Analytical Method Lead

11 hours ago


Stockholm, Stockholm, Sweden Sobi group Full time

About Sobi Group

Sobi is a global biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. We are committed to developing innovative therapies that make a positive impact on patients' lives.

Job Description

We are seeking a QA Analytical Specialist Lead to take ownership of quality assurance for analytical activities and stability studies. As a key member of our team, you will be responsible for ensuring the quality of analytical methods supporting clinical and commercial use, while also overseeing the implementation of GMP guidelines and regulatory requirements.

Main Responsibilities:

  1. GMP Specialist for Analytical Activities: Ensure the correct implementation of GMP guidelines in QA Analytics processes, including stability studies.
  2. Approving Product Specifications: Review and approve product specifications to ensure compliance with regulatory requirements and Sobi's high standards.
  3. Liaising with Global Regulatory Affairs/CMC: Collaborate with Global Regulatory Affairs/CMC on analytical quality issues, providing strategic support and guidance.
  4. Authoring SOPs and Documentation: Develop, review, and approve Standard Operating Procedures (SOPs) and related documentation to ensure compliance with regulatory requirements and company policies.
Key Skills and Qualifications

To succeed in this role, you will require a strong understanding of regulatory guidelines, method validation, and product specifications. You should have a proven track record of managing deviations, CAPAs, and interactions with external stakeholders. Additionally, you should possess excellent communication skills and be able to collaborate effectively across teams and with external partners.

Required Qualifications:

  • University Degree: A minimum of 4 years in Chemistry, Biology, Biotechnology, or a related field.
  • QA Experience: At least 10 years of QA experience in analytical science within a GMP environment.
  • Strong Understanding of Regulatory Guidelines: A deep understanding of regulatory guidelines, method validation, and product specifications.
  • Excellent Communication Skills: Excellent communication skills, with the ability to collaborate effectively across teams and with external partners.

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