Senior Associate II Manufacturing, Cell Therapy

Bristol-Myers Squibb; Leiden; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Competitive benefits

Opportunities for career growth

Job summary

A leading biopharmaceutical company in Leiden is seeking a Senior Manufacturing Associate to support routine operations in cell therapy manufacturing. This role requires a general understanding of Good Manufacturing Practices and extensive experience in a related field. Ideal candidates will demonstrate strong problem-solving abilities and effective teamwork. The position involves working in a cleanroom environment and supporting complex manufacturing processes.

Qualifications

• Must have a general understanding of Good Manufacturing Practices (GMPs).
• Extensive knowledge of cGMP regulations applicable to biologics.
• Peer-level leadership experience preferred.

Responsibilities

• Execute operations described in Standard Operating Procedures (SOPs) and batch records.
• Train and qualify others on processes, SOPs, and work instructions.
• Work in a controlled cleanroom environment executing aseptic procedures.

Skills

Good Manufacturing Practices (GMPs)

Problem-solving

Interpersonal skills

Engineering principles

Education

MBO 3 or 4 in science related field

7+ years of cGMP cell therapy manufacturing experience

Tools

Computer tools (word processing, spreadsheets)

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Bristol Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.

The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it!

The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.

Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer!

For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl

Position Summary

BMS Cell Therapy Manufacturing is seeking enthusiastic and passionate Senior Manufacturing Associates to join the Manufacturing team. Our Senior Manufacturing 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. The Senior Manufacturing Associate is a SME on complex manufacturing unit operations and complex business processes. 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

• Execute operations described in Standard Operating Procedures (SOPs) and batch records
• Demonstrate strong practical and theoretical knowledge in their work
• Complete documentation required by governing controlled documents and batch records
• SME on complex manufacturing unit operations and complex business processes
• SME on supporting processes
• Complies with Source Governing Documents (SGDs)
• Solve complex problems; takes new perspectives using existing solutions
• Perform 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
• Proficient in process systems and supporting business systems
• Train and qualify others on processes, SOPs, Work Instructions to successfully complete manufacturing operations
• Completes Notice of Events, Minor deviations and supports and leads investigations, as required
• Works to identify innovative, continuous improvement solutions
• Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
• Author, review, approve as needed manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Partner with production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts
• Drive Right First Time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
• Aid in daily work coordination and distribution as demanded through the production schedule
• Responsible for maintaining schedule adherence and cycle time. Report variances and communicate impact to cross functional groups and Team Leads
• Ensure shift notes communications are complete and accurate
• Work in a controlled cleanroom environment and execute aseptic processing procedures (as needed). 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
• Completes change actions and MRB slides as needed or assigned
• Have a positive attitude and cultures this in the team and department.

Education/Experience/ Licenses/Certifications

• MBO 3 of 4 in science related field and/or equivalent
• 7+ 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

Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. The occupancy type that you are assigned is determined by the nature and responsibilities of your role. Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: careers.bms.com/california-residents/

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