CMC Expert Drug Product Synthetic Molecule Parenterals

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The Pharmaceutical Development DP SM Parenterals group is responsible for the development of parenteral drug products Synthetic molecules from Phase 1 through Launch. Activities encompass formulation and manufacturing process development for all clinical stages and the market , the transfer of product and process to commercial manufacturing sites,as well as line extension development.

We are seeking a seasoned expert to play an anchor role in the development and launch of parenteral peptide formulations, particularly within the Pharmaceutical Development DP SM Parenterals group in Pharma Technical Development (PTD) in Basel. 

The position requires deep scientific expertise and strategic vision to support the drug development portfolio (CMC expertise) and drive innovation within cross-functional teams. 

• Develop the technical roadmap defining activities for industrialization readiness for the peptides portfolio through strategic collaboration with global stakeholders    

• Advise and coach the CMC teams for the development of robust formulations and manufacturing processes managing risks and mitigations for parenteral DP synthetic molecules portfolio ensuring timely delivery of technical activities 

• Stay updated on advancements in peptide research, formulation science, and parenteral drug development to advise on cutting-edge practices.

• Lead scientific strategies and decision-making processes to deliver optimized development and research plans.

• Mentor staff in preparation and authoring of CTA and New Drug Applications (NDAs).

• Collaborate with cross-functional stakeholders to address challenges and ensure success in research and development programs.

• You hold a Ph.D. or master's degree in chemistry, chemical/process engineering, or related fields, with a minimum of 6 years of industry experience in formulation and process development for peptide parenteral dosage forms.

• Proven track record of authoring Drug Product (DP) sections of an NDA for peptide products and developing and launching peptide combination products for parenteral use.

• Deep expertise in chemistry, solid-state characterization, and related scientific fields.

• Experience in peptide analytical techniques, aseptic manufacturing processes, scale-up, technology transfers, and understanding regulatory and quality requirements.

• Direct experience in writing and reviewing regulatory CMC source and submission documents, with a demonstrated ability to assess program and submission risks from a drug product formulation and manufacturing perspective.

• Excellent communication and collaboration skills, with strong stakeholder management and the ability to think end-to-end and globally.

• A proven team player with a problem-solving mindset and a passion for innovation in the pharmaceutical field.

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