Process Manager, Upstream Process Development

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! Duties and Responsibilities Develop clinical and commercial processes for Upstream unit operations including harvest Design and evaluate experiments to develop, optimize, characterize, or scale-up/ scale down processes Employ QbD principles when using univariate and multivariate studies in preparation for PPQ campaigns Align and harmonize methods and approaches with international colleagues Lead, train, and mentor junior lab staff Identify and evaluate new and existing technologies for more efficient processing, improved control, and increased process knowledge Contribute to process science ways-of-working and infrastructure improvements Transfer programs to manufacturing. Provide process descriptions and gap analysis Collaborate with MSAT on change controls Support Manufacturing and MSAT as the process Subject Matter Expert Support Manufacturing and Quality with deviation closures and appropriate CAPAs Interface with clients. Analyze, prepare, and formally present data Collaborate on client approved documents Provide technical consulting as a Subject Matter Expert Author documents Experimental protocols, technical reports, risk assessments, gap assessments, SOPs, facility fit assessments Process Subject Matter Expert review on batch records CMC dossier sections for IND/ IMPD and BLA/ MMA Qualifications Years of experience and education (one of the following): A university degree and 10+ years of related experience A Master's degree and 7+ years A PhD and 5+ years of experience Expertise 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 departments The 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 teams Excellent customer service skills and ability to meet client project deadlines Flexibility of hours to support process development or MFG floor activities over weekends and holidays. Weekend and holiday hours are compensated per company policies Flexibility to switch between projects Advanced ability with Microsoft Office (Word, Excel, and PowerPoint) Preferred Qualifications AMBR and single-use vessels Clarification (Harvest) unit operations and principles Process Qualification/ Process Validation (PPQ) QbD principles Continued Process verification (CPV) Regulatory requirements Experience with audits Working Conditions Laboratory and manufacturing clean-room environments working with chemical reagents and processing equipment Compliance with Personal Protective Equipment, clean room gowning, and EH&S requirements Normal office working conditions: computer, phone, files, printer, etc Interaction with people in the lab, other departments, and clients Fast-pace environment with job completion deadlines Physical Requirements Lifting up to 25 lbs Standing/walking in lab environment for extended periods Sitting in office environment for extended periods for computer-based work

Created: 2025-03-10