Senior Manager, Cell Therapy Manufacturing, Breyanzi 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, PharmaceuticalsIndustries

Requirements

Expertise in Cell Therapy manufacturing processes and hands-on execution of Unit Operations
Ability to perform manufacturing tasks to demonstrate good execution, backfill for absent team members, and meet production schedules
Knowledge of Current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and Work Instructions (WIs)
Capability to own, review, author, or approve SOPs, WIs, and master batch records
Understanding of safety hazards, safe behaviors, equipment operation/maintenance, and performing safety Gemba walks
Proficiency in batch record reviews (BRR), Electronic Batch Record reviews, ALCOA+ principles, and resolving documentation errors
Experience supporting Material Review Board (MRB) data collection and decision-making
Availability for afternoon shift (3 p.m. - 11:30 p.m., Monday-Friday, onsite) and rotating weekend coverage for manufacturing operations
Leadership skills to manage Manufacturing Managers and Work Centered Teams (WCT) on a 24/7 shift schedule

Responsibilities

Leads by example and drives team adherence to BMS values: Inclusion, Accountability, Innovation, Urgency, and Passion
Ensures Manufacturing Managers and WCT members execute Cell Therapy manufacturing according to cGMPs, SOPs, and WIs
Owns, reviews, authors, or approves SOPs, WIs, and master batch records
Takes personal responsibility for safety, ensures team works safely, performs regular safety Gemba walks, and maintains equipment to prevent incidents
Accountable for Production Records produced by team, performs batch record reviews or Electronic Batch Record reviews by exception
Ensures all documentation follows ALCOA+ principles, is right first time, complete, accurate, and resolves errors to meet turnaround times
Performs Cell Therapy manufacturing to maintain hands-on expertise, demonstrate execution to new team members, and backfill as needed
Supports Material Review Board (MRB) with data collection and process expertise
Provides first-line support for technical or manufacturing issues during weekend coverage rotations
Continues to develop expertise in the field of cell therapy manufacturing

Skills

Key technologies and capabilities for this role

Cell Therapy ManufacturingManufacturing OperationsTeam ManagementSafety ComplianceContinuous ImprovementGMPShift ManagementProduction Oversight

Questions & Answers

Common questions about this position

What shift is available for this Senior Manager role?

The position is for the onsite Afternoon Shift from Monday to Friday, 3 p.m. to 11:30 p.m.

What are the BMS values that the Senior Manager must lead their team to adhere to?

The role requires leading by example and driving the team to adhere to BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion.

What is the salary range for this position?

This information is not specified in the job description.

What are the key responsibilities related to GMP for this role?

The Senior Manager is accountable for ensuring Manufacturing Managers and Work Centered Teams execute cell therapy manufacturing according to cGMPs, following approved SOPs and Work Instructions, and is responsible for owning, reviewing, authoring, or approving SOPs, WIs, and master batch records.

What experience or background makes a strong candidate for this role?

Strong candidates will have leadership experience managing Manufacturing Managers and Work Centered Teams in a 24/7 cell therapy manufacturing environment, with expertise in cGMP compliance, safety practices, batch record reviews, and fostering a culture of safety, innovation, and continuous improvement.

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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