Experienced Process Chemist / Engineer
Janssen Pharmaceutica behoort samen met de andere bedrijven op onze campus tot de wereldwijde groep Janssen, die deel uitmaakt van de Johnson Johnson-groep. We ontwikkelen geneesmiddelen voor patiënten, artsen en andere zorgverstrekkers.
Experienced Process Chemist / Engineer - Project Leader
Pharmaceutical Development Manufacturing Sciences, the CMC organisation within Janssen Pharmaceutica N.V., is employing several hundreds of scientific researchers and specialized technicians at its site in Beerse, Belgium. API Small Molecule Development department is responsible for the development of processes for the supply of large quantities of new chemical entities that are needed for RD and commercial purposes. Moreover, new chemical processes are developed according to customer requirements concerning safety, environment, technology, economy and quality. We also are responsible for adequate information about those processes to guarantee successful registration of new medicines.
In the department of API Small Molecule Development we currently have a vacancy for (m/f):
Main responsibilities :
- As project leader or technical integrator you are, together with the chemistry lead, accountable for all API related project deliverables, including timely delivery of batches, required quality and acceptable API characteristics. You propose and follow-up on API Development timelines and plans.
- As project leader or technical integrator lead a cross-functional API team consisting of members of process RD, pilot plant, chemical process control and safety testing lab.
- Interacts with various stakeholders outside the department, such as Discovery, Purchasing and Commercial API manufacturing as well as external partners.
- Represents API Small Molecule Development on CMC teams and interacts with other departments such as analytical and drug product development.
- Ensures all filing and regulatory information is available and correct; represents functional area in meetings with authorities. Is responsible for API control strategy, including spec setting, IPC's, criticality analysis, process parameters.
- Reports and recommends to API Small Molecule Development management, when necessary, on project status, resources, budget, and issues.
- Leads the team on COGs, manufacturability (robustness), environment and safety evaluations.
- Responsible for transfer of processes to chemical manufacturing sites or external partners and ensures process transferability.
- Responsible for post-approval support of the project.
- API Small Molecule Development representative for pre and post-approval health authority, mock and customer inspections.
- You have a PhD in chemistry, preferable organic synthesis or a degree in Chemical Engineering
- More than 10 years of experience in pharmaceutical industry
Skills and Competencies
- You are capable of building and leading a team that gets things done
- You have a keen interest in recent developments of organic chemistry and related chemical technologies
- You like to work in a lab and plant environment
- You have excellent social and communication skills
Kijk ook op www.careers.jnj.com