Biologics Manufacturing Specialist

Vor 2 Tagen


Schaffhausen, Schaffhausen, Schweiz CK Group Vollzeit
Job Title: Biologics Manufacturing Specialist

Location: Switzerland (Hybrid working possible)

Salary and Benefits:

Up to CHF96.90 per hour all-in (8 hours per day) depending on experience

Estimated Annual Salary: Approximately CHF 197,608

Job Description:

As a Biologics Manufacturing Specialist, you will play a key role in the development and implementation of process validation strategies for late-stage biologics/large-molecules DPs.

  • Develop and execute technology transfer strategies for manufacturing processes and equipment.
  • Support the execution of Technology Transfers and Process Performance Qualification (process validation) of large molecule programs.
  • Provide regulatory insight and support to DP leads in delivering qualification of equipment, aseptic process simulation, processing/hold times, and manufacturing processes.
Key Responsibilities:
  • Authoring, reviewing, and approving technical and regulatory documents (e.g., batch records, validation protocols, control strategy, and reports).
  • Supporting DP Process Performance Qualification and preparation of regulatory reports.
  • Supporting internal and external teams in qualification of DP manufacturing equipment.
Requirements:
  • Scientist, MSc or equivalent in a technical field such as Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering.
  • +4 years of experience in biopharmaceuticals or bachelor's degree + 8 years of experience.
  • Expertise in ICH quality guidelines and late-stage biologic DP manufacturing.
  • Filling line experience.
  • Hands-on experience in other areas such as Quality, R&D, and Manufacturing Operation is highly desirable.
  • Experience in technology transfers projects.
Language Requirements:

Fluent in English, with good communication skills in English.

Additional Requirements:

Applicants must hold entitlement to work in Switzerland.



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