At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

The Senior Principal Scientist, positioned in Drug Substance Manufacturing Science and Technology (MSAT), is part of a multi-functional team supporting activities related to the life cycle of active pharmaceutical ingredients, and is responsible to deliver the data/science at the base of every decision. Working in close collaboration with our partners within MSAT, R& D, manufacturing and quality, the candidate guarantees a smooth commercial manufacturing.

You will be responsible for taking a leadership role in life cycle projects and leading investigations in support of internal and external chemical production of commercial small molecule drug substances and intermediates, with the commercial organization as partner. You will be fully integrated in the Life Cycle Sciences team as part of MSAT SM DS, and collaborate with chemists, engineers (supply chain and R& D), analysts, and other experts.

Together with the team, they will support supplier qualifications, risk assessments and tech transfers, which includes the timely preparation of technical reports to ensure the continued high quality of our products, processes, and systems.

Will develop, lead, plan process optimizations to support cost improvement projects.

At times, also contributions to regulatory filings or responses to Health Authority questions may be required.

The candidate brings a significant level of statistical understanding and is knowledgeable in the use of statistical tools or is willing to learn them.

Qualifications:

• At least 10 years of experience in a related field (e. g. manufacturing environment, process development) with an interest in broadening personal scope. The role is a growth opportunity for chemists and engineers. Chemists should have the willingness to develop an engineering mentality and increase their understanding of process related topics. Engineers should have an interest in growing their chemistry knowledge and to work hands-on in a development lab.
• Keen interest in trouble shooting / root cause analysis and regulatory requirements.
• Good communication and documentation skills.
• Flexibility and ability to prioritize tasks.
• Excellent understanding of statistical methodologies, in order to work out lean statistic sample plans, DOE-plans and statistical evaluation of data outcome of experiments is a plus.
• Proactive mentality, ready to seek out and engage with various partners both globally and on-site.
• Already experienced in any combination of the following: process design, validations (PPQ and CPV), audit & filing responses, tech transfers, nitrosoamine risk assessments, impurity management, complex investigations.
• Understanding of good manufacturing practice (GMP).
  

Holds a PhD or equivalent experience in chemistry, chemical engineering, or related field, with a minimum of 10 years of professional experience in process development or chemical / pharmaceutical production.

Languages:

Proficient in written and spoken English.

Proficiency in Dutch is an asset.

Specific systems:

Knowledge on Minitab, R, python, or SAS is helpful.

Physical requirements/working conditions:

Main location: Beerse/Geel

Works in an international environment across different time zones.

Travel: This position might require up to 10 % (domestic and international) travel.

#LI-MV2
#LI-Hybrid