Director, QC Microbiology
Bristol Myers Squibb
30+ dagen geleden
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 (https://www.youtube.com/watch?v=hj8_j_FNzSU&t=19s) 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
PURPOSE AND SCOPE OF POSITION:
+ The Head of QC Microbiology at the Cell Therapy Facility (CTF) in Leiden, the Netherlands will be responsible to provide senior leadership to the QC Microbiology organization and oversee cGMP microbiological testing including environmental monitoring to ensure product safety. This individual will be a key member of the team responsible for the design, implementation and continuous improvement of all the systems and processes in support of the Leiden CTF contamination prevention program. The Head of QC Microbiology will be a key member of the CTF Quality Leadership Team and a champion for quality principles and compliance within the Leiden Cell Therapy organization.
DUTIES AND RESPONSIBILITIES:
+ Demonstrate leadership and experience for microbiology, aseptic processing and biosafety for Cell Therapy products manufactured at the Leiden Cell Therapy Facility.
+ Direct the daily operation of a QC Microbiology department testing and reporting of environmental and utility monitoring and microbiological samples to support the manufacturing of cell therapy products.
+ Define departmental roles and accountabilities. Hire, integrate and develop high quality talent capable of delivering against the department’s goals and objectives.
+ Establish and communicate performance objectives for QC Micro staff that are consistent with the business unit and Quality goals. Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment that attracts, develops, and retains the best talent.
+ Direct the training and scheduling of QC Micro staff to assure testing activities occur in an efficient and cGMP compliant manner.
+ Accountable for the efficient and timely technology transfer of test methods.
+ Direct programs or procedures which assure the proper qualification, calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends, and the completion of written investigations in response to unusual or unexpected results or deviations.
+ Direct QC department programs and projects related towards the goal of continuous improvement (e.g., Lean Labs).
+ Participate in the site team, which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of the facility and products.
+ Accountable for on time, quality laboratory investigations and associated CAPA within the electronic investigation management system (e.g. Infinity), as needed.
+ Support completion of Annual Product Quality Review and periodic investigation trending reports.
+ Verify compliance with applicable BMS Policies and Procedures and ensure consistency with other site procedures and/or specifications.
+ Responsible for managing the QC Microbiology budget.
+ Owner of the Environmental Action Committee for the review and performance of the site’s environmental controls program.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
+ B.S. degree required.
+ A minimum of 10 years in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility of a biologics, cell therapy or sterile drug product Quality Control laboratory.
+ Equivalent combination of education and experience acceptable.
+ In depth knowledge of common QC procedures, techniques, and laboratory equipment and instrumentation, and the application and interpretation of most-relevant GMP concepts and compendia requirements (e.g., EP, Eudralex).
+ Proficiency in microbiological assay methodologies including, sterility, container closure integrity, microbial identification and rapid microbiological techniques and technologies.
+ Experience with isolator technology.
+ Demonstrated leadership, interpersonal, communication, and motivation skills.
+ Experience leading and managing a large, multi-leveled organization is essential.
+ Knowledge of cell therapy or biologics manufacturing is highly desirable.
+ Extensive knowledge of EU cGMP regulations and guidance required; Additionally, knowledge of US cGMP regulations and guidance is preferred
+ Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.
+ Knowledge of applicable business systems (e.g., SAP, LIMS, LES, Maximo, and Infinity) preferred.
Why You Should Apply
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Company: Bristol Myers Squibb
Req Number: R1547696
Updated: 2021-12-06 02:41:00.246 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.