Novartis Pharma AG
Analytical Project Leader(m/w/x)
Full-timeOn-siteSenior
Basel
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IDIdorsia Pharmaceuticals Ltd
Analytical Project Manager(m/w/x)
Basel
Full-timeOn-siteExperienced
Nejo AI Summary
Developing and optimizing analytical methods for drug substances and products, including purity and genotoxic impurity determinations. Project management experience with CMOs/CROs and GMP knowledge required. Focus on small-molecule drugs for insomnia treatments.
Requirements
- College/university degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering
- 10+ years BS, 7+ years MS, or 2+ years PhD experience in pharmaceutical industry
- Demonstrated previous success in project management
- Good knowledge of GMP regulations
- Good knowledge of regulatory requirements for Drug Substances and Drug Products development
- Broad knowledge in analytical chemistry
- Sound knowledge in synthetic chemistry
- Sound knowledge in drug substance processing
- Sound knowledge in formulation development
- Sound knowledge in pharmaceutical processing
- Experience in development of analytical tests for drug substances and products
- Experience in performance of analytical tests for drug substances and products
- Experience in international environments
- Experience in cross-cultural environments
- Excellent written communication skills
- Excellent verbal communication skills
- Excellent listening skills
- Excellent problem-solving ability
- Ability to measure and manage risk(s)
- Effective negotiation capabilities
- Effective influencing capabilities
- Reliability
- Conscientiousness
- Adaptability
- Ability to work independently
- Ability to work collaboratively in a matrixed environment
Tasks
- Develop state-of-the-art analytical methods for new drug substances and products
- Manage a portfolio of 2-4 projects based on their lifecycle
- Oversee analytical projects with CMOs and CROs
- Optimize and implement analytical methods for purity, stability, cleaning verification, excipients, content, and genotoxic impurity determinations
- Write and compile documents for method implementation
- Represent AD/QC in technical project and product team meetings
- Document all analytical activities according to Good Documentation Practices
- Review and approve analytical data and results
- Write, review, and approve analytical protocols and reports
- Establish and maintain analytical equipment according to GMP
- Draft and review CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs
- Organize GMP (re)qualification and validation of analytical equipment with external companies
- Design and execute projects or experiments independently
- Review scientific work in project-related activities
- Evaluate and develop novel analytical techniques and instrumentation
- Prepare source documents for IND, IMPD, and NDA/MA submissions
- Respond to agency questions and interact with Health Authorities
- Review CMC sections for IND/IMPD and NDA/MAA filings
- Participate in technology transfer between internal and external laboratories
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- HPLC-UV
- HPLC-MS
- GC-MS
- NMR
- Spectroscopy
- wet chemistry
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd 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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IDIdorsia Pharmaceuticals Ltd
Analytical Project Manager(m/w/x)
Basel
Full-timeOn-siteExperienced
Nejo AI Summary
Developing and optimizing analytical methods for drug substances and products, including purity and genotoxic impurity determinations. Project management experience with CMOs/CROs and GMP knowledge required. Focus on small-molecule drugs for insomnia treatments.
Requirements
- College/university degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering
- 10+ years BS, 7+ years MS, or 2+ years PhD experience in pharmaceutical industry
- Demonstrated previous success in project management
- Good knowledge of GMP regulations
- Good knowledge of regulatory requirements for Drug Substances and Drug Products development
- Broad knowledge in analytical chemistry
- Sound knowledge in synthetic chemistry
- Sound knowledge in drug substance processing
- Sound knowledge in formulation development
- Sound knowledge in pharmaceutical processing
- Experience in development of analytical tests for drug substances and products
- Experience in performance of analytical tests for drug substances and products
- Experience in international environments
- Experience in cross-cultural environments
- Excellent written communication skills
- Excellent verbal communication skills
- Excellent listening skills
- Excellent problem-solving ability
- Ability to measure and manage risk(s)
- Effective negotiation capabilities
- Effective influencing capabilities
- Reliability
- Conscientiousness
- Adaptability
- Ability to work independently
- Ability to work collaboratively in a matrixed environment
Tasks
- Develop state-of-the-art analytical methods for new drug substances and products
- Manage a portfolio of 2-4 projects based on their lifecycle
- Oversee analytical projects with CMOs and CROs
- Optimize and implement analytical methods for purity, stability, cleaning verification, excipients, content, and genotoxic impurity determinations
- Write and compile documents for method implementation
- Represent AD/QC in technical project and product team meetings
- Document all analytical activities according to Good Documentation Practices
- Review and approve analytical data and results
- Write, review, and approve analytical protocols and reports
- Establish and maintain analytical equipment according to GMP
- Draft and review CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs
- Organize GMP (re)qualification and validation of analytical equipment with external companies
- Design and execute projects or experiments independently
- Review scientific work in project-related activities
- Evaluate and develop novel analytical techniques and instrumentation
- Prepare source documents for IND, IMPD, and NDA/MA submissions
- Respond to agency questions and interact with Health Authorities
- Review CMC sections for IND/IMPD and NDA/MAA filings
- Participate in technology transfer between internal and external laboratories
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- HPLC-UV
- HPLC-MS
- GC-MS
- NMR
- Spectroscopy
- wet chemistry
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd 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
Idorsia Pharmaceuticals Ltd
Industry
Pharmaceuticals
Description
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Not a perfect match?
- Novartis Pharma AG
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