Principal Scientist/Senior Principal Scientist, Analytical Development

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 .

Position:Principal Scientist/Senior Principal Scientist, Analytical Development
Location:New Brunswick, NJ

Drug Product Development (DPD)
Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting-edge innovation to achieve this commitment. BMS's internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities. We collaborate closely with our colleagues in R&D and Commercial to design our drug products. Here, you'll get the chance to grow and thrive through opportunities that are uncommon in scale and scope.

Position Summary
We are seeking an experienced scientist with strong analytical technical skills and a passion for strategic project leadership. This role will provide analytical subject matter expertise, drive analytical and relevant CMC strategy within cross-functional drug product development teams, to support an increasingly complex portfolio of small molecules and biologics across all stages of development. This role will be accountable as an individual contributor and as an analytical matrix team lead to support analytical method development, control strategy development, as well as providing analytical characterization support for drug product formulation and process development activities. The successful candidate is expected to be proficient in a wide variety of analytical techniques as well as with the latest ICH, FDA and EMA regulatory guidance on pharmaceutical development.

Key Responsibilities:
This individual will collaborate cross-functionally with Analytical, Drug Product, Drug Substance, Quality, and Regulatory leads to execute drug product formulation/process development support, develop phase-appropriate drug product methods and specifications, coordinate validation and transfer activities, integrate/align analytical control strategies, and support IND/NDA submission.
Serve on a cross functional team responsible for analytical related CMC strategy development.
Support drug product formulation and process development including characterization of the process and finished product.
Develop and optimize drug product analytical methods and provide guidance on method validation and transfer.
Conduct and assess developmental stability experiments to inform formulation design and packaging selection for drug products.
Review and discuss analytical results and conclusions both orally and in writing.
Write formal reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
Provide leadership and coaching to junior scientists.

Qualifications & Experience Required:
Experience in the development and performance of analytical tests for a variety of drug product dosage forms.
Extensive knowledge of HPLC / UPLC method development and validation.
Knowledge of dissolution method development and testing, biorelevant dissolution testing and biopharmaceutical classification system.
Understanding of drug product formulation and process development principles.
Experienced in supporting regulatory submissions.
Prior experience as an analytical development matrix leader.
Experience with in-vitro release of LNPs, Liposomes and Long-acting Injectables (LAI) a plus.
Regulatory experience in the justification of IVIVC methods a plus.
Experience with MS and/or CE a plus.

Other Qualifications:
Principal Scientist
Completed BS in Chemistry (or relevant discipline) with 9-12 years; MS with 6-9 years; or Ph.D. with 4-6 years of pharmaceutical laboratory experience.
A demonstrated record of laboratory experimentation and scientific accomplishment.
Understanding of risk assessment principles.

Senior Principal Scientist
Completed BS in Chemistry (or relevant discipline) with 12-15 years; MS with 9-12 years; or Ph.D. with 6-8 years of pharmaceutical laboratory experience.
A demonstrated record of laboratory experimentation and scientific accomplishment.
Understanding of risk assessment principles.

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.
Capability to adapt and grow within a dynamic environment. Leverage technical expertise, collaborate with SMEs / project team to drive problem solving and knowledge gathering.
Familiar with modern laboratory equipment and automation.
Understands and applies Quality by Design and other statistical principles.

Development Value:
The individual will have organizational and interdepartmental responsibilities with regards to leading workgroups, cross-functional teams, strategy development/implementation/execution, and cultural initiatives.

#GPSProdDev

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto 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.

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