Formulation Drug Product Project Leader

vor 3 Wochen

Basel, Schweiz Proclinical Staffing Vollzeit

Drug Product Project Leader – Parenteral Development Proclinical is seeking a dynamic leader to contribute towards innovative technology platforms such as Oligonucleotides and Radioligand Therapies. The successful candidate will play a key role in developing life-changing medicines and driving scientific excellence in formulation and manufacturing processes. Responsibilities Oversee all formulation and manufacturing process deliverables, including scientific documentation, experimental design, batch records, deviations, change controls, CAPAs, tech transfer, and reports. Lead drug product development, manufacturing process transfers, and supply activities with a focus on scientific and technological excellence. Collaborate with internal teams and external partners, including CROs and CMOs, to provide technical input for development and manufacturing processes. Support the preparation of technical regulatory documentation and responses to regulatory agencies. Write and review CMC documentation related to projects or manufacturing changes. Key Skills and Requirements Expertise in developing injectable drugs, including solutions, suspensions, and aseptic formulations. Knowledge of RNA-based therapies (e.g., siRNA, mRNA) and drug delivery systems (e.g., pre-filled syringes, vials). Proficiency in designing and transferring manufacturing processes, with familiarity in aseptic drug manufacturing and Quality by Design (QbD) methods. Experience in lyophilization development, including thermal analysis, cycle design, and scale-up from lab to commercial scale. Understanding of GMP standards and regulatory submission processes. Strong analytical skills for experimental design (e.g., DoE) and data analysis to optimize formulations and processes. Excellent collaboration and communication skills for working with cross-functional teams and external partners. Problem‑solving abilities to address deviations, implement corrective actions, and improve processes. Interest in advancing RNA drug delivery platforms and contributing innovative ideas. If you are having difficulty applying or have any questions, please contact Emile De Beer at e.debeer@proclinical.com. If you are interested in applying to this exciting opportunity, click “Apply” or request a call back at the top of this page. Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. By submitting this application, you confirm that you have read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.proclinical.com/privacy-policy. #J-18808-Ljbffr

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