Formulation Development Leader (m/f/d) – Parenteral Drug Products (100% Full‑Time)
Shape the Future of RNA‑Based Therapeutics.
* Duration: 1-year contract, starting immediately
* Position Type: Temporary placement
* Salary: CHF 69/h to CHF 94/h
About Our Client
For our client, a leading biopharmaceutical company based in Basel, we are seeking an experienced Formulation Development Leader (m/f/d). This innovative organisation is at the forefront of developing next‑generation parenteral therapies, with a strong focus on oligonucleotide‑based platforms and radioligand treatments, dedicated to bringing groundbreaking, life‑changing medicines to patients worldwide.
Your Responsibilities
* Lead formulation development and manufacturing process design for injectable drug products, including solutions, suspensions, and lyophilized formulations.
* Oversee lyophilization cycle development, optimization, and scale‑up activities, utilizing thermal analysis techniques (DSC, FDM, XPRD) and model‑assisted approaches.
* Manage technical documentation such as batch records, experimental designs (DoE), deviation reports, CAPAs, change controls, and regulatory submissions.
* Drive technology transfer activities from development to production sites, ensuring seamless handover to CMOs and internal manufacturing facilities.
* Collaborate cross‑functionally with internal teams, CROs, and external manufacturing partners to advance drug product development with scientific excellence.
* Provide regulatory support by compiling CMC documentation and preparing technical responses to health authorities.
* Apply Quality by Design (QbD) principles to enhance manufacturing processes and ensure product quality.
Your Profile
* Academic background: PhD with 2+ years experience, Master’s with 5+ years, or Bachelor’s with 8+ years of relevant biopharmaceutical industry experience.
* Proven expertise in formulation and process development for parenteral and aseptic drug products, particularly lyophilized dosage forms.
* Strong knowledge of freeze‑drying technologies, including cycle design, development, optimization, and scale‑up from lab to commercial manufacturing.
* Experience with advanced modalities such as RNA‑based therapeutics (siRNA, mRNA), oligonucleotides, or biologics is highly desirable.
* Familiarity with GMP requirements and preparation of regulatory documentation for submissions to health authorities.
* Analytical and problem‑solving skills with hands‑on experience in designing and executing DoE studies.
* Excellent communication abilities in English, both written and verbal, with experience preparing technical reports and regulatory documents.
* Team player with demonstrated ability to collaborate effectively with cross‑functional teams and external partners.
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