Process Manager, Upstream MSAT

Rentschler Biopharma SE; Milford (MA); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

401K

Annual bonus

Job summary

Rentschler Biopharma SE in Milford, MA, seeks an experienced Process Manager in the MSAT group to independently design, execute, and support manufacturing activities and technology transfer for client projects. You will lead cross-functional teams, drive process improvements, ensure regulatory compliance, and manage timelines while interfacing with customers and internal groups.

The role requires strong scientific background, GMP experience, and excellent communication; a strategic thinker

Qualifications

• University degree in STEM with substantial related experience.
• Masters or PhD preferred for senior technical leadership.
• Experience with GMP guidance, PPQ/CPV, and CPV monitoring.

Responsibilities

• Lead design and execution of manufacturing activities and tech transfer.
• Provide technical and strategic support for business development.
• Coordinate with Process Science and GMP Manufacturing to ensure compliance.
• Review protocols and reports; participate in customer audits.

Skills

Biopharma process development

Project leadership

Regulatory compliance

Technical writing

Data analysis

Education

Bachelor's or higher in STEM

Master's degree in STEM

PhD in STEM

Tools

Microsoft Project

Visio

PowerPoint

Excel

Job description

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. RentschlerBiopharmaSE 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. RentschlerBiopharma 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.

The Process Manager in the MSAT group is a functional project (s) lead, who will independently design, execute, and support manufacturing activities and processes including technology transfer activities both from the client(s), Process Science and internally to GMP manufacturing facility.

Duties and Responsibilities

• Independent planning and design of demanding function-related tasks in customer projects, with pronounced interface management and complexity as a specialist/process expert
• Provide technical and strategic planning support for business development activities with respect to new client projects and new business initiatives
• Independent decision-making in changing processes and action patterns
• Direct communication and representation to our customers in face-to-face as well as virtual meetings for your own project section, which may include management of meetings
• Advising our customers on the specialist project strategy over the product life cycle.
• Collaborating with Process Science for designing, supporting and developing scalable upstream for a broad range of biopharmaceuticals to include definition of required control strategies
• Transfer of customer processes (upstream) to internal and external production sites through execution of the New Product Introduction (NPI) process
• Ensure compliance with international technological and regulatory standards
• Responsible for meeting timelines and milestones according to the overall project plan to include management of resources to accomplish objectives
• Collaboration as a technical expert in an interdisciplinary and cross-functional project team
• Timely creation and review of protocols and reports
• Participation in customer audits and inspections by authorities
• Supporting the quotation process in collaboration with Business Development
• Onboarding and orientation of new employees Lead gap assessment between sites, tech transfer and Process Science and author of technical gap assessment report
• Support manufacturing for critical USP unit operations
• Review and approve Master Batch Record, SOP, and Fingerprints
• Provide Process training to manufacturing, technical operations, Quality assurance for the new campaign Authoring technical reports as required

Qualifications

Years of Experience (one of the following): A university degree in STEM and 8+ years of related experience A master’s degree in STEM and 5+ years A PhD in STEM and 3+ years of experience Preferred Technical Experience Expertise in Single Use Bioreactors and related process equipment, inoculum scale-up, large scale mammalian cell culture, Perfusion/continuous processing, Harvest processing to include depth filtration and centrifugation, scale up, and associated In Process Control (IPC) methods. A familiarity with process control systems is essential Experience in GMP guidance, process performance qualification/validation (PPQ) and continued process verification (CPV)/Process monitoring Advanced ability with Microsoft Office (Word, Excel, Project, Visio, and PowerPoint), and Statistical analysis packages for data management and presentation Technical writing for memoranda, reports, protocols and similar documents

General Attributes

The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills High level of initiative with an entrepreneurial mindset and analytical thinking Demonstrates ability to work both independently and as a member of local / global teams Excellent customer service skills and ability to meet client project deadlines. Flexibility to switch between projects

Working Conditions

GMP manufacturing environment working with biologics and chemicals Personal Protective Equipment must be worn as required Normal office working conditions Will interact with a cross functional team Pace may be fast and job completion demands may be high

Physical Requirements

Frequent lifting up to 25 lbs Frequent standing/walking to work in GMP production environment for extended periods Frequent sitting for extended periods to use computer ____________________________________________________________________________

Base Pay Range

Base Pay Range $120,000 - $145,000 Disclosure Statement Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.

RentschlerBiopharmaSE ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) und ausschließlich auf Kundenprojekte fokussiert. Wir bieten maßgeschneiderte Full-Service-Lösungen für die Bioprozessentwicklung und die Herstellung komplexer Biopharmazeutika. Als deutsches Familienunternehmen mit internationalem Footprint und globaler Reichweite verbinden wir Experten, Expertise und langjährige Erfahrung, um zusammen mit unseren Kunden beste Lösungen zu entwickeln. Wir leben nach dem Motto: Many hands, many minds - one team! Ein offenes, respektvolles Miteinander prägt unsere Arbeitswelt, in der Qualitätsbewusstsein, Sorgfalt und Verantwortung an erster Stelle stehen. Denn bei aller Vielfalt unserer Talente im Rentschler Team verfolgen wir gemeinsam einen Zweck: Medizin voranzutreiben, um Leben zu schützen.