Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

BSc and/or MSc degree in Science or Chem/Bio Engineering
Minimum 1+ years of industry experience
cGMP experience
Ability to perform gowning activities and enter the manufacturing plant
Tolerance for exposure to strong magnetic fields commonplace in manufacturing areas

Responsibilities

Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign support for variable shifts (Panama schedule, 0600 to 1800 or 1800 to 0600 variable shifting of days coverage)
Facilitates deviation prevention and deviation closure through site quality systems
Analyze and summarize manufacturing data to support impact assessments and investigations
Owner of change controls for routine process and procedure changes
CAPA owner for Manufacturing improvements
Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
Participates in technology transfer efforts for new processes and product implementation
Train and support GMP operators on new procedures, processes, and changes
Applies continuous improvement tools to identify and close procedural and compliance gaps
Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
Interfaces with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments

Skills

Key technologies and capabilities for this role

GMPCell TherapyManufacturingProcess EngineeringTroubleshootingRoot Cause AnalysisDeviation ManagementProcess Tech TransferEquipment Support

Questions & Answers

Common questions about this position

What shifts are available for this position?

Shifts available include 1 Day Shift (6am-6pm) and 3 Night Shifts (6pm-6am), both on a rotating schedule including holidays and weekends.

What is the salary range for this role?

This information is not specified in the job description.

What are the main responsibilities of this role?

Responsibilities include providing on-the-floor troubleshooting and technical support to Manufacturing, facilitating deviation prevention and closure, analyzing manufacturing data for investigations, owning change controls and CAPAs, and authoring/revising SOPs.

What is the work environment like at Bristol Myers Squibb?

The work environment is challenging, meaningful, and life-changing, with opportunities to grow alongside high-achieving teams in cell therapy, emphasizing balance, flexibility, and reimagining the future of patient cures.

What makes a strong candidate for this position?

A strong candidate has experience providing technical support in a GMP manufacturing environment, troubleshooting process and equipment issues, working with Manufacturing and Quality teams on deviations and CAPAs, and driving process improvements.

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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