Process Manager (m/f/d) MSAT Upstream - 2 year contract

Medizin vorantreiben, um Leben zu schützen. Gemeinsam.

Dank vieler Jahrzehnte Erfahrung und unserer Leidenschaft für das, was wir tun, leisten wir einen essenziellen Beitrag zur weltweiten Verfügbarkeit von Biopharmazeutika, auch und gerade für Patienten mit seltenen und schweren Erkrankungen.

Rentschler Biopharma SE ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) und ausschließlich auf Kundenprojekte fokussiert. Wir bieten maßgeschneiderte Full-Service-Lösungen für die Bioprozessentwicklung und die Herstellung komplexer Biopharmazeutika. Als deutsches Familienunternehmen mit internationalem Footprint und globaler Reichweite verbinden wir Experten, Expertise und langjährige Erfahrung, um zusammen mit unseren Kunden beste Lösungen zu entwickeln.

Rentschler Biopharma beschäftigt rund 1.400 Mitarbeiter und hat den Hauptsitz in Laupheim, Deutschland, sowie einen Standort in Milford, MA, USA. Im Jahr 2024 haben wir uns dem Global Compact der Vereinten Nationen angeschlossen und unterstreichen damit unser Engagement für Nachhaltigkeit.

Als unabhängiges Familienunternehmen leben wir nach dem Motto: Many hands, many minds – ONE TEAM! Ein offenes, respektvolles Miteinander prägt unsere Arbeitswelt, in der Qualitätsbewusstsein, Sorgfalt und Verantwortung an erster Stelle stehen. Denn bei aller Vielfalt unserer Talente im Rentschler Team verfolgen wir gemeinsam einen Zweck: Medizin voranzutreiben, um Leben zu schützen.

The Process Manager (m/f/d) will oversee 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 within our internal network and to external manufacturing sites

• Support of process qualification and validation at manufacturing scale

• Definition of control strategies for commercial manufacturing

• Setup and performance of continued process verification

Further tasks and responsibilities

• 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

What is important to us

• University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field

• Multiple years of experience in upstream 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

• Expertise in biotechnological processes, with an emphasis on and experience with commercial products

• Experience in continued process verification (CPV)

• Know-how in statistical concepts and tools

• Knowledge of downstream processing is a plus

• Process qualification/validation (PPQ) experience

What you can look forward to

• Meaningful Work: Become part of a company that makes a real difference for critically ill patients by developing and producing vital medications

• Inspiring Work Atmosphere: Experience the joy of working in a collegial environment that promotes collaboration and team spirit on-site

• Individual Development Opportunities: Access to personalized training programs

• Compensation: Attractive salary and 13th-month salary

• Flexible Work Arrangements: Flexible working hours, options for remote work, 30 vacation days, and special leave days

• Communal Breaks: Cafeteria with vegetarian/vegan options

• Health: Corporate health management, company doctor, EGYM Wellpass

• Shared Experiences: Team and company events

• Employee Benefits: Variety of employee discounts (corporate benefits), discounts on the job ticket, financial relocation support beyond a certain distance, free parking, comprehensive onboarding program