Takeda
Associate Director, Drug Product Manufacturing Science & Technology(m/w/x)
Full-timeOn-siteSenior
Zürich, Opfikon
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TATakeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
Zürich, Neuenburg, Oranienburg
Full-timeOn-siteManagement
Nejo AI Summary
Leading small molecule API manufacturing sciences, applying mechanistic modelling for batch/continuous platforms in biopharmaceutical production. Master's in Chemical/Process/Pharm Engineering and 5+ years small-molecule production experience in cGMP required. Work across both batch and continuous manufacturing platforms.
Requirements
- Master's degree in Chemical Engineering, Process Engineering, or Pharmaceutical Engineering
- At least 5 years of experience in cGMP manufacturing environment
- At least 5 years of pharmaceutical industry experience in small-molecule APIs
- Strong foundation in organic/pharmaceutical chemistry and chemical engineering
- In-depth understanding of pharmaceutical manufacturing processes and ICH guidelines
- Experience in mechanistic modelling, process simulation, and data-driven process optimization
- Proven track record leading API process characterization and technology transfer
- Strong problem-solving, project management, and stakeholder management skills
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively in multi-disciplinary teams
- Commitment to sharing knowledge across functions and sites
- Intellectual curiosity about technology and new ways of working
- Willingness to travel to international manufacturing sites
Tasks
- Lead small molecules API manufacturing sciences activities
- Provide process engineering support for batch and continuous API platforms
- Apply mechanistic modelling and process simulation to enhance process understanding
- Characterize API manufacturing processes, including risk assessments
- Define critical process parameters and controls
- Oversee technology transfer of API processes between internal sites and external CMOs
- Ensure compliant implementation of API processes
- Lead API process validation activities, including strategy and protocol design
- Support execution and data evaluation for process validation
- Develop strategies for continuous improvement of marketed API processes
- Optimize yield and improve robustness while reducing cost of goods
- Establish best practices for commercial technology transfer and process validation
- Build and maintain a central knowledge base of API processes
- Share lessons learned across products, sites, and functions
- Collaborate with GMS functions and site leadership
- Provide technical support for marketing applications in global markets
- Prepare responses to regulatory questions from health authorities
- Utilize root cause analysis techniques for process and equipment issues
- Deliver sustainable corrective and preventive actions
- Provide subject matter expertise for due diligence in mergers and acquisitions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda Manufacturing Austria AG 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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TATakeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
Zürich, Neuenburg, Oranienburg
Full-timeOn-siteManagement
Nejo AI Summary
Leading small molecule API manufacturing sciences, applying mechanistic modelling for batch/continuous platforms in biopharmaceutical production. Master's in Chemical/Process/Pharm Engineering and 5+ years small-molecule production experience in cGMP required. Work across both batch and continuous manufacturing platforms.
Requirements
- Master's degree in Chemical Engineering, Process Engineering, or Pharmaceutical Engineering
- At least 5 years of experience in cGMP manufacturing environment
- At least 5 years of pharmaceutical industry experience in small-molecule APIs
- Strong foundation in organic/pharmaceutical chemistry and chemical engineering
- In-depth understanding of pharmaceutical manufacturing processes and ICH guidelines
- Experience in mechanistic modelling, process simulation, and data-driven process optimization
- Proven track record leading API process characterization and technology transfer
- Strong problem-solving, project management, and stakeholder management skills
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively in multi-disciplinary teams
- Commitment to sharing knowledge across functions and sites
- Intellectual curiosity about technology and new ways of working
- Willingness to travel to international manufacturing sites
Tasks
- Lead small molecules API manufacturing sciences activities
- Provide process engineering support for batch and continuous API platforms
- Apply mechanistic modelling and process simulation to enhance process understanding
- Characterize API manufacturing processes, including risk assessments
- Define critical process parameters and controls
- Oversee technology transfer of API processes between internal sites and external CMOs
- Ensure compliant implementation of API processes
- Lead API process validation activities, including strategy and protocol design
- Support execution and data evaluation for process validation
- Develop strategies for continuous improvement of marketed API processes
- Optimize yield and improve robustness while reducing cost of goods
- Establish best practices for commercial technology transfer and process validation
- Build and maintain a central knowledge base of API processes
- Share lessons learned across products, sites, and functions
- Collaborate with GMS functions and site leadership
- Provide technical support for marketing applications in global markets
- Prepare responses to regulatory questions from health authorities
- Utilize root cause analysis techniques for process and equipment issues
- Deliver sustainable corrective and preventive actions
- Provide subject matter expertise for due diligence in mergers and acquisitions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda Manufacturing Austria AG 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Takeda Manufacturing Austria AG
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein weltweit führendes, forschendes biopharmazeutisches Unternehmen, das lebensverbessernde Arzneimittel für komplexe Erkrankungen entwickelt.
Not a perfect match?
- Takeda
Associate Director, Drug Product Manufacturing Science & Technology(m/w/x)
Full-timeOn-siteSeniorZürich, Opfikon - Takeda
Global Manufacturing Sciences BioProcess Lead (Sr. Manager)(m/w/x)
Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
Advanced Process Modeling Expert(m/w/x)
Full-timeOn-siteExperiencedZürich - CSL Behring
Associate Director, Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - SIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Full-timeOn-siteManagementSchlieren