Process Manager, Upstream MSAT

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. The Process Manager in the MSAT group is a functional project (s) lead, who will independently design, execute, and support manufacturing activities and processes including technology transfer activities both from the client(s), Process Science and internally to GMP manufacturing facility. Duties And Responsibilities Independent planning and design of demanding function-related tasks in customer projects, with pronounced interface management and complexity as a specialist/process expertProvide technical and strategic planning support for business development activities with respect to new client projects and new business initiativesIndependent decision-making in changing processes and action patternsDirect communication and representation to our customers in face-to-face as well as virtual meetings for your own project section, which may include management of meetingsAdvising our customers on the specialist project strategy over the product life cycle.Collaborating with Process Science for designing, supporting and developing scalable upstream for a broad range of biopharmaceuticals to include definition of required control strategiesTransfer of customer processes (upstream) to internal and external production sites through execution of the New Product Introduction (NPI) processEnsure compliance with international technological and regulatory standardsResponsible for meeting timelines and milestones according to the overall project plan to include management of resources to accomplish objectivesCollaboration as a technical expert in an interdisciplinary and cross-functional project team Timely creation and review of protocols and reportsParticipation in customer audits and inspections by authoritiesSupporting the quotation process in collaboration with Business DevelopmentOnboarding and orientation of new employeesLead gap assessment between sites, tech transfer and Process Science and author of technical gap assessment reportSupport manufacturing for critical USP unit operationsReview and approve Master Batch Record, SOP, and FingerprintsProvide Process training to manufacturing, technical operations, Quality assurance for the new campaignAuthoring technical reports as required Qualifications Years of Experience (one of the following): A university degree in STEM and 8+ years of related experienceA master’s degree in STEM and 5+ yearsA PhD in STEM and 3+ years of experience Preferred Technical Experience Expertise in Single Use Bioreactors and related process equipment, inoculum scale-up, large scale mammalian cell culture, Perfusion/continuous processing, Harvest processing to include depth filtration and centrifugation, scale up, and associated In Process Control (IPC) methods. A familiarity with process control systems is essentialExperience in GMP guidance, process performance qualification/validation (PPQ) and continued process verification (CPV)/Process monitoringAdvanced ability with Microsoft Office (Word, Excel, Project, Visio, and PowerPoint), and Statistical analysis packages for data management and presentationTechnical writing for memoranda, reports, protocols and similar documents General Attributes The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skillsHigh level of initiative with an entrepreneurial mindset and analytical thinkingDemonstrates ability to work both independently and as a member of local / global teamsExcellent customer service skills and ability to meet client project deadlines.Flexibility to switch between projects Working Conditions GMP manufacturing environment working with biologics and chemicalsPersonal Protective Equipment must be worn as requiredNormal office working conditionsWill interact with a cross functional teamPace may be fast and job completion demands may be high Physical Requirements Frequent lifting up to 25 lbsFrequent standing/walking to work in GMP production environment for extended periodsFrequent sitting for extended periods to use computer ____________________________________________________________________________ Base Pay Range $XXX,XXX - $XXX,XXX Disclosure Statement Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.