Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing at Bristol-Myers Squibb

Summit, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

General understanding of Good Manufacturing Practices (GMPs)
Goal-oriented and flexible
Ability to work effectively and efficiently on a team
Demonstrate safety, quality, and GMP compliance at all times
Strong practical and theoretical knowledge in their work
Ability to solve complex problems and take new perspectives using existing solutions
Easily approachable and maintains a desire to build and foster relationships while working through challenges/opportunities
Complete training assignments to ensure necessary technical skills and knowledge
Proficient in process systems and supporting business systems
Qualified as a deviation investigator
Availability for Sunday - Wednesday shift (with every other Wednesday off), onsite day shift 5 a.m. - 5:30 p.m

Responsibilities

Execute operations described in Standard Operating Procedures (SOPs) and batch records
Execute transactions and processes in all electronic systems
Complete documentation required by governing controlled documents and batch records; ensure all documentation is right first time
Perform tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
Evaluate team processing performance and communicate delays to leadership; take a proactive approach in resolving issues/bottlenecks
Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
Collaborate with support groups on recommendations and solving technical problems
Ensure the shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule
Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status
Initiate deviations and support investigations/CAPA development
Complete assigned investigations timely
Complete change actions for change controls or investigations
Initiate and facilitate triage calls; provide support to Management as needed
Identify and propose innovative solutions
Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Train and qualify others on SOPs and Work Instructions to successfully complete manufacturing operations

Skills

GMP

Cell Therapy

CAR-T Manufacturing

Manufacturing Operations

Quality Compliance

Safety Protocols

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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