Process Manager Manufacturing Science & Technology – Commercial Manufacturing, DSP (m/f/d)

The Process Manager will oversee the commercial downstream processes of our client’s APIs. This comprises the following key responsibilities which will be fulfilled in close collaboration with our further MSAT groups, the Process Science and the Manufacturing department.
Setup and performance of Continued Process Verification (CPV) to assure constant control of our commercial manufacturing processes
Process optimization and coordination of revalidation activities at production scale
Ensuring compliance with international technology standards and authority requirements

These responsibilities will be met by active performance and management of the following tasks:
Direct communication and representation towards clients in conference calls and face-to-face meetings
Interdisciplinary and cross-functional interaction with colleagues from associated departments
Ownership and review of process descriptions, risk assessments, protocols, and reports
Participation in deviation, out-of-specification, and change management
Review of relevant chapters of CMC dossiers (BLA/MAA)
Preparation of and participation in customer audits and authority inspections
Support of process performance qualification (PPQ) and validation at manufacturing scale
Process scale-up and internal/external transfer
Active engagement in internal improvement and innovation projects

The successful candidate will have the following qualifications:
University degree in biotechnology, biochemistry, bioprocess engineering, or comparable scientific/technical field
Multiple years of experience in the context of biopharmaceutical manufacturing
Strong and motivating communication skills, team spirit, and flexibility
High level of initiative, personal responsibility, and excellent organizational skills
Good fluency in English

Preferred qualifications:
Practical knowledge of regulatory requirements
Experience in the management of commercial biopharmaceutical products
Expertise in biotechnological (downstream) processes
Statistical expertise and digital data management skills

We offer:
Employment that offers real value and work that manufactures medicines for critically ill patients
Contagious joy in the job as well as a collegial working environment
Access to exclusive, personalized training through the Global Rentschler Academy
Flexible working hours, flextime account and mobile working
30 days of holiday
Responsibility, initiative, further development
Company health management and pension scheme
Company child-care center
Future-proof industry

Rentschler Biopharma SE

Erwin-Rentschler-Str. 21 · 88471 Laupheim · www.rentschler-biopharma.com