Senior Principal Scientist, Analytical Chemistry at Bristol Myers Squibb

New Brunswick, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Oct, 26

Salary

164738.0

Posted On

05 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Chemistry, CMC Strategy, Method Development, Method Validation, Technical Transfer, Synthetic Chemistry, Drug Substance Development, Drug Product Development, GMP, GLP, ICH Guidelines, Regulatory Submissions, Quality by Design, Dissolution Methods, Biopharmaceutical Assessment, External Lab Management

Industry

Pharmaceutical Manufacturing

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. 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. 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 The Senior Principal Scientist will primarily be an individual contributor and leader of a matrix team of analytical scientists, and a core member of the CMC team. The Senior Principal Scientist will collaborate across BMS sites with functional Analytical Leads, Drug Substance and Drug Product Leads, Quality Lead, and Regulatory Lead to generate and execute analytical strategies to ensure product quality. 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 diverse 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 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. 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. Compensation Overview: 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. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. 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. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. 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. 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 adastaffingsupport@bms.com. 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. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1603904 : Senior Principal Scientist, Analytical Chemistry Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Responsibilities

Serve as the CMC Analytical Lead to develop and execute analytical strategies ensuring the safety and quality of drug candidates. Collaborate across cross-functional teams to define critical quality attributes and establish control strategies in alignment with global regulatory requirements.