Associate Director, Product Technical Steward, Cell Therapy Technical Operations at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Highly cross-functional leadership across all sites of Drug Product manufacture for the designated product
Ability to develop strategy for the product franchise and represent Drug Product on product strategy teams
Primary ownership of the Drug Product process, including process validation, regulatory filings, inspections and responses, technology transfers, troubleshooting, change management, process monitoring and robustness, continuous improvement
Regular interaction with product development to ensure process readiness for commercialization, assess resources, communicate progress and risks, present timelines and strategies
Representation of Drug Product manufacturing process in regulatory interactions such as inspections and meetings
Collaboration with Drug Product manufacturing site teams to troubleshoot issues and develop process improvements
Close collaboration with analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sciences
Resolution of complex problems through strong leadership of cross-functional teams to meet product quality, schedule, and cost objectives

Responsibilities

Define strategy for the product franchise by representing Drug Product on product strategy teams and leading a cross-functional technical team that creates and governs the Drug Product technical project portfolio
Collaborate with process development and analytical development to ensure early pipeline assets have a robust process
Serve as primary owner of the Drug Product process for the designated product, providing technical content and strategy across tech transfers, process validation, technical reports, data analysis, process monitoring, change control and implementation, product comparability, and escalated support of technical/scientific process and analytical issues
Provide technical content for documents such as PPQ protocol or comparability assessments, author content for regulatory submissions and annual product quality review, present technical strategies during major health authority interactions and inspections
Collaborate closely with analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy and prevent supply disruptions
Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites
Oversee implementation of lifecycle management projects

Skills

Cell Therapy

Technical Operations

Process Validation

Regulatory Filings

Technology Transfer

Change Management

Process Monitoring

Continuous Improvement

Cross-Functional Leadership

Drug Product Manufacturing

Troubleshooting

Commercialization

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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