ABOUT THE JOB:
We are looking for a Senior Specialist in Stability Studies to join our R&D Department. The selected candidate will lead and coordinate stability studies, 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 department’s strategic objectives.
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 proper execution, monitoring, and documentation of stability studies for pharmaceutical products and related materials, and guaranteeing compliance with GMP regulations, ICH guidelines, and internal quality standards.
Main Tasks and Responsibilities:
- Coordinate and supervise the conduct of stability studies for pharmaceutical products and related materials.
- Plan Stability Studies activities in accordance with the 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.
- Oversee 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, out-of-specification (OOS) results, and corrective and preventive actions (CAPA) 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.
- Work closely with the 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 department.
- Help define the technical objectives and strategy for the R&D department.
Requirements:
Academic Background:
- PhD and/or a university degree in pharmacy, chemistry, biotechnology, biology, or related fields.
- A specialized master’s degree and relevant experience in the pharmaceutical industry will be considered an asset.
- Additional training in pharmaceutical quality systems or project management is preferred.
Professional Experience:
- At least 5 years of prior 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 regulatory documentation.
- Knowledge of analytical techniques and regulated document management systems.
- Experience working with LIMS, statistical software, and document management tools.
- Advanced English level (C1).
- Fluency in German (B2 or higher) is a plus.
Competencies:
- Leadership and team coordination skills.
- Strong analytical skills and a results-oriented approach.
- Excellent organizational and planning skills.
- High level of technical writing and document review skills.
- A strong focus on quality and compliance.
- Excellent communication and cross-functional collaboration skills.
Notes:
We are looking for a proactive, highly organized, and quality-oriented professional who is capable of working in multidisciplinary environments and contributing to the continuous improvement of R&D processes within a highly regulated pharmaceutical setting.
