Process Manager Downstream Development (m/w/d)

88471 Laupheim, 88471 Laupheim
05.10.2020

Daten dieser Anzeige

Job-ID: 017270839
Process Manager Downstream Development (m/w/d)

Rentschler Biopharma SE

Germany

https://www.rentschler-biopharma.com/de/karriere/stellenangebote/?yid=1218&agid=20

Design and development of scalable downstream processes from bench to commercial scale for a wide range of biopharmaceuticals Transfer of customer downstream processes to the Rentschler process format. Design of late stage process optimization and process characterization / robustness studies by risk based strategies in preparation of process validation at manufacturing scale 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», conference calls, etc. Consulting our customers in subject matter-specific project strategy within the product lifecycle Ensure compliance with international technological and regulatory standards Responsible for compliance of timelines and milestones according to overall project plans Technical supervision of lab technicians and engineers in DSP development Scientific advice for manufacturing science and technology team (scale up to internal and external production sites, deviations, changes, process validation) Subject matter expert in an interdisciplinary and cross-functional team with colleagues from production, USP, quality control, QA/RA and Innovation Compile and review protocols and reports in a timely manner Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA) Participate in customer audits and authority inspections Participate in innovation and internal projects for driving progress of the group / Company

Process Manager Downstream Development (m/w/d) As part of our group Process Science DSP, we are seeking a Process Manager. The Process Manager will be in charge of the upstream/downstream processes of our customers' APIs throughout the complete product lifecycle. This comprises the following key responsibilities: Job Description Design and development of scalable downstream processes from bench to commercial scale for a wide range of biopharmaceuticals Transfer of customer downstream processes to the Rentschler process format. Design of late stage process optimization and process characterization / robustness studies by risk based strategies in preparation of process validation at manufacturing scale 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», conference calls, etc. Consulting our customers in subject matter-specific project strategy within the product lifecycle Ensure compliance with international technological and regulatory standards Responsible for compliance of timelines and milestones according to overall project plans Technical supervision of lab technicians and engineers in DSP development Scientific advice for manufacturing science and technology team (scale up to internal and external production sites, deviations, changes, process validation) Subject matter expert in an interdisciplinary and cross-functional team with colleagues from production, USP, quality control, QA/RA and Innovation Compile and review protocols and reports in a timely manner Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA) Participate in customer audits and authority inspections Participate in innovation and internal projects for driving progress of the group / Company Requirements PhD or relevant experience in biotechnology, biochemistry or comparable scientific/technical field  Several years of active experience in the field of DSP development preferably using scalable technologies in context of industrial pharmaceutical manufacturing Deep knowledge and understanding of chromatographic processes, filtration techniques, protein chemistry and analytical methods Significant knowledge in upstream processing Fluent in German and English Basic knowledge in project management High level of initiative and excellent organizing ability Entrepreneurial mindset, economic and analytical thinking Strong and collaborative communication skills, team spirit, flexibility and outcome-oriented working Willingness to work at weekends The position is located in salary range 7.   Employees who meet the requirements or wish to develop the skills for the position (employees wishing to reorientate the focus of their career will be thoroughly trained), are welcome to send their application to our Human Relations department. Kinga Brigitta Gordi (phone no. +49 7392 701-239) and Dr. Matthias Kron (phone no. +49 7392 701-1120) are happy to provide further Information. Jetzt bewerben!

Pharma, Chemie, Med.-/ Biotechnologie

Medizinische Tätigkeiten/ Gesundheits-/ Sozialwesen

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

88471 Laupheim