Analytical Project Leader (Small Molecules) (m/f/d)

Beschreibung

As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Basel, we are currently looking for a motivated and dedicated Analytical Project Leader for a temporary assignment of 12 months.

The Analytical Research & Development department is a key part of Synthetic Molecules Technical Development. It is globally responsible for advancing analytical methodologies, performing in-depth analyses of active pharmaceutical ingredients, and diverse dosage forms, as well as preparing detailed regulatory documentation for submission to health authorities.

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, mely 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 formation
• 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, with at least three years of professional experience in analytical development of drug substances or drug products for small molecules
• In-depth knowledge of chemistry, including synthesis, purification, and characterization
• Expertise in key analytical techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC)
• Proven experience in developing and validating ICH-compliant analytical methods
• Proficiency in degradation and stability studies for small molecules, including forced degradation and impurity profiling
• Understanding of key requirements for drug substances and drug product specifications
• Excellent command of the English language
• A strong quality mindset and excellent attention to detail
• Digital savviness 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

   

Nice to haves

• Proficiency in German

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card

Are you interested? Do not hesitate and submit your complete application documents online today. We look forward to hearing from you!