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Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, hematology, immunology, cardiovascular, fibrosis and neuroscience.
Our employees work every day to transform patients’ lives through science. We’re always looking for people who want to change lives. Bold, focused, innovative and passionate people who bring unique talents to the team’s mission.
We are committed to recruiting, developing, and retaining top talent so you can pursue innovative ideas and perform your best. Join us as we transform patients’ lives through science.
For additional information's about our career opportunities, visit us at: https://careers.bms.com or https://careers.bms.com/nl
If you want to know more about our upcoming CAR T Manufacturing facility in Leiden, please visit:
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 rich in diversity. 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.
The MSAT Process Engineer is responsible for supporting the production of CAR-T products for both global clinical trials and commercial supply. Serves as process SME. Collaborates with SMEs from the Development, Manufacturing, and Quality while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Expert knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations
Deep knowledge of facility/clean room design, process, equipment, automation
Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
Experience working with external parties and/or leading cross-functional teams
Possess strong verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
Education and Experience:
Experience with the start-up, process transfer and set up of the new manufacturing facilities
Bachelor’s Degree in science or engineering (advanced degree is preferred)
5 or more years of manufacturing support or related experience in the biopharmaceutical industry
DUTIES AND RESPONSIBILITIES:
Interface with operators and serve as process SME.
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 investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
Sponsor and support the change initiatives and the implementation of process improvement initiatives
Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
Interact with other teams including Validation, Development, Operations, QA and Regulatory
Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
Reporting to the Senior Manager, or designee, the Senior Specialist performs duties required to support validation activities for our new Cell Therapy Facility and ensures protocols and reports are in compliance with BMS requirements.
This member will be responsible for coordinating and managing Installation, Operational and Performance qualification (IQ/OQ/PQ) activities when required.
Write protocols, perform field executions, and create final reports for:
Analytical Instruments/Equipment/utilities/facilities system qualifications;
Mapping studies for controlled temperature units (CTUs), warehouse and cold rooms;
Smoke studies or air flow visualization studies;
Communicate progress effectively
Ensure process and project documentation is accurate and updated;
Follow company policies and procedures;
Review and approve protocols, reports, and investigation reports;
Ensure accuracy of data presented in protocols and reports;
Ensure data is recorded / reviewed using good documentation practices (GDP);
Coordinate and communicate with area owners to ensure completion of requalification and qualification activities;
Engage in and contribute to continuous improvement projects.
Qualifications & Experience
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and good documentation practices;
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment;
Direct experience or close familiarity with analytical instruments/equipment/utility/facility qualifications and general commissioning, qualification and validation practices are desired;
Direct experience or close familiarity with investigations, deviations and CAPA management in a regulated pharmaceutical industry;
Excellent project management, communication, and technical writing skills are required.
BS in Engineering or Science related discipline preferred with a minimum of 1-3 years’ experience performing and/or supporting pharmaceutical application validation in a GMP environment.
Experience interacting with regulatory agents, external and/or internal auditors and thorough knowledge of cGMP in the pharmaceutical industry.
BMS is seeking to recruit a permanent Supervisor, QC Microbiology (Manager I). This role will manage the daily operations of the QC Microbiology shift, responsible for environmental/utility monitoring and QC microbiology testing and data review for in-process, release, and stability testing of commercial cell therapy drug product.
The Supervisor, QC Microbiology will also be responsible for hiring, mentoring and developing the QC Microbiology team to support business operations and employee career development. Supervisors are required to guide the personnel in their team with technical knowledge to support troubleshooting activities, provide investigation support, evaluate process/equipment data, and identify and implement process improvements.
In the start-up phase the Supervisor will support the scale-up of the Leiden CAR-T facility. The unique opportunity at this moment is to be able to focus on a project first and develop in that area as BMS builds its team. It is also a very exciting to develop the QC organization structure as well.
This role is stationed in Leiden and reports to the Director, QC Microbiology.
Supervise the QC Microbiology lab staff on shift and oversee the daily lab activities related to environmental/utility monitoring, in-process, final release, and stability testing of cell therapy drug product.
Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities.
Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements.
Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.
Own and evaluate relevant change controls, investigations, deviations, CAPAs.
Qualifications and Education Requirements:
Bachelor’s degree required, preferably in Microbiology or related science.
Several years of relevant laboratory work experience, preferably in a regulated environment.
2+ years of management and people leader experience.
An equivalent combination of education and experience may substitute.
Experience with microbiology assays and associated equipment.
Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred.
Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.
Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment.
The Specialist Quality Assurance Disposition, Leiden Cell Therapy role is responsible for quality and disposition activities in accordance with BMS policies, standards, procedures and Global cGMP. Functional responsibilities include performing operational and timely incoming material and drug product release within the inventory management system (SAP). This individual will also be responsible for maintenance and review of SOPs and act as a Subject Matter Expert in product disposition.
Participates in the startup of the Leiden Cell Therapy facility, including the development of Standard Operating Procedures, training, and business processes supporting incoming material disposition, reviewing and approving documentation.
Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis, change controls or deviation reports, to support drug product lot disposition.
Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Responsible for disposition of incoming production materials.
Responsible for preparing release package for site manufactured drug product.
Review of executed batch records.
B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry. Equivalent combination of education and experience acceptable.
Must have knowledge and experience with cGMP manufacturing, Quality, and compliance to global cGMP requirements.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Develop and implement drug product introduction and discontinuation business process for the Site. This process should oversee all related processes done at Site level that influence and enable the launch or discontinuation of a drug product for commercial and clinical distribution.
Manage the implementation of drug product introduction and discontinuation into the manufacturing facility.
Collaborate with Global functions, such as Regulatory, Patient Operations, Commercial, Artwork, etc. to coordinate all global activities with Site activities.
Liaising with Global and Site functions before, during and post product introduction/discontinuation to ensure all requirements are captured and compliantly executed.
Collaborate with Global and Local functions to ensure on time launch or discontinuation of a drug product as agreed with Regulatory and Commercial timelines.
Responsible for the oversight and coordination of the artwork readiness process including but not limited to Artwork Creation, Regulatory approvals, Artwork Purchase, Material Creation, Master Data Changes, Manufacturing Process Changes, MES Changes, SOP changes, etc. through the appropriate change control records.
Responsible for the oversight and coordination of packaging requirements including but not limited to Primary and Secondary Packaging Material, Packaging material availability with correct Regulatory approval, Material Creation, Master Data Changes, Manufacturing Process Changes, MES Changes, SOP changes, etc. through the appropriate change control records.
Expedite change controls with tight timelines to ensure business timelines are met.
Own CAPAs and provide project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.
Develop and author GMP SOPs, work instructions and training guides for own processes.
Qualifications & Experience
Bachelor’s degree in engineering, life sciences or related field.
10+ proven related work experience required in biopharmaceutical and/or biotechnology industry, with specific roles in customer service management, new product introduction and/or launch coordination.
An equivalent combination of education, experience and training may substitute.
Preferred but not required: Certification in CPIM, CSCP, and/or CLTD11.
Deep understanding and/or experience in supply chain processes, procedures, controls, and GMP requirements including introduction of changes to current approved commercial materials, introduction of new country materials, discontinuation of country materials, etc.
Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
Experience with large scale change efforts with the ability to lead strategic changes in the supply chain space including commercial organizations.
Must be adaptable, resilient with a commitment to goals and a strong sense of collaboration.
Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues at all levels across the organization.
Must possess a strong sense of urgency and accountability.
Experience with lean six sigma projects and change execution management.