**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.

**As Product Expert / Analytical Process Manager you are responsible for the implementation of the Quality-by-Design (QbD) concept as well as all activities of the Analytical Science group in customer projects.**

# **Tasks and responsibilities**

- Representation of Analytical Science in the customer project teams
- Coordination of activities of Analytical Science for the assigned customer projects including external biophysical analytical activities
- Scientific contributions and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
- Implementation of the QbD strategy in the respective customer project teams
- Advise teams and clients on strategic decisions regarding cQAs and QbD based development of biopharmaceuticals
- Responsibility for adhering to timelines and milestones according to the overall project plan
- Contribution to risk assessments regarding product quality
- Preparing and writing reports and presentations in English language
- Presentation of results and strategic topics in internal meetings, customer meetings, audits and scientific conferences

# **What is important to us**

- Degree in Life Sciences (pharmacy, immunology, chemistry, biochemistry, etc) preferably with PhD, or several years of industrial experience within biopharmaceutical fields
- Profound knowledge regarding the assessment of product quality and especially cQAs in the lifecycle of biopharmaceutical products
- Sound knowledge on chromatographic and/or electrophoretic analytical methods and/or immunoassays
- Very good knowledge in immunology and/or medical /pharmaceutical knowledge with experience in the field of pharmacokinetics /-dynamics of biopharmaceuticals
- Several years of experience in QbD-based biopharmaceutical development
- Proficiency in MS-Office programs and fluency in the English language
- Collaborative communication is one of your strengths and you present confidently in front of internal multidisciplinary team members and external customers
- You are scientifically curious, think analytically and work efficiently in a dynamic multifaceted task field
- You are a team player and have a very high level of initiative and organizational skills

# **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, flexitime account, options for remote work, 30 vacation days, and special leave days
- **Communal Breaks:** Cafeteria with vegetarian/vegan options
- **Health**: Corporate health management, company doctor
- **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