Rentschler Biopharma SE
Prozessingenieur Downstream Production(m/w/x)
Full-timeWith HomeofficeExperienced
Laupheim
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RERentschler Biopharma SE
Process Manager - MSAT - DSP(m/w/x)
Laupheim
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Designing scalable downstream processes for biopharmaceuticals in a CDMO, defining control strategies, with direct customer communication. Multiple years of experience in biopharmaceutical downstream processing with scalable technologies required. Direct customer interaction, cross-departmental collaboration.
Requirements
- University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field
- Multiple years of experience in downstream processing using scalable technologies in biopharmaceutical manufacturing
- Strong and motivating communication skills
- Team spirit
- Flexibility
- High level of initiative
- Personal responsibility
- Excellent organizational skills
- Entrepreneurial mindset
- Economic and analytical thinking
- Fluency in English
- Relevant experience with commercial products CPV will be considered an asset
- Experience in process performance qualification (PPQ) is desirable
- Know-how in statistical concepts and software (e.g. JMP) is a plus
Tasks
- Design robust and scalable downstream processes for biopharmaceuticals
- Define control strategies for commercial manufacturing
- Set up and perform continued process verification (CPV)
- Communicate directly with customers in meetings and conference calls
- Collaborate with colleagues from associated departments
- Troubleshoot and optimize processes at manufacturing scale
- Participate in deviations, out-of-specifications, and change management
- Review and own process descriptions, risk assessments, protocols, and reports
- Ensure compliance with international technological and regulatory standards
- Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
- Participate in client audits and authority inspections
- Engage in process optimization and innovation projects
- Continuously strive for improvement and optimization in all work areas
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- JMP
Benefits
Competitive Pay
- Attractive salary
Bonuses & Incentives
- 13th-month salary
Informal Culture
- Collegial work environment
Learning & Development
- Personalized training programs
- Comprehensive onboarding program
Flexible Working
- Flexible working hours
- Flexitime account
- Options for remote work
More Vacation Days
- 30 vacation days
- Special leave days
Free or Subsidized Food
- Cafeteria with vegetarian/vegan options
Healthcare & Fitness
- Corporate health management
- Company doctor
Retirement Plans
- Company pension plan
Team Events
- Team and company events
Company Bike
- Leasing options for (e-)bikes
Childcare
- In-house daycare center
Job Security
- Permanent employment contract
Corporate Discounts
- Variety of employee discounts
Public Transport Subsidies
- Discounts on job ticket
Additional Allowances
- Financial relocation support
Parking & Commuter Benefits
- Free parking
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Rentschler Biopharma SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Nejo AI Summary
Designing scalable downstream processes for biopharmaceuticals in a CDMO, defining control strategies, with direct customer communication. Multiple years of experience in biopharmaceutical downstream processing with scalable technologies required. Direct customer interaction, cross-departmental collaboration.
Requirements
- University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field
- Multiple years of experience in downstream processing using scalable technologies in biopharmaceutical manufacturing
- Strong and motivating communication skills
- Team spirit
- Flexibility
- High level of initiative
- Personal responsibility
- Excellent organizational skills
- Entrepreneurial mindset
- Economic and analytical thinking
- Fluency in English
- Relevant experience with commercial products CPV will be considered an asset
- Experience in process performance qualification (PPQ) is desirable
- Know-how in statistical concepts and software (e.g. JMP) is a plus
Tasks
- Design robust and scalable downstream processes for biopharmaceuticals
- Define control strategies for commercial manufacturing
- Set up and perform continued process verification (CPV)
- Communicate directly with customers in meetings and conference calls
- Collaborate with colleagues from associated departments
- Troubleshoot and optimize processes at manufacturing scale
- Participate in deviations, out-of-specifications, and change management
- Review and own process descriptions, risk assessments, protocols, and reports
- Ensure compliance with international technological and regulatory standards
- Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
- Participate in client audits and authority inspections
- Engage in process optimization and innovation projects
- Continuously strive for improvement and optimization in all work areas
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- JMP
Benefits
Competitive Pay
- Attractive salary
Bonuses & Incentives
- 13th-month salary
Informal Culture
- Collegial work environment
Learning & Development
- Personalized training programs
- Comprehensive onboarding program
Flexible Working
- Flexible working hours
- Flexitime account
- Options for remote work
More Vacation Days
- 30 vacation days
- Special leave days
Free or Subsidized Food
- Cafeteria with vegetarian/vegan options
Healthcare & Fitness
- Corporate health management
- Company doctor
Retirement Plans
- Company pension plan
Team Events
- Team and company events
Company Bike
- Leasing options for (e-)bikes
Childcare
- In-house daycare center
Job Security
- Permanent employment contract
Corporate Discounts
- Variety of employee discounts
Public Transport Subsidies
- Discounts on job ticket
Additional Allowances
- Financial relocation support
Parking & Commuter Benefits
- Free parking
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Rentschler Biopharma SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Rentschler Biopharma SE
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein führender Auftragsentwicklungs- und Herstellungsbetrieb (CDMO), der sich auf biopharmazeutische Lösungen spezialisiert hat.
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