Senior Principal Scientist, Synthetics Drug Substance Manufacturing Science and Technology
il y a 1 jour
**Job Function**:
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function**:
Chemical Research
**Job Category**:
Scientific/Technology
**All Job Posting Locations**:
Beerse, Antwerp, Belgium
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.
**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.
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