Process Manager - Downstream Process Development

DSP Process Manager

Rentschler Biopharma SE is a leading contract development and manufacturing organization focused exclusively on client projects.

• Develop scalable and robust downstream processes for clinical and commercial GMP manufacturing.
• Design experiments related to development, optimization, and scale‑up of all steps of various recombinant protein formats (e.g., antibodies, bispecifics, and enzymes) inclusive of viral clearance studies.
• Lead lab team members in the execution of experiments.
• Apply Design of Experiments (DoE) and other advanced statistical techniques to design and evaluate late‑stage development activities and process characterization studies in preparation for process qualification and validation at manufacturing scale.
• Define the control strategy for commercial manufacturing.
• Interface with clients: analyze, prepare, and formally present data; author and collaborate on client‑approved documents.
• Provide technical consulting as a subject‑matter expert.
• Transfer programs to manufacturing.
• Provide process descriptions and gap analyses.
• Collaborate with MSAT on change controls, deviations, and investigations.
• Support manufacturing and MSAT as a process subject‑matter expert, including floor support.
• Author high‑quality documents such as experimental protocols, technical reports, risk/gap assessments, SOPs, and facility fit assessments.
• Assist with and review relevant chapters of CMC dossier sections for IND/IMPD and BLA/MAA.
• Review batch records as a process and subject‑matter expert.
• Lead, train, and mentor junior lab staff.
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
• Contribute to the overall operations of the process sciences laboratory and infrastructure improvements.
• Act as an active contributor/connector on harmonization and alliance of concepts, procedures, techniques, and documentation within international sites of the company.
• Serve as Process Science representative and participate in cross‑functional meetings.

• Years of experience and education (choose one): university degree and 5‑8+ years of related experience;
  Master’s degree and 3‑5+ years;
  PhD and 1‑3+ years.
• Expertise in chromatographic processes, filtration techniques, protein chemistry, and associated analytical methods.
• Expertise in scale‑up/scale‑down principles and the use of statistical tools for data analysis and DoE.
• Experience in process characterization, qualification/validation (PPQ) and/or continued process verification (CPV) is preferred.
• Experience in viral clearance validation and scale‑down validation is preferred.
• Advanced proficiency with required software (Unicorn, JMP/Modde, Word, Excel, PowerPoint).
• Demonstrated critical thinking, self‑motivation, accountability, inquisitiveness, and excellent organization and communication skills.
• Ability to work independently and as a member of local and global teams.
• Excellent customer service skills and ability to meet client project deadlines.
• Basic knowledge of project management.
• Flexibility of hours to support process development or manufacturing floor activities over weekends and holidays; weekend and holiday hours are compensated per company policies.
• Flexibility to switch between projects.

• 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‑paced environment with job completion deadlines.
• Physical requirements:
  
  frequent lifting up to 10 lbs; sitting for extended periods for computer‑based work; standing/walking to work in the lab environment for extended periods.

Base Pay Range: $120,000 - $145,000. The total rewards package includes an annual discretionary bonus program, medical insurance, a generous 401(k) program, and other benefits aligned with supporting employees’ personal and professional wellness.