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Senior Principal Scientist
Apply locations Summit West - NJ - US New Brunswick - NJ - US time type Full time posted on Posted 16 Days Ago job requisition id R1582246

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 .

Our 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 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 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 Senior Principal Scientist will be an CMC analytical lead (CMC-AL) for drug candidates across all stages of development and, as needed, within our commercial product portfolio. They will serve as a member of a cross functional CMC team responsible for analytical related CMC strategy development. Collaborating with various functional areas, they will identify drug substance and drug product critical quality attributes and establish controls and testing to deliver quality products.

They will drive analytical controls adhering to ICH guidelines and Health Authority requirements. The Senior Principal Scientist will have a direct impact on the division and also influence in the broader BMS community.

Role & Responsibilities:

The Senior Principal Scientist will primarily be an individual contributor and leader of a matrix team of analytical scientists, and a core member on 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 for the product quality.

• Understanding of product critical quality attributes and establish methods, specifications, analytical control strategies for product development.
• Serve on a cross functional team responsible for analytical related CMC strategy development.
• Review and discuss analytical results and conclusions both orally and in writing.
• Author/ review/approve reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
• Provide leadership and mentoring to scientific staff. Develop, coach and mentor others in matrix environment.

Desired Experience:

Required:

• Completed BS and 12-15 years; MS and 9-12 years; or Ph.D. and 6-8 years of experience in Chemistry (or relevant discipline) with pharmaceutical experience.
• A demonstrated record of scientific accomplishment, laboratory experimentation, publications, and presentations.
• Understands writing/approval of risk assessments and understands both GMP and GLP requirements for drug product development.
• Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug product development
• Mastery of chemistry with extensive expertise in measurement science.
• Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms, topicals, parental etc.).
• Knowledge of dissolution method development and testing, and biopharmaceutical assessment.
• In-depth knowledge on method development, validation, and tech transfer.
• Well versed in ICH and country specific requirements to support analytical control strategy.
• Experience in managing external manufacturing and testing laboratories as required for the product.
• Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer.
• Experience in worldwide commercialization of small molecule drug products, with recent approvals in major markets. The ideal candidate would have a history of drug approvals as an analytical expert in both drug substance and drug product analytical development.

Ideal Candidates Would Also Have:

• Exceptional verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
• Familiar with modern laboratory equipment and automation.
• Understands and applies Quality by Design principles when required.
• Experience leading Matrix teams.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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

BMS has a diverse 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.

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

W e’re creatinginnovative 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.

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