Process Manager, Upstream Process Development

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. Duties And ResponsibilitiesDevelop clinical and commercial processes for Upstream unit operations including harvestDesign and evaluate experiments to develop, optimize, characterize, or scale-up/ scale down processesEmploy QbD principles when using univariate and multivariate studies in preparation for PPQ campaignsAlign and harmonize methods and approaches with international colleaguesLead, train, and mentor junior lab staffIdentify and evaluate new and existing technologies for more efficient processing, improved control, and increased process knowledgeContribute to process science ways-of-working and infrastructure improvementsTransfer programs to manufacturing.Provide process descriptions and gap analysisCollaborate with MSAT on change controlsSupport Manufacturing and MSAT as the process Subject Matter ExpertSupport Manufacturing and Quality with deviation closures and appropriate CAPAsInterface with clients.Analyze, prepare, and formally present dataCollaborate on client approved documentsProvide technical consulting as a Subject Matter ExpertAuthor documentsExperimental protocols, technical reports, risk assessments, gap assessments, SOPs, facility fit assessmentsProcess Subject Matter Expert review on batch recordsCMC dossier sections for IND/ IMPD and BLA/ MMA QualificationsYears of experience and education (one of the following):A university degree and 10+ years of related experienceA Master’s degree and 7+ yearsA PhD and 5+ years of experienceExpertise in bioreactor operation, scale-up/ scale-down principles, the use of statistical tools for data analysis and DoE, CMC dossier sections relating to process definitions, and working effectively with other departmentsThe candidate must demonstrate critical thinking, be self-motivated, accountable, inquisitive, and have excellent organization and communication skills, and demonstrates the ability to work both independently and as a member of local and global teamsExcellent customer service skills and ability to meet client project deadlinesFlexibility of hours to support process development or MFG floor activities over weekends and holidays. Weekend and holiday hours are compensated per company policiesFlexibility to switch between projectsAdvanced ability with Microsoft Office (Word, Excel, and PowerPoint) Preferred QualificationsLate-stage development and process characterizationAMBR and single-use vesselsClarification (Harvest) unit operations and principlesProcess Qualification/ Process Validation (PPQ)QbD principlesContinued Process verification (CPV)Regulatory requirementsExperience with audits Working ConditionsLaboratory and manufacturing clean-room environments working with chemical reagents and processing equipmentCompliance with Personal Protective Equipment, clean room gowning, and EH&S requirementsNormal office working conditions: computer, phone, files, printer, etcInteraction with people in the lab, other departments, and clientsFast-pace environment with job completion deadlines Physical RequirementsLifting up to 25 lbsStanding/walking in lab environment for extended periodsSitting in office environment for extended periods for computer-based work____________________________________________________________________________Base Pay Range$120,000 - $145,000Disclosure StatementRentschler 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.