NIGHT SHIFT: Senior Manufacturing Associate, Cell Therapy in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Requirements

Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
Ability to work assigned shift (6pm - 6am rotating shift including holidays and weekends, onsite)
Ability to work in a cleanroom environment and perform aseptic processing
Comfortable being exposed to human blood components
Ability to be in close proximity to strong magnets
Experience in cell therapy manufacturing, including cell washing processes and automated equipment

Responsibilities

Execute operations described in standard operating procedures and batch records
Demonstrate strong practical and theoretical knowledge in work
Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
Solve simple problems; take new perspectives using existing solutions
Perform tasks consistent with safety policies, quality systems, and GMP requirements
Complete training assignments to ensure necessary technical skills and knowledge
Train others on SOPs and Work Instructions to successfully complete manufacturing operations
Support investigations and identify innovative solutions
Assist in setting up manufacturing areas and equipment/fixtures
Perform facility and equipment commissioning activities
Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Work with production planning to execute daily unit operations schedule including people, product, and material flow across multiple shifts
Work in a cleanroom environment, perform aseptic processing, and maintain manufacturing environmental conditions (Non-Viable Particulates and Viable microbial levels per controlled area classification specifications) by performing area disinfection regimen as required to meet global Health Authority requirements

Skills

Key technologies and capabilities for this role

Cell TherapyGMPManufacturing OperationsProduction Line OptimizationQuality Control

Questions & Answers

Common questions about this position

What shift is required for this Senior Manufacturing Associate position?

The role is night shift from 6pm - 6am, rotating including holidays and weekends, and must be performed onsite.

What are the key responsibilities of this role?

Responsibilities include executing operations from SOPs and batch records, completing documentation, performing tasks per safety, quality, and GMP requirements, training others on SOPs, supporting investigations, and assisting in manufacturing setup and equipment commissioning.

What skills or qualities are they looking for in candidates?

They seek enthusiasm, intellectual curiosity, scientific rigor, goal-oriented mindset, flexibility, efficiency with safety and quality focus, and a good understanding of good manufacturing practices.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and a focus on balance, flexibility, and reimagining cell therapy to help patients.

What makes a strong candidate for this position?

Strong candidates demonstrate strong practical and theoretical knowledge, ability to solve simple problems with new perspectives, consistency with safety policies, quality systems, and GMP requirements, and experience training others on SOPs.

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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