Process Manager - Downstream Process Development

Rentschler Biopharma•Milford, MA

About The Position

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. We are seeking a proactive, strategic, and hands-on DSP Process Manager. They will demonstrate flexibility, adaptability, and can effectively work in a fast paced, rapidly changing CDMO environment. They are self-motivated, accountable, inquisitive, and have excellent organizational and communication skills. They can multi-task while delivering excellent customer service. The Process Manager in the Downstream Process Development group is a functional project(s) lead, who independently designs, executes, and support biologics downstream purification processes including technology transfer activities both from the client(s) and internally to the GMP manufacturing facility.

Requirements

Years of experience and education (one of the following): A university degree and 5-8+ years of related experience A Master’s degree and 3-5+ years A PhD and 1-3+ years of experience
Expertise in chromatographic processes, filtration techniques, protein chemistry, and associated analytical methods
Expertise in scale-up/scale-down principles as well as the use of statistical tools for data analysis and DoE
The candidate must demonstrate critical thinking, be self-motivated, accountable, inquisitive, 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
Basic knowledge of project management
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
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
Frequent lifting up to 10 lbs
Sitting for extended periods for computer-based work
Standing/walking to work in lab environment for extended periods
Advanced proficiency with required software — Unicorn, JMP/MODDE, Word, Excel, PowerPoint

Nice To Haves

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

Responsibilities

Develop scale-able and robust downstream processes for clinical and commercial GMP manufacturing.
Design experiments related to development, optimization, scale-up of all steps of various recombinant protein formats (e.g., antibodies, bispecific and enzymes) inclusive of viral clearance studies.
Lead lab team members in the execution of experiments.
Apply 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 process Subject Matter Expert, including on floor support.
Author high-quality documents. 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.
Process and Subject Matter Expert review on batch records.
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 process sciences lab and infrastructure improvements.
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.