Process Manager (m/f/d) MSAT Upstream - 2 year contract

Rentschler Biopharma SE; Laupheim; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

13th-month salary

Flexible working hours

Remote work options

30 vacation days

Cafeteria with vegetarian/vegan

Company health management

Company doctor

Relocation support

Free parking

Comprehensive onboarding

Job summary

Rentschler Biopharma SE is seeking a Process Manager to oversee upstream processes across the product lifecycle. You will design scalable, robust upstream processes and manage scale-up, tech transfer, and qualification activities for biopharmaceuticals.

You will lead cross-functional collaboration, support process verification, and help ensure regulatory-compliant manufacturing. English communication and project ownership are essential.

Qualifications

• University degree in biotechnology, pharmaceutical engineering or related field.
• Multiple years of upstream processing experience with scalable biopharma technologies.
• Strong communication, teamwork, flexibility, and initiative.
• English fluency; CPV/PPQ knowledge a plus.

Responsibilities

• Design robust upstream processes for biopharmaceuticals in line with timelines and business plans.
• Scale-up and transfer processes within internal network and external sites.
• Support process qualification and validation at manufacturing scale.
• Define control strategies for commercial manufacturing.
• Set up and perform continued process verification.
• Interact with customers in meetings and conference calls.
• Collaborate with cross-functional teams; troubleshoot at manufacturing scale.
• Participate in deviations, OOS, and change management.
• Own and review process descriptions, risk assessments, protocols and reports.
• Ensure compliance with international regulatory standards; review CMC dossiers.

Skills

Upstream processing exp

Communication & teamwork

Initiative & organization

English fluency

Analytical thinking

Education

University degree in biotech/related field

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. 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.

Process Manager (m/f/d) will oversee the upstream processes of our customers’ APIs throughout the complete product life cycle

• Design of robust, scalable, and economic upstream processes for a wide range of biopharmaceuticals in line with clinical and commercial timelines and overall business plans
• Process scale-up and transfer within our internal network and to external manufacturing sites
• Support of process qualification and validation at manufacturing scale
• Definition of control strategies for commercial manufacturing
• Setup and performance of continued process verification
• Further tasks and responsibilities
• Direct communication and representation towards customers in face-to-face meetings and conference calls
• Interdisciplinary and cross-functional interaction with colleagues from associated departments
• Troubleshooting and process optimization at manufacturing scale
• Participation in deviations, out-of-specifications, and change management
• Ownership and review of process descriptions, risk assessments, protocols, and reports
• Ensuring compliance with international technological and regulatory standards
• Review of relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
• Participation in customer audits and authority inspections
• Involvement in process optimization and innovation projects
• Continuously striving for improvement and optimization in all areas of work

What is important to us

• University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field
• Multiple years of experience in upstream processing using scalable technologies in the context of biopharmaceutical manufacturing
• Strong and motivating communication skills, team spirit, and flexibility
• High level of initiative, personal responsibility, and excellent organizational skills
• Entrepreneurial mindset, economic and analytical thinking
• Fluency in English
• Expertise in biotechnological processes, with an emphasis on and experience with commercial products
• Experience in continued process verification (CPV)
• Know-how in statistical concepts and tools
• Knowledge of downstream processing is a plus
• Process qualification/validation (PPQ) experience

What you can look forward to

• Meaningful Work: Become part of a company that makes a real difference for critically ill patients by developing and producing vital medications.
• Inspiring Work Atmosphere: Experience the joy of working in a collegial environment that promotes collaboration and team spirit on-site.
• Individual Development Opportunities: Access to personalized training programs.
• Compensation: Attractive salary and 13th-month salary.
• Flexible Work Arrangements: Flexible working hours, options for remote work, 30 vacation days, and special leave days.
• Communal Breaks: Cafeteria with vegetarian/vegan options.
• Health: Corporate health management, company doctor, EGYM Wellpass.
• Shared Experiences: Team and company events.
• Employee Benefits: Variety of employee discounts (corporate benefits), discounts on the job ticket, financial relocation support beyond a certain distance, free parking, comprehensive onboarding program.

Rentschler Biopharma is a 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. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. 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, we pursue one vision together: advancing medicine to save lives.