Gene Therapy Director of Production (m/f/d)

Who we are

Join us pioneering life changing Gene Therapies for the world.

With our focus on bringing transformative gene therapies from pre-clinical development into the market we aim to translate scientific progress into curative medicines for patients. Development of world class processes and analytical tools as well as manufacturing safe and sustainable medicines is our core business.

The position

As Gene Therapy Director of Production (m/f/d), you will join an agile and highly motivated organisation focussing on Technical Research & Development and Clinical Manufacturing of Gene Therapies. The objective of your work is to oversee manufacturing of ATMPS with a focus on recombinant viral vectors (AAVs) for in vivo Gene Therapies. As a key member of a global organisation you will collaborate with colleagues from different functions and sites of the Roche group.

Key responsibilities include, but are not limited to the following tasks

• Overseeing manufacturing of AAV based Gene Therapies and responsibilities as Director of Production (LH, Leitung der Herstellung) according to EU GMP guideline & German Drug Law (AMG and corresponding AMWHV) for AAV based Gene Therapies

• Responsibility for business process strategy and implementation of the respective digital backbone systems for manufacturing: e.g. SAP (S/4HANA, “ASPIRE”) and Manufacturing Execution System (MES, Rockwell Pharmasuite)

• Development and implementation of quality concepts for manufacturing operations via direct and matrix leadership as well as coordination with relevant quality partner units. Assuring compliance to such concepts of operational staff as well as defending such concepts during authority inspections

• Scientific Assessment and management approval of risk assessments, changes, deviations (planned events and critical unplanned events) as well as corrective and preventive actions (CAPAs)

Who you are

• You have 7+ years professional experience in manufacturing of biopharmaceuticals ideally according to EU GMP guideline & German Drug Law (AMG and corresponding AMWHV).

• You hold a major and ideally PhD in Chemistry, Biology, Biochemistry, Virology or related field with solid scientific understanding of biopharmaceuticals and/or viral vectors

• In-depth knowledge of ATMP and respective GMP guidelines is a major advantage

• Digital mindset and strong drive to shape the digital backbone of manufacturing operations

• You are a team player but also have the ability to work independently with excellent planning and organizational skills

• Pronounced strategic and entrepreneurial thinking

• Fluent English and German skills, written and spoken, are mandatory

This position is temporary and limited to 3 years.

Application documents

To make the application process as convenient as possible for you we are looking forward to receiving your application with an up-to-date CV. At the moment we do not need any further documents such as cover letters, certificates or similar.

Application period until at least 12 September 2023

(Application is possible as long as the position is posted)

We are looking forward to your application!

Do you need more support?

Our Talent Acquisition Team welcomes your questions. Please send an email to

germany.talent_acquisition@roche.com

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche at Penzberg, near Munich, employs more than 7,000 people. The site is one of the largest biotechnology centers in Europe and the only Roche site with research, development and production for both Pharmaceuticals and Diagnostics under one roof. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages and special family assistance programs are available.

Roche is an Equal Opportunity Employer.