Associate II Manufacturing, Cell Therapy

Bristol Myers Squibb; Leiden; On-site; EUR 40,000 - 60,000; Full time

Job summary

Bristol Myers Squibb is hiring for a crucial manufacturing role in our cell therapy programs in Leiden, Netherlands. The selected candidates will support routine operations with a focus on safety, quality, and compliance to Good Manufacturing Practices (GMP).

Ideal candidates should have experience in cell therapy manufacturing, technical problem-solving skills, and the ability to collaborate effectively within a team. Join us to advance your career in a cutting-edge field!

Qualifications

• Minimum 1 year of cGMP cell therapy manufacturing experience required.
• Extensive knowledge of cGMP regulations and FDA guidance.
• Experience in cell therapy manufacturing processes preferred.

Responsibilities

• Execute Cell Therapy Manufacturing operations following GMP guidelines.
• Maintain cleanroom conditions and perform aseptic processing.
• Collaborate with teams to solve operational problems.

Skills

cGMP compliance

Cell therapy manufacturing

Team collaboration

Technical problem-solving

Interpersonal skills

Education

Associate or bachelor's degree in related field

High school diploma or equivalent

Tools

Microsoft Word

Spreadsheets

Web-based applications

Job description

Position Summary

We will be recruiting 23 people for this role. Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

Duties / Responsibilities

• Learn and execute Cell Therapy Manufacturing operations
• Perform patient process unit operations and support operations described in standard operating procedures and batch records
• Execute transactions and process in all electronic systems
• Prioritize safety of self and others
• Report safety events within 24 hours
• Escalate any/all issues that may impact safety of self and/or others
• Complete documentation required by governing controlled documents and batch records
• Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
• Complete training assignments to ensure the necessary technical skills and knowledge
• Train for proficiency in process systems and some supporting business systems
• Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts
• Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned). Maintain manufacturing environmental conditions (Non‑Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
• Continuously refine and improve manufacturing process technique to improve individual operational times
• Ensure training completion prior to production
• Demonstrate strong practical and theoretical knowledge
• Collaborate with support groups on recommendations and solving technical and operational problems
• Train others on SOPs and Work Instructions to successfully complete manufacturing operations

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

• Experience in 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

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.