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SO
Sobi
vor 22 Tagen

Senior MSAT Process Manager Small Molecules(m/w/x)

Basel
Vollzeitmit HomeofficeSenior

Beschreibung

In this role, you will ensure the compliant manufacturing of clinical and commercial products by leading process optimization projects and supporting manufacturing activities. Your expertise will guide technical studies, regulatory documentation, and the onboarding of new contract manufacturers.

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Anforderungen

  • •University degree in Chemistry, Biology, Biotechnology, Pharmacy, or related discipline
  • •Minimum 5 years of experience in drug product development and manufacturing
  • •Strong scientific and technical background in CMC development and small molecules non-sterile drug product manufacturing
  • •Proven experience in cross-functional, international environments
  • •Strong organizational and decision-making skills
  • •Good knowledge of relevant regulatory guidelines
  • •Experience interacting with health authorities and preparing regulatory documentation
  • •Fluency in English with strong written and verbal communication skills

Ausbildung

Bachelor-Abschluss

Berufserfahrung

5 Jahre

Aufgaben

  • •Act as a subject matter expert for drug product manufacturing
  • •Lead MSAT projects focused on process optimization
  • •Deliver cost improvements throughout the product lifecycle
  • •Support internal and external manufacturing activities
  • •Manage process changes and major deviations
  • •Conduct risk assessments and CAPA initiatives
  • •Review and approve internal and external SOPs
  • •Contribute to manufacturing instructions
  • •Plan and document technical studies and qualifications
  • •Oversee validation activities
  • •Develop and review product specifications
  • •Contribute to stability programs
  • •Prepare and review sections of APR/PQRs
  • •Assist with regulatory filings and market expansion documentation
  • •Support evaluation and onboarding of new CMOs
  • •Develop quality and supply agreements
  • •Lead technical aspects of product transfers
  • •Oversee scale-up activities and validations
  • •Provide technical oversight of external manufacturing

Sprachen

Englisch – verhandlungssicher

Benefits

Attraktive Vergütung

  • •Competitive compensation

Familienfreundlichkeit

  • •Work/life balance

Lockere Unternehmenskultur

  • •Collaborative environment

Karriere- und Weiterentwicklung

  • •Opportunities for professional growth

Sonstige Vorteile

  • •Diversity and Inclusion

Sinnstiftende Arbeit

  • •Positive impact on patients
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