Assoc. Scientist

Vor 2 Tagen


Basel, Schweiz TN Switzerland Vollzeit

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Assoc. Scientist - Technical Development, BaselClient:

Proclinical

Location:

Basel

Job Category:

Other

Job Reference:

d42ea44f8cfb

Job Views:

7

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Proclinical is seeking a Quality Control Specialist to support the release and stability strategy, method validation, and transfer activities for biologics. The successful candidate will manage GMP testing operations for clinical drug substances and products, ensuring documentation meets timelines and standards.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  1. Deliver work packages for GMP testing of biologics for release, stability, validation, and transfer.
  2. Author and review technical documents for global submissions.
  3. Review CMC documentation for health authority submissions.
  4. Conduct instrument qualification and decommissioning as a System Owner.
  5. Support shipment desk as a Sample Management Officer.

Key Skills and Requirements:

  1. Strong planning, organizational, problem-solving, and interpersonal skills.
  2. Effective communication with a collaborative, patient-focused approach.
  3. Proficient in computer and IT systems.
  4. Science degree in Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology, or equivalent.
  5. Experience in Quality Control within a GMP environment or pharmaceutical industry.
  6. Technical and scientific knowledge of pharmaceutical development and analytical sciences.
  7. Understanding of health authority regulations.
  8. Ability to critically evaluate data from various scientific disciplines.
  9. Proficient in English; additional languages are a plus.
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