Overview

Process Manager Manufacturing Science & Technology (MSAT) – Late-Stage Processes, DSP (m/f/d)

The Process Manager will oversee the downstream processes of our customers‘ APIs throughout the complete product life cycle. This comprises the following key responsibilities which will be fulfilled in close collaboration with our Process Science and Manufacturing departments:
Design of robust, scalable, and economic downstream processes for a wide range of biopharmaceuticals in line with clinical and commercial timelines and overall business plans
Process scale-up and transfer within our internal network and to external manufacturing sites
Design of late-stage development activities and support of process characterization studies
Process qualification and validation at manufacturing scale
Definition of control strategies for commercial manufacturing
Setup and performance of continued process verification

These responsibilities will be assumed by actively carrying out and managing the following tasks:

Direct communication and representation towards customers in face-to-face meetings and conference calls
Interdisciplinary and cross-functional interaction with colleagues from associated departments
Troubleshooting and process optimization at manufacturing scale
Participation in deviations, out-of-specifications, and change management
Ownership and review of process descriptions, risk assessments, protocols, and reports
Ensuring compliance with international technological and regulatory standards
Review of relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
Participation in customer audits and authority inspections
Involvement in process optimization and innovation projects
Continuously striving for improvement and optimization in all areas of work

The successful candidate will have the following basic qualifications:

PhD or relevant experience in biotechnology, biochemistry, bioprocess engineering, or comparable scientific/technical field
Multiple years of experience in downstream processing using scalable technologies 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
Entrepreneurial mindset, economic and analytical thinking
Fluency in English

Preferred qualifications:

Expertise in biotechnological processes, with an emphasis on and experience with commercial products
Experience in process qualification/validation (PPQ)
Experience in continued process verification (CPV)
Know-how in statistical concepts and tools
Knowledge of upstream processing is a plus

We offer

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

WWW.RENTSCHLER-BIOPHARMA.COM

Rentschler Biopharma SE

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