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Director of Biologics Development
4 weeks ago
We are seeking a talented individual to join our team as a Director of Biologics Development. This role will be responsible for managing the drug substance and drug product development, manufacturing, scale up, and validation activities of a biologics product at the CDMOs.
The ideal candidate will have a strong background in biologics development and a proven track record of managing complex projects. They will be responsible for providing technical review and approval for manufacturing related documents, verifying suitability, qualification, and validation of processes at CDMOs and other external laboratories, and providing technical support for quality systems governing GMP manufacturing.
The Director of Biologics Development will work closely with colleagues in Technical Operations, Quality, and Regulatory to support the corporate goals for clinical development to commercialization of a biologics drug product for a rare disease indication.
Key responsibilities include:
- Providing technical review and approval for manufacturing related documents
- Verifying suitability, qualification, and validation of processes at CDMOs and other external laboratories
- Providing technical support for quality systems governing GMP manufacturing
- Maintaining up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production
- Authoring and reviewing CMC sections of regulatory submissions
The ideal candidate will have a strong background in biologics development, a proven track record of managing complex projects, and excellent communication and leadership skills.
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range: $Travere will accept applications on an ongoing basis until a candidate is selected for the position.
