Analytical Project Leader (m/f/d)

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, 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.

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 Haves

• 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

Benefits

• Work with modern and up-to-date tools in an innovative work environment.
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
• Benefit from financial support for your professional development plans.
• 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.
• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare.
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere.
• Take advantage of attractive fitness and swimming pool facilities or the gaming room as a creative retreat.
• 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, provided you meet the relevant qualifications.
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days.

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

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Kontakt
Adnan Ferizi

Arbeitsort
Basel

Pensum
100%

Position
Mitarbeiter

Branche
Pharma + Chemie + Life Science