Process Manager

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. Process Managers oversee the downstream processes of our customers’ APIs throughout the complete product life cycle. In the commercial stage 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 commercial timelines and overall business plansDefinition of control strategies for commercial manufacturingSetup and performance of continued process verification (CPV) Further tasks and responsibilitiesDirect communication and representation towards customers in face-to-face meetings and conference callsInterdisciplinary and cross-functional interaction with colleagues from associated departmentsTroubleshooting and process optimization at manufacturing scaleParticipation in deviations, out-of-specifications, and change managementOwnership and review of process descriptions, risk assessments, protocols, and reportsEnsuring compliance with international technological and regulatory standardsReview of relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)Participation in client audits and authority inspectionsInvolvement in process optimization and innovation projectsContinuous striving for improvement and optimization in all areas of work What is important to usUniversity degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical fieldMultiple years of experience in downstream processing using scalable technologies in the context of biopharmaceutical manufacturingStrong and motivating communication skills, team spirit, and flexibilityHigh level of initiative, personal responsibility, and excellent organizational skillsEntrepreneurial mindset, economic and analytical thinkingFluency in EnglishRelevant experience with commercial products CPV will be considered an assetExperience in the field of process performance qualification (PPQ) is desirableKnow-how in statistical concepts and software (e.g. JMP) is a plusWhat we offerMeaningful Work: Become part of a company that makes a real difference for critically ill patients by developing and producing vital medicationsInspiring Work Atmosphere: Experience the joy of working in a collegial environment that promotes collaboration and team spirit on-siteIndividual Development Opportunities: Access to personalized training programsCompensation: Attractive salary and 13th-month salaryFlexible Work Arrangements: Flexible working hours, flexitime account, options for remote work, 30 vacation days, and special leave daysCommunal Breaks: Cafeteria with vegetarian/vegan optionsHealth: Corporate health management, company doctor, company pension planShared Experiences: Team and company eventsEco-friendly Mobility: Leasing options for (e-)bikes, e-scooters, and e-scootersFamily-friendly Support: In-house daycare centerSecure Workplace: Future-proof industry with a permanent employment contractEmployee Benefits: Variety of employee discounts (corporate benefits), discounts on the job ticket, financial relocation support beyond a certain distance, free parking, comprehensive onboarding program