Advancing medicine to save lives. Together.
Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.
Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.
Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.
As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.
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- Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
- Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy
- Advise teams and clients on strategic decisions regarding cQAs and QbD based development of biopharmaceuticals
- 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
- We are seeking a candidate with strong expertise in either immunology and/or clinical studies, including knowledge of safety profiles of biopharmaceuticals, or a solid understanding of protein chemistry at the molecular level. In both cases, a strong ability to interpret and communicate complex analytical data is essential
- Degree in Life Sciences (pharmacy, immunology, biochemistry, etc) preferably with PhD, or several years of industrial experience within the biopharmaceutical field
- Profound knowledge regarding the assessment of product quality attributes in respect to efficacy, safety and pharmacokinetics in the lifecycle of biopharmaceutical products
- Sound knowledge on chromatographic and/or electrophoretic analytical methods and/or immunoassays
- Proficiency in MS-Office programs and fluency in English
- 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
- 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
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What We Do
Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, including advanced therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA and Stevenage, UK. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability
