Cell Therapy Manufacturing Associate II

Biopharma Careers; Leiden; On-site; EUR 42,000 - 64,000; Full time

Job summary

Bristol Myers Squibb Netherlands is recruiting for Associate II Manufacturing, Cell Therapy to support routine manufacturing operations in Leiden. The role requires knowledge of cGMP and working on-site in a state-of-the-art cell therapy facility.

You will collaborate with diverse teams to ensure safety, quality and regulatory compliance across multiple shifts. We seek candidates with 1+ years in cell therapy manufacturing, strong problem-solving skills, and the ability to work in a fast-paced

Qualifications

• Associate or bachelor's degree in related field is preferred.
• A minimum high school diploma and/or equivalent combination of education and experience is required.
• MBO 3 of 4 in science related field and/or equivalent Experience
• 1+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
• Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired
• Demonstrated aptitude for engineering principles and manufacturing systems
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications
• Demonstrated good interpersonal skills, is attentive and approachable
• Maintain a professional and productive relationship with area management and co-workers
• Preferred Experience: Cell therapy manufacturing, including cell washing processes and automated equipment; cell separation techniques and automated equipment; cryopreservation processes and equipment
• Cell expansion using incubators and single use bioreactors

Responsibilities

• Learn and execute Cell Therapy Manufacturing operations
• Perform patient process unit operations and support operations described in SOPs and batch records
• Execute transactions and processes in all electronic systems
• Prioritize safety of self and others
• Report safety events within 24 hours
• Escalate any issues that may impact safety
• Complete documentation required by controlled documents and batch records
• Work in line with safety policies, SOPs, quality systems, and GMP requirements
• Complete training to ensure necessary technical skills
• Train for proficiency in process systems and supporting business systems
• Execute daily unit operations schedule across multiple shifts
• Work in a controlled cleanroom environment and perform aseptic processing
• Refine and improve manufacturing process techniques
• Ensure training completion prior to production
• Demonstrate strong practical and theoretical knowledge
• Collaborate with support groups on recommendations and solving technical/operational problems
• Train others on SOPs and Work Instructions to complete operations

Skills

cGMP cell therapy manufacturing

Bioprocessing manufacturing

Manufacturing systems

Team collaboration

Quality systems

Education

Associate or bachelor's degree in related field

MBO 3/4 in science related field

Tools

Word processing

Spreadsheet

Web-based applications

Job description

Bristol Myers Squibb Netherlands is recruiting for Associate II Manufacturing, Cell Therapy to support routine manufacturing operations in Leiden. The role requires knowledge of cGMP and working on-site in a state-of-the-art cell therapy facility.

You will collaborate with diverse teams to ensure safety, quality and regulatory compliance across multiple shifts. We seek candidates with 1+ years in cell therapy manufacturing, strong problem-solving skills, and the ability to work in a fast-paced