PAION Pharma GmbH
Associate Director Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSenior
Aachen
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PAPAION Pharma GmbH
Production Manager Pharma for Commercial API and Drug Product(m/w/x)
Aachen
Full-timeWith Home OfficeSenior
Nejo AI Summary
SME for API and drug product manufacturing, managing CMO interactions and GMP compliance. 5+ years in pharma/biotech with sterile injectables experience required. 30 days vacation, short communication channels.
Requirements
- Postgraduate/graduate in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Science
- At least 5 years in pharmaceutical or biotechnology industry
- Experience in API manufacturing, drug product manufacturing (steriles and injectables preferred), process chemistry, process development and validation, and manufacturing process lifecycle management
- Deep knowledge of GMP, ICH requirements, and EU/US requirements
- Proven knowledge of commercial manufacturing and on-time manufacture of APIs/drug products as technical expert with QA team
- Proven knowledge of managing change controls and deviations
- Proven knowledge of process validation
- Beneficial experience in technical management and direction of external vendors
- Beneficial experience in manufacturing of sterile products/injectables
- Knowledge of national regulatory requirements for Asian countries (Japan, Korea, China)
Tasks
- Become SME for API and drug product manufacturing
- Manage interaction with CMOs for API and drug product manufacture
- Review manufacturing documentation and Master Batch Records
- Ensure manufacturing is on-time and follows GMP guidelines
- Ensure manufacturing follows ICH requirements
- Ensure manufacturing follows PAION specifications and procedures
- Manage production-related change controls
- Manage production-related deviations
- Manage validation reports
- Manage risk assessments
- Perform Life Cycle Management of manufacturing processes
- Support Life Cycle Management of manufacturing processes
- Perform Continuous Improvement of manufacturing processes
- Support Continuous Improvement of manufacturing processes
- Perform process validation activities
- Review manufacturing processes
- Update manufacturing processes
- Improve manufacturing processes
- Incorporate EU GMP guideline updates into processes
- Incorporate other territory GMP guideline updates into processes
- Provide SME support to licensees on production topics
- Organize manufacturing process transfer programs
- Support manufacturing process transfer programs
- Provide technical support for registration documentation
- Maintain registration documentation
- Provide SME expertise for manufacturing facility audits
- Ensure audits follow GMP
- Ensure audits follow current guidelines
- Ensure audits follow internal procedures
Work Experience
- 5 - 7 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- 30 days vacation
Informal Culture
- Short communication channels
- Open doors
- Helpful colleagues
- Committed colleagues
Flexible Working
- Flexible working hours
- Partial home office
- Work-life balance
Healthcare & Fitness
- Supplementary health insurance
Retirement Plans
- Pension scheme
Modern Office
- Modern office building
Parking & Commuter Benefits
- Underground parking
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PAION Pharma GmbH 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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PAPAION Pharma GmbH
Production Manager Pharma for Commercial API and Drug Product(m/w/x)
Aachen
Full-timeWith Home OfficeSenior
Nejo AI Summary
SME for API and drug product manufacturing, managing CMO interactions and GMP compliance. 5+ years in pharma/biotech with sterile injectables experience required. 30 days vacation, short communication channels.
Requirements
- Postgraduate/graduate in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Science
- At least 5 years in pharmaceutical or biotechnology industry
- Experience in API manufacturing, drug product manufacturing (steriles and injectables preferred), process chemistry, process development and validation, and manufacturing process lifecycle management
- Deep knowledge of GMP, ICH requirements, and EU/US requirements
- Proven knowledge of commercial manufacturing and on-time manufacture of APIs/drug products as technical expert with QA team
- Proven knowledge of managing change controls and deviations
- Proven knowledge of process validation
- Beneficial experience in technical management and direction of external vendors
- Beneficial experience in manufacturing of sterile products/injectables
- Knowledge of national regulatory requirements for Asian countries (Japan, Korea, China)
Tasks
- Become SME for API and drug product manufacturing
- Manage interaction with CMOs for API and drug product manufacture
- Review manufacturing documentation and Master Batch Records
- Ensure manufacturing is on-time and follows GMP guidelines
- Ensure manufacturing follows ICH requirements
- Ensure manufacturing follows PAION specifications and procedures
- Manage production-related change controls
- Manage production-related deviations
- Manage validation reports
- Manage risk assessments
- Perform Life Cycle Management of manufacturing processes
- Support Life Cycle Management of manufacturing processes
- Perform Continuous Improvement of manufacturing processes
- Support Continuous Improvement of manufacturing processes
- Perform process validation activities
- Review manufacturing processes
- Update manufacturing processes
- Improve manufacturing processes
- Incorporate EU GMP guideline updates into processes
- Incorporate other territory GMP guideline updates into processes
- Provide SME support to licensees on production topics
- Organize manufacturing process transfer programs
- Support manufacturing process transfer programs
- Provide technical support for registration documentation
- Maintain registration documentation
- Provide SME expertise for manufacturing facility audits
- Ensure audits follow GMP
- Ensure audits follow current guidelines
- Ensure audits follow internal procedures
Work Experience
- 5 - 7 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- 30 days vacation
Informal Culture
- Short communication channels
- Open doors
- Helpful colleagues
- Committed colleagues
Flexible Working
- Flexible working hours
- Partial home office
- Work-life balance
Healthcare & Fitness
- Supplementary health insurance
Retirement Plans
- Pension scheme
Modern Office
- Modern office building
Parking & Commuter Benefits
- Underground parking
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PAION Pharma GmbH 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
PAION Pharma GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein spezialisiertes Pharmaunternehmen im Bereich Anästhesie und Intensivpflege, das innovative Wirkstoffe für den Einsatz bei Patienten in Kliniken und ambulant entwickelt.
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