Senior Principal Scientist, Analytical Development

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Senior Principal Scientist, Analytical Development

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locations

Summit West - NJ - US

time type

Full time

posted on

Posted 16 Days Ago

job requisition id

R1579828

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

.
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
The Senior Principal Scientist will serve as a drug product analytical lead who will drive analytical strategy and support for small molecule drug product development activities. The incumbent will be accountable as an individual contributor and as an analytical matrix team lead to support analytical method development as well as providing analytical characterization support for drug product formulation and process development activities. The Senior Principal Scientist will play an integral role as part of the drug product development organization and will provide necessary guidance and support of drug product control strategy for drug candidates across all stages of development and, as needed, within the commercial product portfolio. The individual will be proficient in multiple analytical techniques as well as with the latest ICH, FDA and EMA regulatory guidance on pharmaceutical development. The individual will be a member of a cross functional team responsible for drug product related CMC strategy development.

Key Responsibilities
The Senior Principal Scientist will collaborate across BMS sites with Analytical, Drug Product, Drug Substance, Quality, and Regulatory leads to execute drug product formulation/process development support, analytical strategies for drug product methods and specifications, analytical control strategies, and support of product development up to drug application submissions and approval.
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 to QC during validation and transfer.
Conduct and assess developmental stability experiments to inform formulation design and packaging selection for drug products.
Provide matrix leadership for scientific staff. Develop, coach and mentor others.
Will 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.
Write formal reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
Key Responsibilities
The Senior Principal Scientist will collaborate across BMS sites with Analytical, Drug Product, Drug Substance, Quality, and Regulatory leads to execute drug product formulation/process development support, analytical strategies for drug product methods and specifications, analytical control strategies, and support of product development up to drug application submissions and approval.
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 to QC during validation and transfer.
Conduct and assess developmental stability experiments to inform formulation design and packaging selection for drug products.
Provide matrix leadership for scientific staff. Develop, coach and mentor others.
Will 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.
Write formal reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
Qualifications & Experience

Required:
Experience in the development and performance of analytical tests for a variety of drug products dosage forms.
Extensive knowledge of HPLC / UPLC method development.
Knowledge of dissolution method development and testing, biorelevant dissolution testing and biopharmaceutical classification system.
Strong knowledge of chemistry with extensive expertise in measurement science.
Understanding of drug product formulation and process development principles.
Experienced in building the CMC dossier for regulatory submissions as an author/reviewer.
Prior experience as an analytical development matrix leader.
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 and other statistical principles.
Other Qualifications:
Completed BS and minimum of 15 years;

MS minimum of 12 years; or Ph.D. and minimum of 8 years in Chemistry (or relevant discipline) with pharmaceutical laboratory experience.
A demonstrated record of scientific accomplishment, laboratory experimentation, publication, and presentation.
Understands PAT and risk assessment approaches.
Development Value:
The Senior Principal Scientist will have organizational and interdepartmental responsibilities with regards to leading workgroups, cross-functional teams, strategy development/

implementation/execution,

and cultural initiatives.
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

[email protected]

. 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.
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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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