation methods.
• Excellent interpersonal communication skills for interfacing with multi-disciplinary teams.
• Experience with regulatory submissions and interaction with regulatory inspectors.
• Strong knowledge of cGMP, regulatory agency requirements and ICH compliance.

Responsibilities

• Follow GMP/GLP guidelines for data review related to method validation and testing.
• Coordinate method transfers and data acceptance from contract labs.
• Maintain audit-ready laboratory status and participate in audits/inspections.
• Prepare/approve reports for methods, validation, and technology transfer.
• Prepare/review SOPs, testing protocols, and training materials.
• Support CAPA investigations and regulatory inquiries.

Skills

Interpersonal communication

Cross-functional collaboration

Regulatory submissions experience

cGMP knowledge

Education

Bachelor's degree in analytical chemistry or related field

Master's degree in a relevant field

PhD in a relevant field

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

O ur Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting - edge science of today. Working within Global Product Development and Supply this team uses state - of - the art technologies to develop, enable and e xecute analytical and CMC strategies that ensure safety, quality and efficacy of life - saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development th rough the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.

Position Summary

The successful candidate will be part of the Analytical Regulated Testing GMP team at BMS New Jersey within Analytical Strategy & Operations. The scientist performs analytical method validation and cGMP activities and provides oversight and strategy to support clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Products.

Role & Responsibilities

• Follows GMP/GLP guidelines in the acquisition and/or review of data related to method validation and/or testing of release, stability and development materials. May be assigned to guide others in these activities.
• Applies a phase appropriate approach to GMP in laboratory work and documentation.
• May be responsible for coordination of method transfers, testing, management of and acceptance of data acquired by contract laboratories & service providers.
• Operates within and maintains the laboratory in an ‘audit ready’ status.
• Participates in audits and inspections.
• May contribute to the establishment and implementation of proper corrective actions for findings.
• Prepares, and may approve, reports for methods, validation, and technology transfer.
• Prepares and/or reviews operational procedures, testing protocols/reports and training materials.
• Practice and assist in implementation of best practices associated with laboratory Quality Systems including training, procedures, instrumentation management, and data and records management.
• May prepare and/or approves plans and tools for continuous improvement of quality and compliance.
• Identify deviations to quality systems or limits/specifications, and ensures they are addressed in a timely manner.
• Lead and participates in investigations, including the preparation and implementation of corrective actions (CAPAs).
• May prepare responses to questions from regulatory agencies related to an analytical data and procedures.
• Effective collaboration and communication with the CMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines.

Qualifications & Experience

• Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 7+ years relevant industrial experience or equivalent, or Master's degree and 4-6 years of experience, or PhD and 2-4 years of experience
• Demonstrated knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
• Excellent interpersonal communication skills with capability of interfacing with and influencing multi-disciplinary teams.
• Experience with regulatory submissions and interaction with regulatory agency inspectors.
• Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.

Competencies

• Demonstrates ability to prioritize project responsibilities to meet competing requirements.
• Ability to adapt to change, manage multiple projects effectively meeting timelines.
• Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
• Able to identify opportunities and implement solutions to improve efficiency, productivity and quality/compliance.
• Strong verbal and written communication skills to effectively communicate with key partners both internally and externally.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

New Brunswick - NJ - US: $109,270 - $132,407

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodations/adjustment prior to accepting a job offer. If you require reasonableaccommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605758 : Senior Scientist, Analytical Testing