Language

Expert - Technical Development

RNA
Biopharmaceutical
Batch Records
Drug Manufacturing
Chemistry
Lyophilization
Thermal Analysis
Aseptic
Manufacturing Processes
Manufacturing Process
GMP
Parenteral Formulation
Process Development
Oligonuccleotide
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.

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

Job Description Summary
Join our team in Pharmaceutical & Analytical Development (PHAD) and be a part of cutting-edge parenteral drug product development. Contribute to the advancement of novel technology platforms such as Oligonucleotides and Radioligand Therapies (RLT), and work on the Novartis main Campus in Basel. This is your chance to make a significant impact in the biopharmaceutical field and be at the forefront of bringing life-changing medicines to patients worldwide. The PHAD specialty Unit is seeking an experienced Formulation Drug Product Project Leader (FPL) to lead drug product formulation and manufacturing process development. Apply now and be a part of a team that is revolutionizing drug product development.

Major accountabilities:
• Be accountable for all formulation and manufacturing process deliverables including scientific documentation, design of experiments of parenteral products, batch records, deviations, change controls, CAPAs, tech transfer, and reports.
• Drive DP development, manufacturing process transfers and supply activities with scientific and technological excellence
• Work closely with cross functional teams both internal and external to provide technical input for the development and manufacturing process (including CRO and CMOs).
• Provide technical support to compile technical regulatory documentation and responses to regulatory agencies as needed.
• Assist with writing and reviewing of CMC documentation associated with project or manufacturing changes.

Key Skills:
• Formulation Expertise: Experience developing injectable drugs, including solutions, suspensions, and aseptic formulations. Knowledge of RNA-based therapies (e.g., siRNA, mRNA) and drug delivery systems like pre-filled syringes or vials.
• Process Development: Skills in designing manufacturing processes and transferring them to production environments. Familiarity with aseptic drug manufacturing and methods like QbD.
• Lyophilization Development: Experience in developing, optimizing and transferring freeze-dried products, including thermal analysis (DSC, FDM, XPRD), thorough understanding of cycle design and development (including model-assisted approaches), and scale-up from lab to pilot/commercial scale.
• Regulatory Knowledge: Understanding of GMP and preparing technical documentation for regulatory submissions.
• Analytical Thinking: Designing experiments (e.g., DoE) and analyzing data to improve formulations and manufacturing processes.
• Collaboration & Communication: Strong teamwork skills for working with internal teams and external partners (e.g., CROs/CMOs). Clear communication and ability to write reports, technical documents, and regulatory responses.
• Problem-Solving: Ability to handle deviations, implement corrective actions, and improve manufacturing processes.
• Innovation: Interest in advancing RNA drug delivery platforms and contributing new ideas to the field.
• Working knowledge of oligonucleotide-based therapies (e.g., ADCs, proteins, RNA-based drugs).
• Familiarity with process development for clinical-grade parenteral drug products. Proven experience in related fields such as pharmaceuticals, biotechnological product development, and advanced drug delivery platforms.

Required Qualifications:
• Ph.D., Master’s or Bachelor’s Degree in Chemistry or related disciplines: With 2+ years (Ph.D.), 5+ years (Master’s), or 8+ years (Bachelor’s) biopharmaceutical experience.
• Proven expertise in formulation and manufacturing process development for parenteral and aseptic products, including lyophilized dosage forms. Demonstrated capability in lyo cycle development and optimization.
•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.

Workload: 100% (40 hours per week)
Role type: Onsite
Required start date: December 2025
Contract: 12 months

Why Novartis: 
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 : N/A
  • Preferred years of experience : 3+ Years
  • Travel Required : No travel required
  • Shift timings: 9 AM to 5 PM
Job Location Basel, Basel-Stadt
Contract Duration 12 month(s)