Principal Scientist/Senior Principal Scientist, Analytical Development

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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.
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.
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