At Roche, we believe it is urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives, and we are fearless in both decision and action. And we believe that good business means a better world.
That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
Who we are:
Preclinical Chemistry, Manufacturing and Controls (pCMC) is a global function within Pharma Research and Early Development (pRED). We develop robust and innovative API synthesis and drug products to supply and enable key preclinical activities paving the way towards Entry into Human. In addition, we are responsible for clinical phase I API supply of oligonucleotides and peptides programs. We are CMC specialists and together with our discovery functions partners, we generate scientific and technical knowledge to assess the developability of drug candidates. We build our strength on a broad diversity of enthusiastic technical specialists, pharmacists, chemists and analytical chemists delivering and innovating in the space of small molecules, peptides and oligonucleotides.
Your role:
As the GMP & Compliance Officer, you will own the overall pCMC GMP strategy and will be responsible for ensuring pCMC compliance with regards to GMP.
Your key responsibilities are:
Ensure compliance of small molecules supply for human mass balance and imaging studies with regulatory and GMP requirements
Ensure compliance of peptides and oligonucleotides clinical Phase I manufacturing with regulatory and GMP requirements
Ensure compliance of analytical work with regulatory and GMP requirements
Drive optimization, standardization and harmonization of the existing SOP landscape and GMP related processes, in alignment with key stakeholders
Manage and improve a harmonized training concept for pCMC
Represent GMP related topics during health authority inspections and internal audits
If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients’ lives. If you want work in a hardworking team, make your mark & improve lives, apply now.
Who you are:
You bring the following qualifications:
Master or equivalent and/or higher degree in chemistry or pharmaceutical sciences and at least 5 years operational experience in a GMP environment (manufacturing and/or development) within the pharmaceutical/biopharmaceutical business environment
Strong technical background and proven understanding of regulatory and health authority requirements in the field of GMP.
Strong cross-functional teaming skills: you have an inclusive and collaborative way of interacting. You demonstrate good interpersonal skills that enable you to effectively collaborate within a multidisciplinary and flat hierarchy environment and across different interfaces (technical functions, Regulatory, Quality Assurance, …).
Good verbal and written communication skills in German and English.
What we stand for?
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
If you still have questions then please check our FAQs and videos on careers.roche.ch/faq.
Roche is an equal opportunity employer.
Quality, Quality > Quality Systems