Senior Principal Scientist, Upstream Process Development at Bristol-Myers Squibb

New Brunswick, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biopharmaceuticals, PharmaceuticalsIndustries

Requirements

Expertise in developing high-performance upstream processes for recombinant protein production, including complex fusion proteins, bi-specific antibodies, and antibody drug conjugates
Proficiency in using sound scientific and engineering methodologies to establish robust upstream process platforms and toolboxes for early-stage programs
Experience working closely with Cell Line Development (CLD) and Downstream Process Development (DSP) teams to streamline workflows
Knowledge of Quality by Design (QbD) principles for process characterization in late-stage programs and developing control strategies for commercial processes
Ability to lead pilot scale runs with single-use bioreactors for scale-up testing and material generation (e.g., for GLP toxicity studies)
Experience supporting tech transfer to internal clinical manufacturing and external CMOs, including risk assessments and mitigation strategies
Capability to provide process implementation support (PIP) for manufacturing activities and troubleshooting
Experience participating as a Drug Substance (DS) representative in cross-functional CMC teams, including with external CMOs
Skills in evaluating new technologies, including external collaborations

Responsibilities

Leading a team supporting upstream process development projects, including clone selection, platform fit, process optimization, characterization, scale-up, and tech transfer for clinical manufacturing
Overseeing support for IND/IMPD and other regulatory filings, authoring technical reports
Contributing to ongoing platform improvement and technology development within the upstream workflow
Developing high-performance upstream processes for recombinant protein production, including complex fusion proteins, bi-specific antibodies, and antibody drug conjugates
Establishing robust upstream process platforms and toolboxes for early-stage programs using scientific and engineering methodologies
Collaborating with CLD and DSP to streamline overall workflows
Leading projects/initiatives for continuous improvement or development of new approaches/technologies of strategic importance
Applying QbD principles in process characterization studies for late-stage programs and jointly developing control strategies for commercial processes
Leading pilot scale runs with single-use bioreactors for scale-up tests and material generation
Supporting tech transfer activities to internal and external manufacturing sites, including risk assessments and mitigation strategies
Providing PIP support for manufacturing activities and troubleshooting
Participating as a DS representative in cross-functional CMC teams to advance programs to milestones
Evaluating new technologies, including external collaborations

Skills

Upstream Process Development

Cell Line Development

Downstream Process Development

Biologics Manufacturing

Analytical Methods

Process Optimization

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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