Senior Scientist MSAT Synthetics DS

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Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Beerse, Antwerp, Belgium
Job Description:

The Senior 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 based in the small molecule drug substance labs as part of Manufacturing Science and Technology (MSAT). Supporting a multi-functional team in developing and deliver solutions required to maintain continued supply of Johnson and Johnson innovative medicines.

You primarily support the Life Cycle Science team by performing lab-based activities.

Together with the rest of the team, you 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.

You will:

• develop, plan, lead and complete lab-based activities, mimicking full scale process performance, performing root cause analysis experiments, use-tests, or reprocess testing/development).

• transfer sophisticated processes, manufacturing technologies, analytical technologies to multiple sites and other laboratories.

• evaluate process and process analytical technology (PAT) data to define experimental activities to understand and resolve manufacturing issues.

• Lead or support process capability and quality improvement efforts on new or marketed products.

• Provide advanced expertise to assist in the implementation of technical transfers at internal and external manufacturing sites based on lab results and reduced scale process models.

**Qualifcations:
**

PhD or MSc or equivalent experience related to pharmaceutical manufacturing or a Bachelor's degree and extensive lab and manufacturing experience in process development or chemical / pharmaceutical production.

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.

Candidates should have excellent laboratory skills and research experience, with emphasis on:

• Experience with organic chemistry, chemical process development

• Use of electronic lab notebook systems and instrument logbooks

• Analysis and interpretation of data

• Experience with analytical tools (U/HPLC, GC, NMR)

• Experience with process analytical technologies (PAT) like FTIR, FBRM, Raman Spectroscopy would be highly desired.

• Experience with operational responsibilities of a laboratory, including purchasing materials, equipment set up/operation, management of chemicals, which may include controlled substances.

• Technical writing for the generation of technical reports

• experience with document control systems and change control systems is helpful or the willingness to learn

• Basic understanding of statistical methods and statistical process control.

• Understanding of good manufacturing practice (GMP).

• Ability to seek out and engage with various partners both globally and on-site.

• Laboratory safety practices and response procedures,

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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