Manager, Computer System Validation, Cell Therapy at Bristol-Myers Squibb

Summit, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
Strong working knowledge of SDLC principles and standards
Ability to work with the end user to identify and document User and Functional Requirements
Knowledge of pharmaceutical laboratory and manufacturing systems
Experience executing equipment qualification documents
Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups
Strong working knowledge of MS Windows client and server technologies
Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion
Ability to effectively manage multiple tasks and activities simultaneously
Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports
Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task
Ability to effectively communicate with employees, contractors, and vendors
Experience with technical writing and document development / generation
Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification
Competencies: Technical / Professional Knowledge, Problem Solving / Troubleshooting, Action Oriented, Attention to Detail, Multi-tasking, Building Relationships
BS degree or equivalent experience
Minimum 5 years of experience in FDA-regulated industry

Responsibilities

Supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers
Carries out routine tasks and functions, and uses strong analytical skills to recognize and solve common problems of various degrees of complexity and scope
Interacts with immediate supervisor and personnel within own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization
Through hands-on leadership, directly responsible for individual and team-based efforts, projects, and other tasks
Fosters a productive, learning environment for colleagues and reports while ensuring timely completion of assigned work
Maintains all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures
Supports equipment qualification and validation activities

Skills

Key technologies and capabilities for this role

Computer System ValidationCSVCell TherapyManufacturing EquipmentLaboratory EquipmentComputerized Systems

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What are the key skills required for the Manager, CSV Cell Therapy role?

Key skills include excellent understanding of cGXP requirements and good documentation practices, strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance, strong working knowledge of SDLC principles, and strong written and verbal communication skills.

What is the company culture like at Bristol Myers Squibb?

The culture emphasizes challenging, meaningful, and life-changing work in a flexible environment with high-achieving teams, opportunities for growth, and a focus on balance and flexibility.

What makes a strong candidate for this position?

A strong candidate has hands-on leadership experience, strong analytical skills to solve complex problems with minimum supervision, and the ability to foster a productive learning environment while managing multiple tasks in a high-paced setting.

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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