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Leading sterile GMP drug product manufacturing transfers from clinical to commercial stages. Aseptic manufacturing know-how for protein drug products, including lyophilization, required. Agile career path, compensation programs recognizing high performance.
Requirements
- Ph.D. or Master in pharmaceutical sciences, engineering, chemistry, or biochemistry
- Significant biotech/pharma industry experience
- Knowledge of drug product technical transfer issues
- Know-how in aseptic product manufacture for protein drug products including lyophilization
- Knowledge of ADCs/highly potent drug product manufacturing highly desirable
- Good leadership and interpersonal skills
- Proven ability as team player
- Ability to manage cross-functional teams
- Very good planning and organizing skills
- Project management skills
- Risk management skills
- Excellent communication skills
- Command of English both written and oral
Tasks
- Ensure activities meet quality, regulatory, and safety standards
- Lead technical transfer for sterile GMP drug product manufacturing
- Manage drug product transfers from clinical to commercial stages
- Define project scope, timelines, risks, and milestones
- Track project progress effectively
- Lead process setup, scale-up, and implementation at GMP sites
- Prepare and maintain technical transfer documentation
- Drive GMP change management
- Handle deviations and CAPAs
- Support regulatory documentation, inspections, audits, and customer interactions
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Compensation programs recognizing high performance
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
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Not a perfect match?
- AbbottFull-timeOn-siteSeniorBasel, Allschwil
- Lonza
Principal Scientist-Analytical Project Leader(m/w/x)
Full-timeOn-siteSeniorBasel - F. Hoffmann-La Roche AG
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Full-timeOn-siteSeniorBasel - Roche
Validation Expert(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - 1201 F. Hoffmann-La Roche AG
Site Transfer and User Team Lead - MSAT KAU(m/w/x)
Full-timeOn-siteSeniorKaiseraugst
Leading sterile GMP drug product manufacturing transfers from clinical to commercial stages. Aseptic manufacturing know-how for protein drug products, including lyophilization, required. Agile career path, compensation programs recognizing high performance.
Requirements
- Ph.D. or Master in pharmaceutical sciences, engineering, chemistry, or biochemistry
- Significant biotech/pharma industry experience
- Knowledge of drug product technical transfer issues
- Know-how in aseptic product manufacture for protein drug products including lyophilization
- Knowledge of ADCs/highly potent drug product manufacturing highly desirable
- Good leadership and interpersonal skills
- Proven ability as team player
- Ability to manage cross-functional teams
- Very good planning and organizing skills
- Project management skills
- Risk management skills
- Excellent communication skills
- Command of English both written and oral
Tasks
- Ensure activities meet quality, regulatory, and safety standards
- Lead technical transfer for sterile GMP drug product manufacturing
- Manage drug product transfers from clinical to commercial stages
- Define project scope, timelines, risks, and milestones
- Track project progress effectively
- Lead process setup, scale-up, and implementation at GMP sites
- Prepare and maintain technical transfer documentation
- Drive GMP change management
- Handle deviations and CAPAs
- Support regulatory documentation, inspections, audits, and customer interactions
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Compensation programs recognizing high performance
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- Abbott
Quality Assurance Manager – Third Party Manufacturing & Technical Transfer(m/w/x)
Full-timeOn-siteSeniorBasel, Allschwil - Lonza
Principal Scientist-Analytical Project Leader(m/w/x)
Full-timeOn-siteSeniorBasel - F. Hoffmann-La Roche AG
Drug Product Technology Strategy Project Leader(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Validation Expert(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - 1201 F. Hoffmann-La Roche AG
Site Transfer and User Team Lead - MSAT KAU(m/w/x)
Full-timeOn-siteSeniorKaiseraugst