25 km

Rentschler Biopharma SE

1

Passende Jobs zu Ihrer Suche ...

... immer aktuell und kostenlos per E-Mail.
Sie können den Suchauftrag jederzeit abbestellen.
Es gilt unsere Datenschutzerklärung. Sie erhalten passende Angebote per E-Mail. Sie können sich jederzeit wieder kostenlos abmelden.

Informationen zur Anzeige:

Process Manager Manufacturing Science & Technology - Commercial Manufacturing, DSP (m/f/d)
Laupheim
Aktualität: 03.12.2022

Anzeigeninhalt:

03.12.2022, Rentschler Biopharma SE
Laupheim
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 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
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 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

Berufsfeld

Standorte