Analytical Project Leader

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Background:

The Analytical Research & Development department, an integral component of Synthetic Molecules Technical Development, bears global responsibility for the advancement of cutting-edge analytical methodologies, the comprehensive analysis of raw materials, intermediates, active pharmaceutical ingredients, and diverse dosage forms pertaining to synthetic molecule development products, and the meticulous preparation of regulatory documentation for submission to health authorities.

In this role you will be joining a highly motivated and experienced team of analytical scientists. You will be responsible for leading analytical development activities for synthetic molecule projects, from early development to commercialization. This is an exciting opportunity to apply your expertise in a dynamic and challenging environment, contributing to the development of life-changing medicines.

Tasks & Responsibilities :

• Developing a phase-appropriate control strategy for drug substances and drug products.
• Collaborating effectively with stakeholders across various departments.
• Coordinating comprehensive analytical activities, which involves generating physical and chemical data for materials, developing/improving and validating analytical test methods or other analytical controls and ensuring thorough documentation, timely delivery and adherence to quality standards.
• Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information.
• Conduct work in compliance with cGMP where applicable, safety, and regulatory requirements.
• Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs.
• Plan and document experiments/results independently and prepare for regulatory submissions such as IND and NDA.

Must Haves:

• A Master's or Ph.D. in chemistry, pharmacy, or a related field.
• At least 3 years of professional experience (industry-based) in analytical development of drug substances and products for peptides.
• In-depth knowledge of peptide chemistry, including synthesis, purification, and characterization.
• Expertise in key analytical techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC) and Mass Spectrometry (MS) for peptide analysis.
• Proven experience in developing and validating ICH-compliant analytical methods.
• Proficiency in degradation and stability studies for peptide, including forced degradation and impurity profiling.
• Understanding of key requirements for peptide drug substances and/or drug product specifications.
• Strong knowledge of peptide degradation pathways.
• A strong quality mindset and excellent attention to detail.
• Digital savvyness to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous.
• Open-minded, goal-oriented, and able to work in a fast-developing environment.
• Takes challenges as opportunities and is able to respectfully collaborate with team members, customers and stakeholders, even in stressful situations.
• Excellent command of the English language.

Nice to Have:

• Additional experience in analytical development with oligonucleotides or biologically derived molecules is a plus.
• Proficiency in German is considered a plus.
  Extended skills for liquid formulations are considered as a plus:
• Understanding of the physicochemical properties of peptides and how they impact formulation development.
• Skilled in conducting systematic stability studies for peptides in liquid formulations under various conditions.

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining
• Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Marianne Buser.

Basel-Stadt Research Peptide Analytical Development HPLC UPLC ICH Compliant Method Pharmaceutical R&D cGMP Validation