Sr Engineer, Downstream 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. 

Duties and Responsibilities

• Lead Technology transfer of client products working closely in collaboration with process development, Manufacturing, Engineering and Quality
• Partner with Process Science to ensure the design and scale up of processes, instruments, and equipment from the laboratory through pilot scale are executable by manufacturing operations when moving into full scale manufacturing
• Partner with manufacturing to ensure that manufacturing operations are designed for success ensuring high quality batch records, robust processes, and new technology
• Anticipate, respond to, and resolve issues that arise on the floor in production through use of master data, process, and product monitoring
• Utilize MSAT team’s technical skills and process knowledge to participate and/or lead process investigations through to root cause determination. Collaborate within the organization to develop and execute effective CAPA
• Proactively drive Process Performance Qualification together with MSAT USP, Process Science, Regulatory, Manufacturing, Validation and Quality
• Leads process monitoring and control of manufacturing processes and continuous improvement programs
• Provide troubleshooting, technical support and training on the shop floor
• Regularly interact with Rentschler senior management and clients; interactions involve use of influencing, conflict resolution and balancing the interests of the clients with those of Rentschler
• Work closely with clients to ensure that their projects are executed successfully through the transfer, implementation, validation, filing and licensing of their products
• Partner with MSAT network teams and peers to share and adopt best practices and drive continuous improvement in all technical aspects of production
• Support the business development function by providing technical expertise for Process facility fit evaluations and responses for RFPs
• Responsible for authoring technical reports, manufacturing instructions, process validation documents and portions of regulatory submissions to support licensing client products and process changes
• Support regulatory filings and responses to health authority questions. Author and review CMC sections for IND and BLA submissions

Qualifications

• Bachelor’s degree in STEM
• 5+ years of related experience
• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
• Experience with biologics drug substance process development and/or manufacturing operations
• Experience in process transfer in and manufacturing technical operations
• Experience leading process technology transfers for clinical or commercial biologic(s)
• Experience with Quality systems such as Deviation, CAPA, Change Control systems
• Escalate and resolve project issues/ roadblocks as appropriate
• Ability to identify and resolve complex technical issues including quality investigations
• Advanced proficiency with Microsoft Office

Preferred Qualifications

• Previous experience in a Contract Development Manufacturing Organization (CDMO) environment
• Experience in process qualification/validation (PPQ) and/or continued process verification (CPV)
• Unicorn, JMP, and MODDE

Working Conditions

• Normal office working conditions: computer, phone, files, fax, copier
• Personal Protective Equipment must be worn as required