Beschreibung

In this role, you will be at the forefront of developing and launching parenteral peptide formulations, guiding teams through formulation and manufacturing processes while collaborating with global stakeholders to ensure successful outcomes.

Anforderungen

• •Ph.D. or master’s degree in chemistry, chemical/process engineering, or related fields
• •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
• •Developing and launching peptide combination products for parenteral use
• •Deep expertise in chemistry and solid-state characterization
• •Experience in peptide analytical techniques and aseptic manufacturing processes
• •Experience in scale-up and technology transfers
• •Understanding regulatory and quality requirements
• •Direct experience in writing and reviewing regulatory CMC source and submission documents
• •Ability to assess program and submission risks from a drug product formulation and manufacturing perspective
• •Excellent communication and collaboration skills
• •Strong stakeholder management skills
• •Ability to think end-to-end and globally
• •Proven team player with a problem-solving mindset
• •Passion for innovation in the pharmaceutical field

Aufgaben

• •Develop the technical roadmap for industrialization readiness of peptide portfolio
• •Advise and coach CMC teams on robust formulation and manufacturing processes
• •Manage risks and mitigations for parenteral synthetic molecules portfolio
• •Stay updated on advancements in peptide research and formulation science
• •Lead scientific strategies and decision-making for development plans
• •Mentor staff in preparing and authoring CTA and New Drug Applications
• •Collaborate with cross-functional stakeholders to address challenges