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Rentschler Biopharma SE

Process Manager Manufacturing Science & Technology, USP (m/w/d)

 ID-NR.: 77886
 zuletzt aktualisiert: 05.05.2021 Arbeitsort: 88471 Laupheim
 Beschäftigung: Vollzeit Wochenstunden: keine Angaben
 Spezialisierung: keine Angaben Arbeitsbeginn: zum nächstmöglichen Termin
As a global leading service provider for the development and production of biopharmaceuticals, Rentschler Biopharma makes an essential contribution to the worldwide availability of life-saving therapeutics. We are a family-owned company with approximately 1000 employees. Going forward, we are expanding our team to ensure our consistent growth.
What unites us at Rentschler Biopharma, is the passion for what we do. Every individual member of our team contributes actively to project success with his/her knowledge and skills. Come join our team! We offer you an exciting work environment with excellent career development opportunities.

As part of our group Manufacturing Science and Technology Downstream Processing, we are seeking a

Process Manager Manufacturing Science & Technology, USP (m/w/d)

The Process manager will be in charge of the upstream 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 upstream processes for a wide range of biopharmaceuticals in line with clinical and commercial timelines and overall business plans
  • Process scale up and transfer to our internal and external manufacturing sites
  • Design of late stage development activities and process characterization studies in preparation of…
  • …Process qualification and validation at manufacturing scale
  • Definition of control strategy 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 our 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 deviation, out-of-specification and change management
  • Compilation and review of 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

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 upstream processing using scalable technologies in the context of biopharmaceutical manufacturing
  • Strong and motivating communication skills, team spirit and flexibility
  • High level of initiative and excellent organizing skills
  • Entrepreneurial mindset, economic and analytical thinking
  • Fluent in German and English

Preferred qualifications:

  • Expertise in cell culture processes, filtration techniques and respective analytical methods
  • Experience in process qualification/validation (PPQ) and/or continued process verification (CPV)
  • Knowhow in statistical concepts and Tools

We offer:

  • Multifaceted and dynamic working environment in a future-proof industry
  • Cooperative atmosphere
  • Flexible work time and attractive compensation
  • Occupational Health Management and retirement provision
  • In-house cafeteria and child day care center

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Rentschler Biopharma SE Telefon: 
  Email: keine Angaben
Ansprechpartner:  Frau Flock Homepage: Homepage
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Branche: Chemie/Biotechnologie/Pharma, Pharma
Position: Fachkraft mit Berufserfahrung

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