PhD Biotechnology, Biochemistry as Process Manager DSP - Downstream Processing (m/f/d)

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 DSP (m/f/d)

As part of our group DSP Design and Validation, we are seeking a Process Manager DSP. The Process manager will be in charge of the downstream processes of our customers’ APIs throughout the complete product life cycle.

This comprises the following key responsibilities:

Job Description

  • Design and development of scalable downstream processes for a wide range of biopharmaceuticals
  • Scale up and transfer to our internal and external manufacturing sites
  • Process characterization in preparation of process qualification and validation at manufacturing scale
  • Continued process verification and optimization during commercial Phase
These responsibilities will be assumed by actively carrying out and managing the following tasks:
  • Direct customer contact in teleconferences and face-to-face meetings
  • Technical supervision of technicians and engineers in DSP development
  • Design and development of downstream processes from bench to commercial scale in line with clinical development timelines and overall business plans
  • Development and management of risk based strategies for process characterization (small scale) and qualification/validation (commercial scale)
  • Manage process deviations at manufacturing scale
  • Troubleshooting and late stage process optimization
  • Interdisciplinary and cross-functional interaction with colleagues from production, USP, quality control, QA/RA and science and technology
  • Compile and review protocols and reports in a timely manner
  • Review relevant chapters of CMC dossiers
  • Participate in customer audits and authority inspections

Requirements

The successful candidate will have the following basic qualifications:
  • PhD or relevant experience in biotechnology, biochemistry or comparable scientific/technical field 
  • Several years of active experience in the field of DSP-process development preferably using scalable technologies in context of pharmaceutical manufacturing
  • Strong and motivating communication skills, team spirit and flexibility
  • Fluent in German and English
Preferred Qualifications:
  • Experience in the process scale up and transfer from bench to production scale
  • Significant knowledge in protein analytics 
  • Experience in working in an industrial GMP environment
  • Expertise in process qualification/validation (PPQ)

We offer

  • Variod working environment in a future-proof industry
  • Cooperative atmosphere
  • Various enhancements
  • Attractive compensation
  • Flexible work time
  • In-house Cafeteria
  • Occupational Health Management and retirement Provision
  • Workplace childcare Center

While applying for the job please refer to jobvector

About Rentschler Biopharma SE

Rentschler Biopharma ist ein weltweit agierendes Dienstleistungsunternehmen für die Entwicklung und Produktion von Biopharmazeutika und beschäftigt rund 800 Mitarbeiter. Wir bieten unseren Kunden ein Full-Service-Konzept von der Entwicklung der Zelllinie bis zur Bereitstellung des Biopharmazeutikums sowohl für klinische Studien wie auch für die Marktversorgung. Unsere...

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