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Sobi
5d ago

Senior Process Manager MSAT(m/w/x)

Basel
Full-timeWith Home OfficeSenior

Description

In this pivotal role, you will ensure reliable manufacturing by leading technical projects and product transfers while driving process innovations across the company's clinical and commercial portfolio.

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Requirements

  • •University degree in Chemistry, Biology, Biotechnology, Pharmacy, or related field
  • •At least 5 years of experience in drug product development and manufacturing
  • •Scientific and technical expertise in CMC development and aseptic manufacturing
  • •Expert status in aseptic drug product manufacturing
  • •Experience in cross-functional teams and decision-making skills
  • •Knowledge of regulatory guidelines and documentation proficiency
  • •Fluency in English with excellent communication skills

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • •Serve as the subject matter expert for drug product manufacturing and validation
  • •Lead MSAT projects focused on process and cost improvements
  • •Manage process changes, major deviations, and risk assessments
  • •Issue and approve internal and external manufacturing instructions
  • •Oversee technical studies, qualifications, and validation documentation
  • •Develop new product specifications and stability programs
  • •Write regulatory registration files and market expansion documents
  • •Evaluate and onboard new contract manufacturing partners
  • •Develop supply and quality agreements for external partners
  • •Lead technical product transfers and scale-up activities
  • •Introduce innovative technologies to enhance process yield and efficiency

Tools & Technologies

CMC developmentAseptic drug product manufacturing

Languages

English – Business Fluent

Benefits

Competitive Pay

  • •Competitive compensation

Family Support

  • •Emphasis on work/life balance

Informal Culture

  • •Collaborative team-oriented environment

Career Advancement

  • •Professional growth opportunities

Other Benefits

  • •Diversity and Inclusion

Purpose-Driven Work

  • •Meaningful work
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