As a contract company for the development and manufacturing of biopharmaceuticals, Rentschler makes an essential contribution to the worldwide availability of biopharmaceuticals. We are a strongly growing family-owned company employing approximately 850 employees. Last year Rentschler doubles its manufacturing capacity to address growing demand for biopharmaceuticals. To address this expansion we have to enlarge our team.
What unites us at Rentschler, is the passion for what we do. Every member of our team, with the knowledge and skills, is actively committed to the success of our projects. You can become a part of our team! We offer you an exciting work environment with excellent career development opportunities.
Process Manager Upstream Development (m/w/d)
As part of our group Process Science USP, we are seeking a Process Manager. The Process Manager will be in charge of the upstream/downstream processes of our customers’ APIs throughout the complete product lifecycle. This comprises the following key responsibilities:
Design and development of scalable upstream processes from bench to commercial scale for a wide range of biopharmaceuticals
Transfer of customer upstream processes to the Rentschler process format and alignment with the Rentschler standard process.
Design of late stage process optimization and process characterization / robustness studies by risk based strategies in preparation of process validation at manufacturing scale
These responsibilities will be assumed by actively carrying out and managing the following tasks:
Direct communication and representation towards our customers in “face-to-face meetings”, conference calls, etc.
Consulting our customers in subject matter-specific project strategy within the product lifecycle
Ensure compliance with international technological and regulatory standards
Responsible for compliance of timelines and milestones according to overall project plans
Technical supervision of lab technicians and engineers in USP development
Scientific advice for manufacturing science and technology team (scale up to internal and external production sites, deviations, changes, process validation)
Subject matter expert in an interdisciplinary and cross-functional team with colleagues from production, USP, quality control, QA/RA and Innovation
Compile and review protocols and reports in a timely manner
Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
Participate in customer audits and authority inspections
Participate in innovation and internal projects for driving progress of the group / company
PhD or relevant experience in biotechnology, biochemistry or comparable scientific/technical field
Several years of active experience in the field of USP development preferably using scalable technologies in context of industrial pharmaceutical manufacturing
Deep knowledge of cell metabolism, protein expression and bioreactor Technology
Significant knowledge in analytics methods and downstream processing
Fluent in German and English
Basic knowledge in project management
High level of initiative and excellent organizing ability
Entrepreneurial mindset, economic and analytical thinking
Strong and collaborative communication skills, team spirit, flexibility and outcome-oriented working
Willingness to work at weekends
Variod working environment in a future-proof industry
Flexible work time
Occupational Health Management and retirement provision