Analytical Project Leader Senior / Principal Scientist

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At Roche, our focus is on addressing urgent medical needs and developing innovations for the future. We are deeply committed to improving patients' lives and believe that strong business practices lead to a better world. Our commitment lies in scientific rigor, unwavering ethics, and ensuring access to medical innovation for everyone. We are dedicated to building a better future through our work today.

This position is within Analytical Development Synthetic Molecules (PTDC-A), part of Pharma Technical Development. We are responsible for developing state-of-the art analytical solutions to meet the needs of early-stage, late-stage, and commercial products. Our goal is to establish robust control strategies for manufacturing and releasing of drug substances (DS), drug products (DP) for future market applications.

As an Analytical Project Leader, you will be responsible for all analytical aspects of projects throughout the development lifecycle. You will work closely with peers, lab technicians, and cross-functional partners from areas such as process development, material sciences, manufacturing, regulatory affairs, and quality assurance. 

• Cover all analytical aspects during the technical development lifecycle of synthetic peptides. Drive the elaboration of the analytical control strategy in close collaboration with cross functional partners

• Represents Analytical Development as an Analytical Project Lead in the cross functional Technical Development Team.

• Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs. 

• Develop, establish and validate testing methodologies for raw materials, production intermediates, and final products (API and DP) at all stages of process development.

• Conduct work in compliance with cGMP where applicable, safety, and regulatory requirements.

• Plan and document experiments/results independently and prepare for regulatory submissions such as IND and NDA.

We are seeking a highly skilled and experienced Analytical Chemist with a specialization in peptide analysis. The ideal candidate will possess:

• A Master's or Ph.D. in chemistry, pharmacy, or related field with min. 5 years  of professional experience in the pharmaceutical industry.

• Strong expertise in peptides analytical development including liquid formulation development support and implementing a control strategy for impurities in IND and  NDA filings.

• A strong foundation in liquid chromatography (HPLC and UHPLC) with various detection methods like UV, MS, fluorescence, and charged aerosol detection. Should be familiar with different column chemistries and method development strategies for peptide separation and analysis. Experience in peptide mapping by mass spectroscopy (MS), amino acid analysis (AA) is advised. 

• Familiar with process development for peptides and related impurities from SPPS & LPPS processes

• Strong expertise in techniques for characterizing peptide aggregation and liquid formulation development such size-exclusion chromatography with multi-angle light scattering (SEC-MALS), analytical ultracentrifugation (AUC), circular dichroism (CD), ion-exchange chromatography (IC), know-how about imaging techniques for particles characterization (e.g. MFI, NTA) and about zeta potential und B22 determination would also be a significant asset.

• Experience with method validation according to ICH guidelines and a strong understanding of quality control principles are necessary. Familiarity with statistical analysis of analytical data would also be beneficial.

• Experience in applying GMP requirements and understanding their application in different clinical phases.

• Knowledge about GMP release testing for microbiology, endotoxin and sterility

• Experience in device development support is a plus

- A strong quality mindset and excellent attention to detail.

- Digital savvyness to support digital transformation initiatives.

- 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.

- Additional experience in analytical development with oligonucleotides or biologically derived molecules is a plus

Have we triggered your interest?

Apply now! Please submit your CV, cover letter, and relevant diplomas and certificates.

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.