The (Senior) Manager / (Senior) Principal Scientist, positioned in Manufacturing Science and Technology (MSAT), leads an internal team of scientists, is part of a multi-functional team supporting life cycle management activities, 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.

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

Together with their 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 and complete process optimizations / investigative work to support cost improvement projects.

Will take the lead in assigned investigations and coordinate activities with/for the assigned team members practical lab work in support of root cause analyses.

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.Competencies (knowledge, skills, abilities, and experience required):

• Several 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.
• Will be managing a team composed primarily of chemists.
• Already experienced in any combination of the following: material qualifications, supplier/process changes, investigations, validations (PPQ and CPV), audit & filing responses.
• Understanding of good manufacturing practice (GMP).

Holds a MSc, PhD or equivalent experience in chemistry, chemical engineering, or related field, with 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.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.