Expert Analytical CMC

Expert Analytical CMC

Location: Geel

Working mode: Hybrid

Duration: 12 months

Hours: Full-time, 40 hours per week

Imagine your next project driving improvement initiatives to enhance the efficiency, agility, scientific standard and regulatory compliance level of QC Geel, and through this enhancing commercialization of SM-API and DP Intermediates and maintaining the analytical CMC package of legacy portfolio at a state-of-art level.

position description

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.

The Contractor – Expert Analytical CMC is an individual contributor who will work with QC Manager Analytical Excellence & Compliance. 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.

roles and responsibilities.

• 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.

• Ensure frequent communication and establish partnership and engagement with operational QC lab team to implement changes in an efficient and desired manner.

how to succeed

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

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

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

• 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 ICH 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.

• Scientific familiarity with the typical analytical technologies occurring in small-molecule API synthesis, such as liquid chromatography, gas chromatography, titrations, solid-state techniques, and mass spectrometry.

• 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. Understanding of Dutch is an advantage.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 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 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”.