Process Engineer at Bristol-Myers Squibb

Leiden, South Holland, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Education/Experience/Licenses/Certifications (specifics not detailed in provided description)
Ability to work shift work
Willingness to travel occasionally for training purposes
Based in Leiden, The Netherlands

Responsibilities

Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility
Prepare for and own process validation activities
Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production
Provide technical input and act as lead investigator for process related deviations, ensuring compliance with internal standards and regulatory requirements
Author, review and approve the content of technical documentation (e.g. investigations, changes, SOPs and batch records, protocols and reports)
Act as SME and lead interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support; provide prompt input on resolution of events occurring during manufacturing; responsible for troubleshooting
Support the change initiatives and the implementation of process improvement initiatives; drive and own change controls and change actions; responsible for MSAT impact assessments
Support the Technology Transfer and production of BMS CAR-T products for both global clinical trials and commercial supply
Support process validation activities
Collaborate with SMEs from the Development, Manufacturing, and Quality teams
Provide key technical support during the technology transfer stage of projects
Support the resolution of process deviations, the evaluation and implementation of process changes
Provide continuous improvement support to Manufacturing Operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products

Skills

Key technologies and capabilities for this role

Process EngineeringCell Therapy ManufacturingProduction OptimizationBiomanufacturingGMP

Questions & Answers

Common questions about this position

What is the location for this Process Engineer position?

This position is based in Leiden, The Netherlands.

Is remote work available for this role?

This information is not specified in the job description.

What are the main responsibilities of the Process Engineer?

The Process Engineer supports technology transfer and production of BMS CAR-T products for clinical trials and commercial supply, acts as process SME collaborating with Development, Manufacturing, and Quality teams, resolves process deviations, implements changes, and provides continuous improvement support to Manufacturing Operations.

What is the work schedule like for this position?

Shift work may be required for this position, with occasional travelling for training purposes.

What is the company culture like at Bristol Myers Squibb?

Bristol Myers Squibb offers a challenging, meaningful, and life-changing work environment with opportunities to grow and thrive alongside high-achieving teams, emphasizing balance, flexibility, and competitive benefits.

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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