Sr Manager, Patient Material Operations (Manufacturing Shared Services) at Bristol-Myers Squibb

Summit, 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

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

Leadership experience managing a team of Managers, Team Leads, and Material Handlers in CAR T clinical and commercial operations
Expertise in Patient Materials processes, including Apheresis Material Receipt and Drug Product (DP) Packout in a cGMP multi-cleanroom suite
Knowledge of FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs, and applicable regulations, policies, and certifications
Ability to ensure complete traceability, efficient operations, and compliance with training, documentation, SOPs, and corporate policies
Capability to lead across multiple production areas and shifts (e.g., future 12hr/7d operations), including overnight shift (Monday-Friday, 5 p.m.-1 a.m., subject to change)
Hands-on expert knowledge of Cell Therapy production steps and Unit Operations
Commitment to safety, compliance, innovation, and Continuous Improvement culture

Responsibilities

Ensure compliant and efficient completion of production tasks for Cell Therapy products according to cGMPs, SOPs, and Work Instructions
Take personal responsibility for safe work practices, drive team accountability, perform regular safety Gemba walks, identify hazards, and demonstrate safe equipment operation
Accountable for Production Records/Process Documentation, including executing/performing batch record reviews (BRR) or Electronic Batch Record reviews, ensuring ALCOA+ principles
Perform Cell Therapy production steps to maintain hands-on expertise, role model good execution and behaviors, and backfill resources as needed to meet production schedules
Provide Production Scheduling team with daily, weekly, and monthly information on production resource availability and task execution/progression
Define team priorities, adjust as necessary to align with site/functional priorities, establish team goals, monitor/measure/assess performance and completion of production activities, and report performance metrics

Skills

cGMP

CAR T

Apheresis

Material Handling

Cleanroom Operations

Traceability

Production Processes

Team Leadership

Clinical Operations

Commercial Operations

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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