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

Devens, Massachusetts, 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

Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
Ability to work assigned night shift (6pm – 6am) on a rotational schedule including holidays and weekends, onsite
Strong practical and theoretical knowledge in work
Goal-oriented, flexible, able to work efficiently with safety and quality in mind
Enthusiastic, innovative, with good understanding of good manufacturing practices
Ability to work in a cleanroom environment and perform aseptic processing

Responsibilities

Execute operations described in standard operating procedures and batch records
Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
Solve complex 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
Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities
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 Managers to ensure seamless pass down and communication of operational status
Support investigations
Identify innovative solutions
Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Train others on SOPs and Work Instructions to successfully complete manufacturing operations
Work with production planning and leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts
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

Cell Therapy

Manufacturing

GMP

Good Manufacturing Practices

Production Operations

Night Shift

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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