Pharmaceutical Process Engineer

Job description

Job Description

Within this position in a highly innovative environment within Novartis Pharma Technical R&D you - in your role as Pharmaceutical Process Engineer - are the functional expert to develop pharmaceutical processes internally as well as in collaboration with external partners. You will develop and build up corresponding pharmaceutical process engineering know-how for novel technologies, and utilize these technologies in development projects.
In this role you will also design, plan, perform, interpret and report results of scientific formulation experiments for the preparation and timely delivery of oral drug products incl. GMP manufacturing.; lead and manage all formulation activities, support & coach team members, participate in scientific teams and contribute to the overall Technical Research and Development strategies and goals.

To develop our growing pipeline of products we are looking for an experienced professional in the area of pharmaceutical development. In this challenging position, you'll play a key role in the development of oral dosage forms (esp. capsule based drug product) and the transfer to production. As member of scientific teams within TRD you will insure that high quality products are developed applying state of the art technologies, risk analysis and QbD methodologies. You will closely collaborate with particle engineering to build up in depth understanding on the impact of physical drug substance properties on the drug product process. We'll rely on you to achieve robust processes through optimization, scale-up and validation work and provision of the required documentation to allow worldwide registration. You will be working in multidisciplinary network organization and international teams and representing Pharmaceutical Development in external collaborations, which results in a wide range of scientific and strategic tasks. In this environment, facilitation, coaching and coordination skills are key to achieve sustainable performance. The development of new processing technologies and supervision of scientific projects are further options within this position.

In this position you will:
- Actively participate in teams, projects, networks and/or platforms.
- Fulfill all related tasks and responsibilities related to own discipline.
- Design, plan, perform and monitor all assigned activities (e.g. physical material characterization, capsule filling process development).
- Drive innovations in the area of Pharmaceutical Process-Engineering at the interface to innovative Equipment Engineering.
- Meet quality, quantity and timelines in all assigned projects, networks and/or platforms.
- Actively participate in budget forecast, grant preparation and tracking of invoices.
- Demonstrate cost awareness in all assigned projects and/or networks.
- Advise team members and work according to appropriate SOP’s, GLP, GMP, OQM, HSE, ISEC and Novartis guidelines.
- Interpret results, evaluate data, draw relevant conclusions, write reports. - Contribute to risk analyses and/or peer review and process challenge meetings.
- Generate scientific documents to hand over to internal and/or external partners (TechOps, authorities, external companies) actively support generation of international registration documents.
- Interact with authorities where appropriate.

Desired profile

Minimum requirements

Education:
Master or advanced degree (desired: Ph.D. or equivalent) with focus on pharmaceutical sciences and technology (e.g. Pharmacy, Pharmaceutical Technology, Chemical Engineering, Chemistry).

Language:
We expect a candidate to communicate fluently in English. German and/or French desired.

Professional Experience:
- Minimum 3+ years of successful industry experience in the development of pharmaceutical formulations (ideally oral dosage forms, solid understanding of QbD and biopharmaceutics).
- Excellent knowledge of laboratory and/or technical tools (in industrial setting) in the area of capsule filling (preferably with dosator-, tamping pin- and drum- filling technology) and broader scientific as well as strategic background.
- Proficient in utilization of special tools/equipment, lab automation tools and specialized tools
- Deep understanding on physical material properties, their adequate characterization and impact of material properties on pharmaceutical process performance.
- Strong understanding at the interface between Drug Substance and Drug Product.
- Good knowledge of software and computer tools. Profound literature search skills. Ability to work in and/or lead teams. Strong leadership skills. Strong knowledge of relevant SOP, GLP, GMP. Very good communication skills