Pharmaceutical Expert Continuous Manufacturing

Job description

Job Description

The Continuous Manufacturing Unit within Novartis Pharma Development / Technical R&D aims to develop innovative continuous manufacturing technologies for solid oral forms (small molecules NCEs) in close partnership with academia and vendors and subsequently to utilize continuous Manufacturing Technologies within Development Projects.

Major Accountabilities:

1. Actively participates in project teams and networks as responsible to development formulations, processes, equipment, and control strategies for continuous manufacturing of solid dosage forms.
2. Actively supports the manufacturing of drug product for clinical supplies under full GMP using continuous manufacturing processes including documentation preparation and review, scientific support and handling of deviations and changes.
3. Identifies options for enhancement of continuous manufacturing capabilities and screening of the continuous manufacturing landscape within the pharmaceutical industry.
4. Ensures quality, quantity and timelines in all assigned projects, networks and/or platforms and coaches associates on target dates and priorities;
6. Evaluates data, interprets results, , draws relevant conclusions, writes reports and actively drives any required implementation;
7. Generates and selects most appropriate scientific documents that are handed over to internal and/or external partners, such as Technical Operations, authorities, or other companies;
8. Proactively supports the generation of international registration documents and interacts with authorities where appropriate;
9. Proactively participates in budget forecasts, prepares and tracks invoices and ensures cost awareness in all assigned projects and/or networks;
10. Interacts and collaborates with other functions in Development to facilitate the transfer of knowledge of continuous manufacturing for drug products
11. Actively supports the continuous manufacturing unit as a technical expert on audits and inspections;

This position may require up to 15% travel.

Desired profile

Minimum requirements

Education:
- Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent) is desirable

Language:
- Good knowledge of English
- Knowledge of the site language German is desirable

Professional Experience:
- Min. three years of successfully demonstrated directly related experience in drug product development or manufacturing process development in pharmaceutical industry
- Proven track record in the development of innovative solutions for drug product manufacturing, e.g. equipment design, formulation or control strategies (PAT).
- Thorough knowledge of state-of-art instrumentation/equipment for solid oral dosage manufacturing, preferable in continuous manufacturing
- Thorough understanding of development processes in pharmaceutical industry; advanced experiences in continuous manufacturing is desirable
- Profound literature search skills
- Ability to work in and/or lead interdisciplinary and/or cross-cultural teams
- Strong knowledge of relevant regulatory and GxP guidance’s for drug product development and manufacturing. Knowledge of guidance’s related to continuous manufacturing specifically is an advantage
- Strong communication, presentation and scientific/technical writing skills
- Advanced coaching skills