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 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 improvements
Transfer programs to manufacturing.Provide process descriptions and gap analysis
Collaborate 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 data
Collaborate on client approved documentsProvide technical consulting as a Subject Matter ExpertAuthor documentsExperimental protocols, technical reports, risk assessments, gap assessments, SOPs, facility fit assessments
Process Subject Matter Expert review on batch recordsCMC dossier sections for IND / IMPD and BLA / MMAQualifications
Years of experience and education (one of the following) :A university degree and 10 years of related experience
A 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 Qualifications
AMBR and single-use vesselsClarification (Harvest) unit operations and principlesProcess Qualification / Process Validation (PPQ)QbD principlesContinued Process verification (CPV)Regulatory requirementsExperience with auditsWorking Conditions
Laboratory and manufacturing clean-room environments working with chemical reagents and processing equipmentCompliance with Personal Protective Equipment, clean room gowning, and EH&S requirements
Normal office working conditions : computer, phone, files, printer, etcInteraction with people in the lab, other departments, and clientsFast-pace environment with job completion deadlinesPhysical Requirements
Lifting up to 25 lbsStanding / walking in lab environment for extended periodsSitting in office environment for extended periods for computer-based work
