Senior Principal Scientist, Analytical Chemistry

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 135,950 - 164,738; Full time

Benefits offered by this job

Health Coverage

401(k) Plan

Disability Insurance

Life Insurance

Paid Time Off

Employee Assistance

Job summary

Bristol Myers Squibb in New Brunswick, NJ, seeks a Senior Principal Scientist as CMC Analytical Lead to drive analytical strategy across development stages and the commercial portfolio.

The role shapes CQAs, control strategies, and regulatory submissions, coordinating with Analytical, Drug Substance, and Regulatory functions to ensure product quality and compliance.

Qualifications

• BS with 12–15 years, MS with 9–12 years, or PhD with 6–8 years of pharmaceutical experience in chemistry or related discipline.
• GMP and GLP requirements and risk assessment processes.
• Experience supporting regulatory submissions and building CMC dossiers.
• Experience with commercialization of small molecule, biologics, and/or ADC drug products.
• Experience managing external manufacturing and testing labs.

Responsibilities

• Lead analytical strategy development as a core member of cross‑functional CMC teams.
• Define product critical quality attributes and establish methods, specifications, and analytical control strategies.
• Collaborate across Analytical, Drug Substance, Drug Product, Quality, and Regulatory functions.
• Review, interpret, and communicate analytical results and conclusions.
• Author, review, and approve technical reports to support regulatory submissions.
• Respond to regulatory authority questions related to analytical strategy and data.
• Provide leadership, coaching, and mentoring to scientific staff within matrix teams.

Skills

Analytical method development

Regulatory submissions

Cross-functional collaboration

Leadership coaching

Analytical chemistry

Education

BS in chemistry

MS in chemistry

PhD in chemistry or related field

Job description

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. Take your career farther than you thought possible.

Team Overview

Our Analytical Science and Operations team creates transformative medicines for 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 execute 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 through successful commercial launch.

Position Summary

The Senior Principal Scientist will serve as a CMC Analytical Lead (CMC‑AL) for drug candidates across all stages of development, as well as within the commercial product portfolio as needed. This role is a key member of cross‑functional CMC teams responsible for analytical strategy development. The incumbent will collaborate across functions to identify critical quality attributes (CQAs) for drug substance and drug product and establish control strategies to ensure product quality. The role drives analytical controls in alignment with ICH guidelines and global regulatory requirements and has significant influence across the division and broader organization.

Role and Responsibilities

• Lead analytical strategy development as a core member of cross‑functional CMC teams.
• Define product critical quality attributes and establish methods, specifications, and analytical control strategies.
• Collaborate across Analytical, Drug Substance, Drug Product, Quality, and Regulatory functions.
• Review, interpret, and communicate analytical results and conclusions.
• Author, review, and approve technical reports to support regulatory submissions.
• Respond to regulatory authority questions related to analytical strategy and data.
• Provide leadership, coaching, and mentoring to scientific staff within matrix teams.

Required Qualifications

• BS with 12–15 years, MS with 9–12 years, or PhD with 6–8 years of pharmaceutical experience in chemistry or related discipline.
• Demonstrated scientific accomplishments including publications and presentations.
• Experience with GMP and GLP requirements and risk assessment processes.
• Strong expertise in synthetic chemistry, drug substance and drug product development.
• Extensive experience in analytical method development, validation, and technical transfer.
• Experience with analytical testing across a variety of dosage forms.
• Knowledge of dissolution methods and biopharmaceutical assessment.
• Familiarity with ICH and global regulatory requirements.
• Experience supporting regulatory submissions and building CMC dossiers.
• Experience with commercialization of small molecule, biologics, and / or ADC drug products.
• Experience managing external manufacturing and testing labs.

Preferred Qualifications

• Strong communication and interpersonal skills.
• Experience working in matrixed team environments.
• Familiarity with modern laboratory equipment and automation.
• Knowledge and application of Quality by Design (QbD) principles.

Compensation Overview

Devens - MA - US: $145,470 - $176,274

New Brunswick - NJ - US: $135,950 - $164,738

The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well‑being and Protection: 401(k) plan, short‑and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work‑life benefits include

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays; not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part‑time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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.

Supporting People with Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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/

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.

R1603904 : Senior Principal Scientist, Analytical Chemistry