dormakaba International Holding
Global Communication Specialist (m/w/x)
Vollzeitnur vor OrtSenior
Ennepetal
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Dein persönlicher KI-Karriere-Agent
BABayer
Senior Principal Scientist - External API Development for New Chemical Entities (m/w/x)
VollzeitVor OrtSenior
Green Job
Nejo KI-Zusammenfassung
Designing synthetic routes for new chemical entities and partnering with external CDMOs. Ph.D. in Chemistry and extensive pharmaceutical industry experience required. Company daycare centers, childcare finding support, and time off for family care.
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Anforderungen
- Ph.D. in Chemistry or related science
- Extensive pharmaceutical industry experience
- Understanding of GLP/GMP and regulatory expectations
- Strong synthetic chemistry background
- Excellent understanding of reagents, methodologies, reaction mechanisms
- Solid grasp of analytical techniques
- Experience in CMC development of peptides (plus)
- Experience steering external partners (CROs/CDMOs)
- Experience working across external manufacturing network
- Ability to represent chemistry and Drug Substance in interdisciplinary teams
- Accountable interface between internal and external partners
- Strategic thinking ability
- Innovative thinking ability
- Develop and analyze multiple solutions to complex chemistry problems
- Challenge the status quo
- Strong communication skills
- Strong project management skills
- Assertiveness
- Service orientation
- Enjoyment of cross-functional teamwork
- Fluency in English (negotiation level)
- German is an asset
- Willingness to learn German
Aufgaben
- Design, develop, and enable synthetic routes for new chemical entities
- Partner with external CDMO network to evolve synthetic routes into manufacturing processes
- Define and drive Drug Substance (DS) strategy within global CMC teams
- Accountable for DS contribution to the overall CMC package
- Lead chemical process development and API supply activities
- Enable phase-appropriate, scalable, and sustainable manufacturing processes
- Ensure timely API delivery, robust product quality, and cost efficiency
- Provide scientific leadership for design, assessment, and optimization of synthetic routes
- Focus on speed, quality, cost, sustainability, and process understanding for synthetic routes
- Represent Drug Substance (DS) in global CMC development project teams
- Contribute to key scientific, strategic, and portfolio decisions
- Ensure coherent two-way flow of strategy, decisions, risks, and progress between internal and external teams
- Guide and challenge route design and synthetic methodology choices at external CDMOs
- Translate SAR-driven chemistry into scalable routes for supply and future production
- Align synthetic routes with internal DS development strategy
- Oversee external API campaigns for toxicology studies and clinical trials
- Manage planning, risk assessment, and supply-demand alignment for API campaigns
- Provide budget oversight for API campaigns
- Steer process transfers between external partners and into internal or external manufacturing
- Ensure knowledge continuity and phase-appropriate documentation during process transfers
- Contribute to robust, phase-appropriate control strategies
- Co-author and review Drug Substance sections of regulatory filings
- Support responses to health authority questions
- Provide CMC DS assessments for in-licensing opportunities
- Provide chemical expertise and pragmatic troubleshooting across the manufacturing network
- Share knowledge and drive innovation across organizational boundaries
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
Benefits
Kinderbetreuung
- Company daycare centers
- Childcare finding 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 checks
Lockere Unternehmenskultur
- Inclusive work environment
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Bayer erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei BayerÜber das Unternehmen
BA
PharmaceuticalsWuppertal
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