The position will be a key strategic leader and member of the executive team, reporting to the CEO. They will have a major impact on RAPT’s later stage development portfolio. They will have demonstrated that they can lead successful late-stage clinical and commercial manufacturing operations.  This is a newly created position and is expected to build and guide the function and our company as we move through our next phases of CMC Development.

 They will be comfortable working in a fast-paced environment where collaboration, flexibility and a patient-centered focus are required.

• Establish the vision and plan for commercial manufacturing at RAPT.
• Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements.
• Accurately predict and to the extent feasible reduce the cost of goods for RAPTs late-stage products.

MAJOR DUTIES AND RESPONSIBILITIES:

• This position will lead a high performing team focused on commercial manufacturing of RAPTs late-stage development candidates.
• Provide a global strategy to validate drug substance and drug product manufacturing processes, to ensure high batch success rates, supporting expansion and growth of future commercial campaigns.
• Oversee the development of the final commercial presentation of drug product for both general and product specific patient populations, i.e., pediatric populations.
• Responsible for maintaining supply quality and timelines, while establishing a robust and resilient commercial supply chain
• Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations.
• Ensures RAPTs manufacturing processes and methods have appropriate IP protections.
• Represent RAPT’s interests to third party manufacturing organizations in negotiating commercial supply contracts that are cost effective, robust and promote high quality commercial manufacturing by leveraging and improving on supply networks already established in earlier clinical development.
• Manage a world-wide supply chain for global markets in the US, Europe and Asia
• Assist in the development of corporate policies as member of executive management team.
• Develops strong internal relationships with others in CMC, Clinical, Regulatory, QA. Legal and Finance to effectively position Commercial Manufacturing at RAPT.

EDUCATION REQUIREMENTS: 

• MS/MA/PhD in Chemistry or related discipline  

EXPERIENCE REQUIREMENTS:

• Previous “ownership” of global product launch at the executive level.
• Previous experience in working through Phase II/III/Commercial
• Proven track record leading the successful global validation and registration and launch of commercial drug substance and drug product manufacturing processes.
• A minimum of 12 years’ experience of related experience in pharmaceutical late-stage development and manufacturing including a minimum of 10 years’ experience in management
• Has a deep understanding of the principles and applications associated with getting ready for commercial manufacturing operations, process control strategy, process robustness, and process engineering for small molecules.
• Previously successfully managed multiple commercial vendors.
• Strongly prefer local bay area candidates. As a member of the leadership team, will need to be in the office 3 days per week.

OTHER QUALIFICATIONS:  

• Track record of success in clinical and commercial production and preparing and defending CMC submissions for FDA and foreign regulatory inspections and approval ideally in a small to mid-size company environment
• Prefer small molecule experience.
• Expertise in regulatory, ICH and legal requirements required for commercial drug manufacturing in countries around the world.
• Experience in leading teams of a dozen or more people.

• This is a hybrid position  (3 days per week on-site at our South San Francisco office).   RAPT is not considering remote candidates for this role. 

CALIFORNIA PAY INFORMATION

California law requires pay information in job postings. The specific rate will depend on the successful candidate’s qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $371,500 (entry-level qualifications) to $383,200 (highly experienced).