Language

Senior Expert Science & Technology – Functional Lead

CMC
Data Analysis
Data Integrity
Filtration
GLP
Lyophilization
MS Office
Packaging
Product Development
Product Formulation
Description:

This is a temporary contractor opportunity at Novartis

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...

This is a Maternity/Paternity cover role. As Functional Lead (external) you will play a key role in the development of formulations and processes for parenteral dosage forms of Biologics (e.g. therapeutic proteins, conjugates and other new modalities) for clinical or commercial use.

You will be working in an international team at our headquarters in Basel, Switzerland and help to bring innovative treatments to patients and global markets around the word. The team is focused on pharmaceutical development of stable liquid and lyophilisate formulations as well as robust manufacturing processes of syringes, cartridges, vials and other presentations including the characterization of formulations.

Your responsibilities:
As Functional Lead, you will support one or several multifunctional project teams in the Drug Product Development unit within Novartis Biologics. Your responsibilities will be to:

  • Independently design, plan, organize and perform scientific experiments for the preparation and timely delivery of biologic drug products (DP), processes and procedures.
  • Independently design, plan, organize and perform specific analytical tests related to the experiments as well as for related stability studies.
  • Documentation of raw data from the scientific experiments including all conducted analytical tests as well as evaluation. interpretation and reporting of all results of the scientific experiments together with the project responsible (Functional Lead).
  • Interprets results including drawing relevant conclusions and delivers respective work packages to meet agreed objectives & timelines in the project team. Ensures and drives information exchange in DP sub-team.
  • You will be a core member of the Drug Product development sub-team, representing the scientific and technical excellence and you might be a member of the CMC team ad-hoc if required.
  • Based on the project status, participate in function-specific project sub team meetings and discussions
  • If required, support the compilation of scientific protocols / reports and lab procedures based on existing templates as well as contribute to compilation of SOPs
  • Take over responsibility for specific tools / equipment and utilize special tools / equipment or specialized facilities as an expert. Schedule and perform maintenance and qualification of tools / instruments / equipment as needed.
  • Develop new methods or optimize existing laboratory methods/processes as well as contribute to development and implementation of new technologies.
  • Where applicable take on roles and responsibilities related to operational excellence and/or innovation.
  • Work according to appropriate laboratory standards for quality, ethics, health, safety, environment protection, and information security. Support and participate in initiatives to ensure continuous improvement.
  • Use professional concepts, company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways. Proactively identify conflict situations and contribute to solutions.
  • Actively foster knowledge exchange and contribute to the team objectives.

What you’ll bring to the role:

  • PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent.
  • 1-3 years of successful experience in biotech / pharma industry with emphasis on biologics drug product formulation and process development, manufacturing, scale-up, and technology transfer
  • Experience in protein analytics, lyophilization, primary packaging development for biologics.
  • Experiences in BLA / MAA submission is an advantage
  • Hands-on experience in drug product formulation development and analytics for biologics including control for each unit operation, including mixing, filtration, and fill finish, experiences in lyophilization and primary packaging development for biologics is an advantage.
  • Proficient in English – spoken and written. Basic or proficient knowledge in German as local language is an advantage.
  • Strong skill in MS Office tools (Word, Excel, PowerPoint, TEAMS) as well as Data & Digital savviness
  • Highly structured and organized working style. Proven track record for working independently in development laboratory environment including basic knowledge on GLP and HSE requirements for development laboratories. Good understanding of data integrity requirements in development environment.
  • Good written and verbal communication skills.
  • Basic understanding of statistical data analysis and skills in data presentation is an advantage.

Workload: 40 hours/week
Role type: Onsite

Why Novartis:  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accommodation: If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com

QUALIFICATION/ LICENSURE :
  • Work Authorization : Other valid work visa
  • Preferred years of experience : 3+ Years
  • Travel Required : No travel required
  • Shift timings: 9 AM to 5 PM
Job Location Basel, Basel-Stadt
Pay CHF 50.00 - CHF 68.00 Per Hour
CONTRACT DURATION 12 month(s)