Job Title
Mfg Ops Specialist - Clinical Therapies
About the Job
This is a(n) Associate Specialist position within the Manufacturing Operations group. The role requires full-time physical presence at the site to support manufacturing.
The successful candidate will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.
Main Responsibilities:
* Set up, practical execution and troubleshooting of upstream, downstream and support unit operations in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP).
* Management and documentation of process execution, deviations, changes and CAPAs.
* Involvement in continuous improvement efforts and support for the implementation of new technologies.
* Creation and updates of SOPs and master batch records.
* Material management using ERP systems (SAP).
* Mentoring and training of junior team members.
Requirements:
* Educational background in a relevant discipline.
* A minimum of 2-5 years of work experience in the pharmaceutical or biotech industry.
* Expert knowledge of some unit operations in upstream or downstream processing of biologics.
* Ability to solve problems and take new perspectives on existing solutions.
* Effective oral/written communication skills in English (C1).
* Oral/written communication skills in German (B1-B2).
Nice-to-Have:
* A bachelor's or master's degree in a relevant discipline.
* Experience with quality management and compliance systems.
* Familiarity with automated systems in manufacturing.