ABOUT THE JOB:
We are looking for a Stability Studies Senior Specialist to join our R&D Department. The selected candidate will lead and coordinate Stability Studies activities, ensuring the proper planning, execution, review and documentation of stability studies for allergy immunotherapy pharmaceutical products, in compliance with regulatory requirements, GMP standards and the strategic objectives of the department.
The position will report to the R&D Section Manager and will work closely with cross-functional teams within the organization.
Mission:
Lead and coordinate the Stability Studies area within the R&D Department, ensuring the correct execution, monitoring and documentation of stability studies for pharmaceutical products and associated materials, guaranteeing compliance with GMP regulations, ICH guidelines and internal quality standards.
Main Tasks and Responsibilities:
- Coordinate and supervise the execution of stability studies for pharmaceutical products and associated materials.
- Plan Stability Studies activities according to project timelines and priorities established by the Section Manager and R&D Management.
- Manage the review and approval of protocols, technical reports and related documentation.
- Ensure compliance with GMP regulations, ICH stability guidelines and internal procedures.
- Supervise the management of stability chambers, sample inventories, study schedules and analytical follow-up activities.
- Evaluate analytical trends, study results and potential deviations related to product stability.
- Lead investigations related to incidents, deviations, OOS results and CAPA actions within the Stability area.
- Coordinate the technical activities of analysts and laboratory technicians.
- Participate in development projects, analytical validations and analytical method transfers related to stability studies.
- Collaborate closely with Analytical Development, Production, Quality Assurance and Regulatory Affairs departments.
- Prepare technical documentation for audits, regulatory inspections and registration dossiers.
- Propose continuous improvements in processes, organization and operational efficiency within the area.
- Participate in the definition of technical objectives and strategy for the R&D section.
Requirements:
Academic Background:
- PhD and/or University Degree in Pharmacy, Chemistry, Biotechnology, Biology or related disciplines.
- A specialized Master’s degree and relevant experience within the pharmaceutical industry will be considered an asset.
- Additional training in Pharmaceutical Quality Systems or Project Management is desirable.
Professional Experience:
- Minimum of 5 years of previous experience in Quality Control, Analytical Development or Stability Studies laboratories within the pharmaceutical industry.
- Experience coordinating activities or supervising technical teams.
- Experience with biological products, immunotherapy products or sterile pharmaceuticals will be highly valued.
Technical Knowledge:
- Advanced knowledge of GMP regulations and ICH stability guidelines.
- Experience in writing and reviewing protocols, technical reports and regulated documentation.
- Knowledge of analytical techniques and regulated document management systems.
- Experience working with LIMS, statistical software and document management tools.
- Advanced English level (C1).
- Fluent German (B2 or higher) will be considered an asset.
Competencies:
- Leadership and team coordination skills.
- Strong analytical mindset and results-oriented approach.
- Excellent organizational and planning skills.
- High level of technical writing and document review capabilities.
- Strong quality and compliance mindset.
- Excellent communication and cross-functional collaboration skills.
Observations:
We are looking for a proactive, highly organized and quality-oriented professional, capable of working in multidisciplinary environments and contributing to the continuous improvement of R&D processes within a highly regulated pharmaceutical environment.
