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Sobi
23d ago

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

Basel
Full-timeWith Home OfficeSenior

Description

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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Requirements

  • •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

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • •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

Languages

English – Business Fluent

Benefits

Competitive Pay

  • •Competitive compensation

Family Support

  • •Work/life balance

Informal Culture

  • •Collaborative environment

Career Advancement

  • •Opportunities for professional growth

Other Benefits

  • •Diversity and Inclusion

Purpose-Driven Work

  • •Positive impact on patients
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