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Senior Manager, Drug Substance MSAT(m/w/x)
MSAT technical expertise for drug substance therapies, overseeing product launch and tech transfer for geographic atrophy treatments. Extensive cGMP development and manufacturing experience, with proven MSAT track record, required. Summer and winter shutdowns, paid family leave.
Requirements
- Bachelor’s degree in life sciences or engineering
- Extensive experience in cGMP development and manufacturing
- Deep knowledge of pharmaceutical processes and technologies
- Proven track record in MSAT or related fields
- Experience in process validation and lifecycle management
- Familiarity with CTD Module 3 authorship and regulatory standards
- Expertise in at least two modalities (e.g., peptides, oligonucleotides, biologics)
- Strong attention to detail and hands-on project management
- Excellent technical, communication, problem-solving, and organizational skills
- Effective team player with ability to build strong relationships
- Valid passport and ability to travel
- Eligibility to work in Switzerland
Tasks
- Serve as MSAT technical expert on projects
- Oversee product launch and tech transfer
- Conduct process characterization and validation
- Support risk management and troubleshooting
- Manage development and manufacturing activities
- Lead technical transfer and lifecycle planning
- Proactively resolve technical challenges and deviations
- Ensure qualification and validation of processes and equipment
- Collaborate with cross-functional teams for tech transfer
- Build relationships with development and manufacturing partners
- Confirm equipment qualification during process validation
- Identify opportunities for continuous process improvement
- Support evaluation of major deviations and root cause analysis
- Apply risk management tools throughout lifecycle management
- Develop data management processes for operational analysis
- Contribute to writing and reviewing regulatory submission sections
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Other Benefits
- Comprehensive benefits package
Flexible Working
- Flexible time off
More Vacation Days
- Summer and winter shutdowns
Generous Parental Leave
- Paid family leave
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Senior Manager, Drug Substance MSAT(m/w/x)
MSAT technical expertise for drug substance therapies, overseeing product launch and tech transfer for geographic atrophy treatments. Extensive cGMP development and manufacturing experience, with proven MSAT track record, required. Summer and winter shutdowns, paid family leave.
Requirements
- Bachelor’s degree in life sciences or engineering
- Extensive experience in cGMP development and manufacturing
- Deep knowledge of pharmaceutical processes and technologies
- Proven track record in MSAT or related fields
- Experience in process validation and lifecycle management
- Familiarity with CTD Module 3 authorship and regulatory standards
- Expertise in at least two modalities (e.g., peptides, oligonucleotides, biologics)
- Strong attention to detail and hands-on project management
- Excellent technical, communication, problem-solving, and organizational skills
- Effective team player with ability to build strong relationships
- Valid passport and ability to travel
- Eligibility to work in Switzerland
Tasks
- Serve as MSAT technical expert on projects
- Oversee product launch and tech transfer
- Conduct process characterization and validation
- Support risk management and troubleshooting
- Manage development and manufacturing activities
- Lead technical transfer and lifecycle planning
- Proactively resolve technical challenges and deviations
- Ensure qualification and validation of processes and equipment
- Collaborate with cross-functional teams for tech transfer
- Build relationships with development and manufacturing partners
- Confirm equipment qualification during process validation
- Identify opportunities for continuous process improvement
- Support evaluation of major deviations and root cause analysis
- Apply risk management tools throughout lifecycle management
- Develop data management processes for operational analysis
- Contribute to writing and reviewing regulatory submission sections
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Other Benefits
- Comprehensive benefits package
Flexible Working
- Flexible time off
More Vacation Days
- Summer and winter shutdowns
Generous Parental Leave
- Paid family leave
About the Company
Apellis Pharmaceuticals, Inc.
Industry
Pharmaceuticals
Description
The company develops life-changing therapies for challenging diseases, including the first therapy for geographic atrophy.
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