Formulation Development Leader (m/f/d) Parenteral Drug Products 100%

Formulation Development Leader (m/f/d) Parenteral Drug Products

Shape the Future of RNA-Based Therapeutics

• Duration: 1-year contract, starting immediately
• Location: Basel, Switzerland
• 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. As a key player in the global pharmaceutical industry, they are 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, 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

Why Work with Nemensis AG

• Nemensis AG is your specialised personnel recruitment partner in the Life Sciences sector, based in Basel
• Comprehensive consultation and support throughout the entire application process by our experienced consultants
• Access to an extensive client network and exciting opportunities in Northwestern Switzerland
• Fast and uncomplicated onboarding through individual guidance and personalised consulting during the application process

At Nemensis AG, we have already connected thousands of candidates with their dream jobs, giving them the opportunity to develop professionally or re-enter the job market. What can we do for you and your career today? Get in touch with us!

Interested in this Formulation Development Leader (m/f/d) position in Basel? We look forward to receiving your application documents and getting to know you better.

? Phill Rogers, Consultant, Write an email

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