Bayer
Computational Designer - Biologics & Peptides (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Wuppertal, Berlin
ab 104.300 - 126.500 / Jahr
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BABayer
Senior Principal Peptide Scientist - External API Development (m/w/x)
Vollzeitmit HomeofficeSenior
Green Job
Nejo KI-Zusammenfassung
External API development for peptide drug substances, including synthetic routes and manufacturing processes via CDMO network. Expertise in peptide synthesis technologies and API process development required. Hybrid work, childcare support.
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Anforderungen
- PhD in organic chemistry, medicinal chemistry, peptide chemistry, pharmaceutical sciences, or related discipline
- Expertise in peptide drug substance development and manufacturing
- Expertise in solid-phase, liquid-phase, hybrid, fragment-based, and emerging synthesis technologies
- Hands-on API process development, scale-up, manufacturing, and troubleshooting
- Experience within an external CDMO model
- Solid understanding of phase-appropriate CMC requirements
- Experience in CMC strategy development, risk assessment, planning, and documentation
- Building process understanding for impurities, purification, isolation, and stability
- Contributing to control strategy concepts for impurities, purification, isolation, and stability
- Clear communication and stakeholder management in global, cross-functional projects
- Pragmatic decision-making in project environments
- Strong quality, regulatory, safety, sustainability, and data integrity mindset
- Fluent English (written and spoken)
Aufgaben
- Define and deliver phase-appropriate drug substance strategies
- Define and deliver synthetic routes
- Define and deliver manufacturing processes
- Define and deliver supply solutions through external CDMO network
- Represent Drug Substance Chemistry within the global CMC Technical Development team
- Lead the design, evaluation, and optimization of synthetic routes
- Lead the design, evaluation, and optimization of manufacturing processes for peptide APIs
- Define phase-appropriate drug substance strategies
- Select suitable peptide synthesis approaches
- Select suitable peptide purification approaches
- Select suitable peptide isolation approaches
- Select suitable peptide manufacturing approaches
- Provide scientific expertise on protecting-group strategies
- Provide scientific expertise on coupling and deprotection
- Provide scientific expertise on aggregation
- Provide scientific expertise on epimerization
- Provide scientific expertise on oxidation
- Provide scientific expertise on impurity formation
- Provide scientific expertise on purification
- Provide scientific expertise on isolation
- Provide scientific expertise on stability
- Translate discovery-scale chemistry into reproducible, scalable, phase-appropriate processes
- Translate SAR-driven chemistry into reproducible, scalable, phase-appropriate processes
- Represent Drug Substance Chemistry in cross-functional CMC project teams
- Contribute to CMC strategy
- Contribute to risk assessment
- Contribute to development planning
- Contribute to supply planning
- Contribute to regulatory documentation
- Steer route design proposals from external partners
- Challenge route design proposals from external partners
- Approve route design proposals from external partners
- Steer process development proposals from external partners
- Challenge process development proposals from external partners
- Approve process development proposals from external partners
- Steer scale-up proposals from external partners
- Challenge scale-up proposals from external partners
- Approve scale-up proposals from external partners
- Steer manufacturing proposals from external partners
- Challenge manufacturing proposals from external partners
- Approve manufacturing proposals from external partners
- Oversee external development campaigns for toxicology studies
- Oversee external manufacturing campaigns for toxicology studies
- Oversee external development campaigns for clinical trials
- Oversee external manufacturing campaigns for clinical trials
- Oversee external development campaigns for registration
- Oversee external manufacturing campaigns for registration
- Oversee external development campaigns for launch
- Oversee external manufacturing campaigns for launch
- Oversee external development campaigns for commercial supply
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – fließend
Benefits
Flexibles Arbeiten
- Hybrid work models
- Part-time arrangements
- Flexible work arrangements
Kinderbetreuung
- Company daycare centers
- Childcare support
- Summer camps for children
Familienfreundlichkeit
- Time off for family care
Weiterbildungsangebote
- Learning and development opportunities
- Training programs
Mentoring & Coaching
- Development dialogues
- Coaching programs
- Mentoring programs
Gesundheits- & Fitnessangebote
- Health awareness promotion
- Free health checks
Mentale Gesundheitsförderung
- Self-care opportunities
Lockere Unternehmenskultur
- Inclusive work environment
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PharmaceuticalsWuppertal
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