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

Rentschler Biopharma, Inc.; Laupheim; Hybrid; EUR 110,000 - 135,000; Full time

Benefits offered by this job

Meaningful Work

On-site atmosphere

Development opportunities

13th-month salary

Flexible work hours

Remote work options

30 vacation days

Cafeteria options

Health management

Job summary

Rentschler Biopharma, Inc. is seeking a Process Manager (m/f/d) to oversee upstream processes across the product lifecycle.

You will design robust processes, manage scale-up and transfers, and support process qualification, validation, and control strategies in collaboration with Process Science and Manufacturing teams. The role requires a university degree in a relevant field, multiple years of upstream experience, strong communication, initiative, and English fluency.

Qualifications

• University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable field.
• Multiple years of experience in upstream processing using scalable biopharmaceutical technologies.
• Excellent communication, teamwork, and flexibility.
• High initiative, personal responsibility, and strong organizational skills.
• Fluency in English; CPV, PPQ experience, and statistical concepts preferred.

Responsibilities

• Design robust, scalable upstream processes for a range of biopharmaceuticals.
• Scale-up and transfer of processes within internal networks and external sites.
• Support qualification and validation at manufacturing scale; define control strategies.
• Participate in deviations, change control, and audits; ensure regulatory compliance.

Skills

Strong communication

Team spirit

Flexibility

Initiative

Organizational skills

English fluency

CPV experience

PPQ experience

Statistical thinking

Education

University degree in biotechnology/bioprocess engineering

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 hasapproximately1,400 employees and is headquartered in Laupheim, Germany,with asite 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 (m/f/d) will oversee the upstream processes of our customers’ APIs throughout the complete product life cycle. This comprises the following key responsibilities which will be fulfilled in close collaboration with our Process Science and Manufacturing departments:

• 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 andconference 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