Analytical Project Leader

Posted 5 Hours Ago
Be an Early Applicant
Basel, Basel-Stadt, CHE
In-Office
Mid level
Healthtech • Biotech • Pharmaceutical
The Role
Lead and coordinate analytical development activities for small-molecule drug substances and products. Develop and validate ICH-compliant HPLC/UPLC methods, run stability and impurity studies, supervise internal and external lab work (CROs/CDMOs), prepare regulatory documentation (IND/NDA), and coach junior staff while ensuring cGMP and quality compliance.
Summary Generated by Built In

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The perfect candidate for this Analytical Project Leader role is a highly experienced chemist with a Ph.D. or Master’s degree and a minimum of three years in small molecule drug development. They must be an expert in HPLC/UPLC and ICH-compliant method validation, capable of independently managing stability studies, impurity profiling, and regulatory documentation (IND/NDA). Beyond technical prowess, they are a proactive leader who seamlessly coordinates between internal labs and external partners while maintaining a strict cGMP and quality-focused mindset.

The Opportunity:
  • 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.

Who you are:
  • 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

  • Fluent in English; German proficiency preferred

  • 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

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Skills Required

  • Master's or Ph.D. in chemistry, pharmacy, or related field
  • Minimum three years' professional experience in analytical development of small molecule drug substances or drug products
  • Expertise in High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC)
  • Proven experience developing and validating ICH-compliant analytical methods
  • Proficiency in degradation and stability studies, including forced degradation and impurity profiling
  • Experience working in cGMP environments and supervising internal laboratory activities or testing at CROs/CDMOs
  • Experience preparing regulatory submissions and documentation (IND/NDA)
  • In-depth knowledge of chemistry including synthesis, purification, and characterization
  • Fluent in English
  • German language proficiency
  • Digital savviness and familiarity with statistical analysis of analytical data
  • Ability to coach technicians and junior scientists and coordinate stakeholders and external partners
  • Strong quality mindset and excellent attention to detail

Roche Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.

  • Retirement Support U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
  • Leave & Time Off Breadth Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
  • Healthcare Strength Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.

Roche Insights

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The Company
Provincia de Buenos Aires
93,797 Employees
Year Founded: 1896

What We Do

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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