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 Responsibilities

• Develop clinical and commercial processes for Upstream unit operations including harvest
• 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
• Transfer programs to manufacturing.
• Interface with clients.
• Author documents
• 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
• Contribute to process science ways-of-working and infrastructure improvements
• 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
• Analyze, prepare, and formally present data
• Collaborate on client approved documents
• Provide technical consulting as a Subject Matter Expert
• 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):
• 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)
• A university degree and 10+ years of related experience
• A Master’s degree and 7+ years
• A PhD and 5+ years of experience

Preferred Qualifications

• Late-stage development and process characterization
• 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
• 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
• Compliance with Personal Protective Equipment, clean room gowning, and EH&S requirements

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