Technical Lead Manufacturing, Cell Therapy at Bristol-Myers Squibb

Leiden, South Holland, Netherlands

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

General understanding of Good Manufacturing Practices (GMPs)
Goal-oriented and flexible, with ability to work effectively and efficiently on a team
Demonstrate safety, quality, and GMP compliance at all times
Qualified as a deviation Lead investigator for medium and high complex investigations across all manufacturing unit operations
Qualified trainer for all GMP operations, closed and open operations, including all grade B aseptic handling
Strong practical and theoretical knowledge in work area
Proficient in process systems and supporting business systems
Complete training assignments to ensure necessary technical skills and knowledge
Innovative and intellectually curious

Responsibilities

Execute operations described in Standard Operating Procedures (SOPs) and batch records
Lead the matrix FLS (frontline support team) across departmental team (QA, QC, F&E, IT, MFG, MSAT, SC&L)
Responsible for schedule adherence, cycle time, and issue resolution; report variances and communicate/mitigate impact to cross-functional groups
Own deviations and lead investigations / CAPA development
Lead investigator for medium and complex investigations (technical, compliance, and EHSS)
Owner of GMP documentation, controlled documents, and batch records
Responsible for manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Solve complex problems; take new perspectives using existing solutions; operational troubleshooting
Production planning to execute daily unit operations schedule including people, product, and material flow across multiple shifts as needed
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
Guide team members in issue resolution
Execute transactions and processes in all electronic systems
Perform tasks consistent with safety policies, SOPs, quality systems, and GMP requirements
Set up manufacturing areas and equipment/fixtures as needed
Collaborate with support groups on recommendations and solving technical problems
Ensure shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule
Collaborate closely with Managers to ensure seamless pass down and communication of operational status
Complete change acts

Skills

GMP

SOP

Batch Records

Deviation Investigation

CAPA

Schedule Adherence

Issue Resolution

Cross-Functional Leadership

Cell Therapy Manufacturing

MSAT

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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