Group Head in Analytical Development & Quality Control (80-100) Contract for 2 years

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

Pharma Technical Development brings game-changing therapies from clinical phase I into the market to serve every patient every day. Our core business is to develop safe innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product) clinical supply analytics formulation device and packaging. Our daily work includes authoring of regulatory documents and the transfer of development projects to the commercial organization.

We are striving for a caring and sensing network organization which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise passion and getting it done mentality. The benefit for the patient is in the center of our thoughts and efforts.

The department Analytical Development and Quality Control (ADQC) Biotech is responsible for Biochemical and Biophysical Analytical Development Quality Control and Compliance for Biopharmaceuticals Drug Products from pre Investigational New Drug (IND) to New Drug Application (NDA) and Launch.

The Opportunity

• Serve as analytical project lead representing ADQC in global technical development teams including the coordination of all necessary analytical activities for biotechnological development products

• Direct leadership responsibility for a team of approx. 6 associates / scientists incl. piroritization of workload

• Setting of specifications and shelf life for investigational medicinal products and support of IND and BLA (Biologics License Application) filings

• Evaluation implementation and further development of new technologies/ test methods to ensure state of the art analytics including analytical method validation and transfer

• Quality control for investigational medicinal products and batches used in preclinical and clinical studies

• Creation of prerequisites for securing a competent efficient GxP conform analytics in due time and keeping the current GxP guidelines as well as the relevant SOPs

Who you are

You are someone who wants to influence your own development. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are but the starting point. Additionally to that we are looking for the following qualifications and experience:

• PhD in Analytics Biochemistry Pharmacy or similar scientific qualification and a minimum of 3-5 years experience in biopharmaceutical industry with focus on protein analytics and characterization preferably in a GMP environment. Experience with combination products is a plus.

• Experience in development of new technologies and methods for biophysical/biochemical analysis and characterization of proteins

• Excellent leadership skills and a track record in cross functional collaboration. Ability to influence stakeholders at all levels will be essential in this role

• Self-motivated pro-active responsible result-oriented and an excellent team player with success in building trustful relationships

• Statistics expertise (e.g. statistical models and their application) and high affinity to digitalization is preferred

This is initially a 2 year contract.

If you are an experienced scientist looking to make an impact in a cross functional setting we would love to hear from you. Please apply by submitting your updated CV and cover letter via our careers portal.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.