Scientist Stability (m/f/d) – Hybrid Role

Job description

Stability testing, Drug Substance/Product, 7-Months contract Exciting Opportunity in a Global Pharmaceutical Environment For our client, a leading international biopharmaceutical company, we are currently looking for a motivated and experienced Scientist Stability to join the Global Biopharmaceutical Stability team. In this role, you will be responsible for stability strategies and oversight of commercial Drug Substance and Drug Product stability programs within a highly collaborative global environment. Your Responsibilities Act as Stability Product Lead for assigned commercial products Develop, maintain, and oversee stability strategies and stability programs in accordance with ICH guidelines and regulatory requirements Evaluate, interpret, and trend stability data to assess product quality, shelf life, and regulatory compliance Author, review, and approve stability protocols, reports, scientific justifications, and technical documentation Support regulatory submissions including CTD dossiers, annual reports, product renewals, and health authority responses Lead or support OOT/OOS investigations, root cause analyses, CAPAs, and other quality-related activities Participate in product transfers and perform gap assessments against global regulatory and quality requirements Coordinate annual commercial stability programs with sample management and QC teams Collaborate with cross-functional international teams including Quality, Regulatory Affairs, Manufacturing, and Analytical Sciences Support health authority inspections and audits as Subject Matter Expert for stability-related topics Contribute to Operational Excellence initiatives to improve and standardize stability processes Your Profile Bachelor’s, Master’s, or PhD degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline Minimum 3–5 years of experience in the pharmaceutical industry Demonstrated experience managing or supporting Drug Substance and/or Drug Product stability programs Strong knowledge of ICH Stability Guidelines (Q1A–Q1E, Q5C) and cGMP requirements Proven ability to evaluate and interpret stability and QC data, identify trends, and draw scientifically sound conclusions Experience with investigations, including OOT/OOS events, deviations, root cause analysis, and CAPA management Experience authoring scientific, technical, and regulatory documentation within a GMP environment Good understanding of pharmaceutical quality systems and regulatory expectations Familiarity with statistical software such as JMP or SlimSTAT is an advantage Experience with LIMS and Quality Management Systems (e.g., TrackWise or Veeva) Strong analytical thinking, scientific rigor, and attention to detail Ability to work independently and effectively within a global matrix organization Excellent communication skills in French and English Key Success Factors We are particularly interested in candidates who can demonstrate: Hands-on experience with pharmaceutical stability programs Strong scientific judgement in the interpretation of stability and analytical data Solid understanding of regulatory and quality requirements Experience managing investigations and technical problem-solving activities Confidence in preparing and reviewing regulatory and scientific documentation