Key Skills

Job Description

Junior Expert Microbiologist Location: Leiden, The Netherlands Duration: 12 months initially with opportunity for extension Hours: 40 hours/week, Monday–Friday fully on-site Imagine your next project Lead ground-breaking microbiological verification studies and shape cleanroom impact assessments to directly advance life-saving cell and gene therapy clinical products in an international healthcare leader. The Strategic Operations (SO) group is recruiting for a (Jr) Expert Microbiologist, located in Leiden, The Netherlands. The SO group is part of the Analytical Development (AD) Department of the Advanced Therapeutics sector of J&J Innovative medicine and is responsible for a wide range of activities to support production of our new Cell & Gene therapy clinical products. These responsibilities include coordination and execution of release and stability testing, sample management, raw material release, change management, cell culture services, and assessing the controlled state of the cleanrooms and utility systems of the Advanced Therapeutic Production (ATP) facility. The SO group is a complementary team with different nationalities and backgrounds, working closely together in an international environment. We are looking for a (Jr)Expert Microbiologist with extensive knowledge and experience in Microbiology and cGMP, who enjoys working in a multidisciplinary environment with local and global stakeholders. This role is for an individual contributor who performs routine tasks independently with limited supervision and more sophisticated tasks with support from experts. roles and responsibilities Leading Microbiological method verification studies including authoring of protocols and reports, coordination of the testing by the laboratory analysts, and alignment with various local and global stakeholders Comprehensive assessment of the impact of changes in the cleanrooms and utility systems of the ATP facility on the monitoring programs, in close collaboration with the Microbiology SME and stakeholders from manufacturing operations and engineering departments Authoring and review of (re)qualification protocols and reports, and performing critical evaluation of clean room and utility monitoring trending data Effective stakeholder management and building strong relationships with collaborators Perform thorough laboratory investigations and accurate documentation of nonconformances in the quality system, ensuring that a high level of Quality is maintained within the department Support Microbiology laboratory operations by performing data review, assisting in coordination of lab activities, and providing guidance to Microbiology laboratory analysts Participate in continuous improvement projects that progresses the department in quality, EHS and efficiency gain with a large focus on digitalization Mentor, train, and influence more junior staff how to succeed A minimum of a B(A)Sc degree in Microbiology or related field, or an MBO or HBO education level At least 2-5 years of work experience in similar or related role Strong hands-on testing experience Demonstrated in-depth knowledge of applicable EU GMP, EP, USP and ISO guidelines Extensive experience within a cGMP and a Quality driven environment Excellent organizational capabilities and ability to maintain overview Ability to identify areas of improvement and optimize processes in a dynamic and growing environment Teammate with well-developed interpersonal skills and capable of maintaining positive relationships Positive and proactive mentality, enthusiastic and motivated Good communication in English (written and verbally) is mandatory + Dutch is a plus benefits This role offers a very competitive hourly rate. This contract will run for 12 months initially with opportunity for extension you are welcome here Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. about Johnson & Johnson Innovative Medicine Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. application process We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert. Diversity, Equity & Inclusion For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

Core Responsibilities

Lead microbiological method verification studies, including protocol and report authoring, testing coordination, and stakeholder alignment. Assess cleanroom and utility system changes and monitoring trends, support laboratory operations and investigations, and contribute to quality, safety, efficiency, and staff development.

Requirements

Requires a degree in microbiology or a related field, or an MBO/HBO education level, and 2–5 years of relevant experience with strong hands-on testing skills. Candidates should have in-depth knowledge of applicable EU GMP, EP, USP, and ISO guidelines, experience in a cGMP quality-focused environment, strong organizational and interpersonal skills, and written and spoken English; Dutch is a plus.