Lead technical product development from start through regulatory approval for all projects, including process optimization, tech transfer, pilot scale development, QbD, scale-up to commercial scale, and process validation.
Author drug product development sections in regulatory submission dossiers. Review, edit, and streamline other CMC sections.
Develop CMC development plans from project initiation to regulatory submission. Develop overall CMC budget for project development life time. Prepare monthly status reports for senior management and local governing bodies.
Lead multidisciplinary CMC teams by working with internal CMC functions and external CDMOs. Represent CMC functions in core project teams to provide updates/escalation to governance bodies.
Evaluate and recommend CDMO selection based on its technical capabilities and quality systems. Provide development milestones and financial commitment input as part of the contract negotiation. Plan, monitor, and track project progress to meet timelines and deliverables. Resolve conflicts. Perform risk management evaluation and develop mitigation strategies.
Post-graduate degree (PhD) in pharmaceutics or related field .e.g. chemical engineering.
Minimum 10 years of experience in the pharmaceutical industry.
Must have experience with product development from concept to commercialization.
In depth understanding of US and EU regulatory CMC requirements and the drug development process.
Proficient with MS Project and other project management tools and methodologies
Deliverable is pharmaceutical product development including clinical trial materials, tech transfer, QbD, process validation and regulatory documentation for filing to obtain successful regulatory approvals.
Strategic U.S. focus and contribution to global organization.
Internal Number: R0008188
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology) and orthopaedics. Ferring’s US operations employ approximately 800 people.
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.