Process Manager (m/w/d) MSAT DSP

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

Ihre Aufgaben

The Process Manager oversees the downstream processes of our customers' APIs throughout the 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 downstream 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,

• 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

Ihr Profil

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

• Multiple years of experience in downstream 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 process transfers and scale-up

• Know-how in statistical concepts and tools

• Knowledge of upstream processing is a plus

• Process qualification/validation (PPQ) experience is a plus

Wir bieten Ihnen

• Work in a company that offers real value and manufactures medicines for critically ill patients

• Contagious joy in the job as well as a collegial working environment

• Access to exclusive, personalised training through the Rentschler Academy

• 30 days of holiday

• Flexible working hours, flexitime account and mobile working

• Responsibility, initiative, further development

• Team and company events

• Company health management and pension scheme

• Various employee discounts

• Company child-care centre

• Future-proof industry

• Unlimited contract