Principal Scientist, Analytical Development, Cell Therapy at Bristol-Myers Squibb

Seattle, Washington, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

PhD with 5+ years (or BS with 12+ years) of experience in pharmaceutical research, development, or related industry experience
In-depth knowledge and hands-on experience in development and validation of ligand binding assays (e.g., ELISA, MSD, AlphaLISA, Simple Plex, Luminex)
Proven experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, MSD Workbench, Excel)
Ability to work effectively in a collaborative team setting and in a rapidly changing environment with frequent changes in priorities
Good knowledge of cGMP and ICH/FDA/EMEA guidance
Highly motivated, self-driven, with significant hands-on experience in ligand binding/antibody assay development
Capability in collaborating with groups such as discovery research, product sciences, process development, and QC
Preferred: Experience working in a cGMP environment and/or performing analytical method validation and transfers to a QC facility

Responsibilities

Act as subject matter expert to develop, optimize, validate, and troubleshoot assays used for vector and cell therapy products
Design and execute phase appropriate validation, and manage method transfer from CTAD to internal or external QC/testing groups
Maintain meticulous laboratory notebooks and manage routine sample analysis requests
Represent the group and present data to cross functional meetings
Author, review and approve technical documents, including methods, protocols, reports, and regulatory submissions
Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc
Complete regulatory, site, and department training requirements on a timely basis
Independently develop and execute plate-based assays to support process development, characterization, and release of autologous and allogenic cell therapies
Design and analyze experiments with minimal supervision, leading to the development of robust analytical methods
Develop QC methods for lot release testing, characterization methods for product understanding, and routine testing to support process development and comparability assessments

Skills

assay development

plate-based assays

cell therapy

analytical development

method validation

QC methods

process development

lot release testing

characterization methods

troubleshooting

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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