Formulation Scientist, Oral Dosage Forms / Labormitarbeiter Galenische Entwicklung (m/f/d)

The role: Position purpose

The purpose of this role is to develop our growing pipeline of oral products. We are looking for an expert in the area of Oral Solid Dosage Forms (small molecules, NCE). As a member of the team, you will play a key role in the development of formulations and processes for oral dosage forms with end-to-end scope, from first-in-human trials to marketing phase.

You will plan, perform and document scientific experiments for formulation- and process development for preparation and timely delivery of drug products incl. support at GMP manufacturing, primarily in the area of Oral Solid Dosage forms. You will participate in scientific teams and contribute to the overall Technical Research and Development strategies and goals.

Major accountabilities

For the development of oral solid dosage forms we are looking for an experienced associate. Your duties will be to develop formulations of capsules, film coated tablets or sachets, to develop manufacturing processes including scale-up. In addition, you will support the process transfer to GMP Pilot Plant and Novartis Technical Operations (TechOps) sites, and support the manufacture of clinical supplies under a GMP environment. Your responsibilities will be to plan, perform scientific experiments (or pilot plant processes) for formulation- and process development under minimal guidance from team members and to contribute to the interpretation and report results. You have experience in actively applying digital tools e.g. for reporting of experiments, and are experienced and curious to utilize and to further advance data&digital tools.

Your accountabilities will include:

• Plan, coordinate, perform and document scientific experiments in collaboration with functional and project leads
• Develop phase appropriate formulations for oral drug products
• Develop efficient and robust processes for oral drug products
• Utilize data digital tools (e.g. e-Lab Journal, digital IPC data handling, digital data recording, data visualization tools)
• Provide raw data documentation, evaluation and interpretation of results
• Propose and provide input for the design of next experiments
• Transfer procedures/instructions to GMP production facilities (e.g. Pilot Plant, NTO), including troubleshooting
• Support the manufacture of clinical supplies under a GMP environment
• Contribute to investment projects and maintenance of infrastructure/equipment.
• Adherence to quality, quantity, and timelines for all assigned tasks.
• Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
• Reproducibility of experiments and results.

Minimum Requirements:

Education:

Degree in Pharmaceutical Sciences or a related discipline (e.g. MSc, or BSc with > 2 years industry experience or a College of Applied Science Diploma or equivalent, lab technician Apprenticeship with > 6 years industry experience and relevant on the job training) with strong experience in formulation development and pre-formulation. Experience in manufacturing under GMP is advantageous.
 
Experience

1. Ideally a minimum of 3 to 5 successful years of experience in pharmaceutical development of oral solid dosage forms, e.g. in lab, technicum or Pilot Plant setting, with experience in the most common pharmaceutical technologies und unit operations. Experience in formulation development / pre-formulation incl related experience with (functional) excipients and on enabling formulations is advantageous.

2. Awareness/proven experience for safe handling of chemicals, potentially dangerous materials and equipment.

3. Experience and Severity in actively applying data-digital tools alike e-LabNotebook, digital documentation and data recording tools. Additional experience, e.g. from contribution to the development and advancement of those tools is advantageous.

4. Good scientific or technical knowledge in galenics/pharmaceutical technology / formulation- and/or process development at lab, pilot and production.

5. Excellent user experience of software and computer tools (e.g. electronic documentation).

Languages.

Proficiency in English required (oral & written), German and/or French is an advantage.

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

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.