Expert Solid State & Non-Chromatographic Analytical Technologies

Expert Solid State & Non-Chromatographic Analytical Technologies

Location: Geel

Working mode: Hybrid, 3 days per week on-site and 2WFH

Duration: 6 months

Language requirements: English & Dutch

Hours: Full-time, 40 hours per week

Janssen Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM API and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. Janssen Supply Chain Quality (JSCQ) supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-API and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

As an Expert Solid State & Non-Chromatographic Analytical Technologies, you provide a comprehensive oversight on Geel QC non-chromatographic laboratories. As an expert you are involved in the interpretation of global regulatory requirements and J&J initiatives in your field to ensure the lab stays aligned with current and upcoming regulations and global J&J standards. You will be requested to assume E2E ownership on selected improvement initiatives in the analytical area by improving/generating new procedures, guidance documents and by facilitating their classroom training sessions. You drive systematic changes in the non-chromatographic area by acting as an SME for different analytical techniques and by liaising with the relevant partner organizations, such as R&D, QA, CMC RA etc. As a critical aspect of your role, you are requested to provide continuous support and coaching to lab personnel in the analytical fields assigned to you.

roles and responsibilities

The Expert Solid State & Non-Chromatographic Analytical Technologies is an individual contributor that will report to the QC Manager Analytical Excellence & Compliance.

Main responsibilities include:

• Maintain daily contact with the supervisors of non-chromatographic release and IPC labs to ensure optimal support for testing laboratories.

• Drive complex scientific / quality investigations in your field in a cross-functional team and facilitate related remediation plans (e.g., CAPA plan).

• Liaise with relevant partner organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts to support troubleshooting.

• Drive systematic changes in Geel QC non-chromatographic area, create and assess change controls, facilitate implementation plan.

• Independently prepare, finalize, and/or review GMP procedures applicable to non-chromatographic laboratories of Geel QC.

• Develop fit-for-purpose standards and guidelines applicable to the QC analytical laboratory to achieve both scientific excellence and regulatory compliance in a commercial QC environment where New Product Introduction is in strategic focus.

• Drive the local implementation of best practices in the non-chromatographic area by having fit-for-purpose guidelines in place and by creating classroom / hands-on training opportunities.

• Ensure scientific coaching of laboratory staff on technical and scientific matters in your field.

• Monitor local practices in the lab, challenge status quo and ensure continuous improvement in alignment with latest industry trends, regulatory expectations and global J&J practices.

• Participate in global and local working groups to facilitate the implementation of state-of-art methodologies in your field (e.g., PAT, RTRT).

• Promote quality awareness and proper adherence to GMP.

• Provide support regarding equipment deviations and coordinate with the equipment management group for supplier contacts.

• Explore, evaluate, and introduce new equipment and new analytical technologies in your field to ensure the laboratory evolves with increasing quality requirements and standards, while maintaining personal scientific expertise.

• Drive and represent Geel QC in analytical lifecycle management initiatives for the legacy portfolio.

• Drive analytical method transfer activities for non-chromatographic methods to and from Geel QC laboratories.

• Act as system owner for an extensive laboratory instrument park. As system owner, verify that all training requirements are met before granting users access to equipment.

• Maintain GMP standards to ensure continuous compliance with current requirements.

• Participate in global compendial vigilance & compliance process by review compendial updates for “General Chapters” of EP, USP, JP, ChP, IP, and BP and by facilitating their fit-for-purpose local implementation.

• Ensure inspection readiness of non-chromatographic laboratories of Geel QC and act as spokesperson during authority inspections.

how to succeed

Education: 

A minimum of a Master’s degree in Chemistry, Pharmaceutical Sciences or related scientific field is required. PhD is a preference.

Experience & Skills:

• Minimum of 5 years’ experience in small-molecule CMC analytical area (analytical R&D, MSaT, industrialization).

• Experience in late-stage development / small-molecule API industrialization.

• Experience in different phases of pharmaceutical development is an advantage.

• Up-to-date knowledge of pharmaceutical product release, stability testing, analytical method validation, analytical method transfer and compendial method verification as per current regulatory standards.

• In-depth understanding of cGMP principles and relevant regulatory guidelines in the analytical area, such as ICH Q1, Q2, Q3/A,C,D, Q7, Q14, M7 relevant USP and Ph. Eur. chapters.

• In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12.

• In-depth scientific familiarity with the typical non-chromatographic analytical technologies occurring in small-molecule API synthesis, such as solid-state techniques (e.g., particle size distribution by laser diffraction, XRPD), titrations (water determination by KF, potentiometric titrations), IR spectroscopy, UV spectroscopy, Raman, AAS, ICP-OES/MS.

• Familiarity with chemometrics, multivariate experimentation and modelling.

• Hands-on experience with PAT and RTRT is an advantage.

• Understanding of the principles of risk-based small-molecule process control strategy development, specification management (ICH Q6) and impurity management (ICH Q3 group of guidelines, ICH M7, latest regulatory standpoint on nitrosamines).

• Ability to work independently in a dynamic environment, handle multiple tasks, and collaborate effectively.

• Strong interpersonal and teamwork skills.

• Ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication, and presentation skills across all levels of the organization are important.

• Full professional proficiency in English and understanding of Dutch.

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months.

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 via LinkedIn messaging.

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”.