Sobi
Global Regulatory CMC Lead(m/w/x)
Full-timeWith HomeofficeSenior
Basel
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RORoche
CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Developing industrialization roadmaps for peptide parenteral drug product launches at a pharmaceutical company. 6+ years in peptide parenteral formulation/process development with NDA authoring experience required. Focus on cutting-edge peptide research and launch strategies.
Requirements
- Ph.D. or master’s degree in chemistry, chemical/process engineering, or related fields
- Minimum of 6 years of industry experience in formulation and process development for peptide parenteral dosage forms
- Proven track record of authoring Drug Product (DP) sections of an NDA for peptide products
- Developing and launching peptide combination products for parenteral use
- Deep expertise in chemistry and solid-state characterization
- Experience in peptide analytical techniques and aseptic manufacturing processes
- Experience in scale-up and technology transfers
- Understanding regulatory and quality requirements
- Direct experience in writing and reviewing regulatory CMC source and submission documents
- Ability to assess program and submission risks from a drug product formulation and manufacturing perspective
- Excellent communication and collaboration skills
- Strong stakeholder management skills
- Ability to think end-to-end and globally
- Proven team player with a problem-solving mindset
- Passion for innovation in the pharmaceutical field
Tasks
- Develop the technical roadmap for industrialization readiness of peptide portfolio
- Advise and coach CMC teams on robust formulation and manufacturing processes
- Manage risks and mitigations for parenteral synthetic molecules portfolio
- Stay updated on advancements in peptide research and formulation science
- Lead scientific strategies and decision-making for development plans
- Mentor staff in preparing and authoring CTA and New Drug Applications
- Collaborate with cross-functional stakeholders to address challenges
Work Experience
- 6 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 Roche 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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RORoche
CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Developing industrialization roadmaps for peptide parenteral drug product launches at a pharmaceutical company. 6+ years in peptide parenteral formulation/process development with NDA authoring experience required. Focus on cutting-edge peptide research and launch strategies.
Requirements
- Ph.D. or master’s degree in chemistry, chemical/process engineering, or related fields
- Minimum of 6 years of industry experience in formulation and process development for peptide parenteral dosage forms
- Proven track record of authoring Drug Product (DP) sections of an NDA for peptide products
- Developing and launching peptide combination products for parenteral use
- Deep expertise in chemistry and solid-state characterization
- Experience in peptide analytical techniques and aseptic manufacturing processes
- Experience in scale-up and technology transfers
- Understanding regulatory and quality requirements
- Direct experience in writing and reviewing regulatory CMC source and submission documents
- Ability to assess program and submission risks from a drug product formulation and manufacturing perspective
- Excellent communication and collaboration skills
- Strong stakeholder management skills
- Ability to think end-to-end and globally
- Proven team player with a problem-solving mindset
- Passion for innovation in the pharmaceutical field
Tasks
- Develop the technical roadmap for industrialization readiness of peptide portfolio
- Advise and coach CMC teams on robust formulation and manufacturing processes
- Manage risks and mitigations for parenteral synthetic molecules portfolio
- Stay updated on advancements in peptide research and formulation science
- Lead scientific strategies and decision-making for development plans
- Mentor staff in preparing and authoring CTA and New Drug Applications
- Collaborate with cross-functional stakeholders to address challenges
Work Experience
- 6 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 Roche 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
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
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