Director/Senior Director

Who we are looking for:

Vor Bio is seeking an exceptional and highly motivated CMC leader Director/Sr Director Regulatory CMC to join our team. The qualified candidate will work cross-functionally to lead development and implementation of robust regulatory CMC strategies & tactics across programs and lifecycle stages to support our company objectives. As a result, the candidate will play a vital role in helping to progress our cell and genome engineered products to registration for the treatment of hematological malignancies and rare diseases.

The candidate must be a highly effective leader as they will be relied upon to drive robust CMC strategic plans throughout development. This individual should also have strong interpersonal skills and a demonstrated track record with regulatory agencies.

Extensive experience in the development of cell therapy products with direct interactions with the FDA’s Center for Biologics and OTP as desirable.

Key areas of responsibility:

• As a member of the CMC project teams, act as Regulatory CMC Lead for assigned programs providing strategic guidance to development team(s) on complex regulatory CMC topics.
• Responsible for leading negotiations with regulators as applicable for initial INDs/CTAs, amendments and future marketing registration applications.
• Accountable to establish and execute high-quality CMC related submissions including INDs/CTAs or amendments working in collaboration with other stakeholders (ie., research process & analytical development, manufacturing, and other SME’s).
• Keep abreast of and communicate CMC regulatory requirements to ensure all development activities follow applicable regulations and guidelines.
• Provide regulatory strategic and tactical support for CMC aspects such as change control & inspection management. Assess proposed manufacturing process changes, provide expertise on raw materials management, DP/DS specifications and release, process characterization & validation, methods development & validation and provide strategic regulatory guidance to enable implementation.
• Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance and integrate into program plans.
• Maintain responsibility for all CMC Regulatory timelines, that also includes managing contract staff and vendors relevant to CMC activities.
• Build and maintain strong relationships with internal and external stakeholders.

Qualifications: 

• PharmD or PhD preferred with ≥8 years of industry experience in Regulatory CMC biologics. Experience working in cell therapies is preferred. A strong scientific background and training in cell and tissue biology is a plus.
• A strong background & track record in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of cell therapy/biologics.
• A broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution in US/ex-US.
• Experience interfacing with FDA, and other regulatory agencies within the pharmaceutical industry.
• Demonstrated risk identification and critical thinking skills.
• Strong understanding of the global pharmaceutical drug development and regulatory environment, including anticipating future trends and opportunities in cell therapy
• Ability to interact effectively across all levels of the organizations; integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives.
• Recognized as an influential leader who possesses a cross-functional collaborative skill set.
• Excellent oral and written communication skills with strong attention to detail and the ability to coordinate multiple activities in a faced paced biotech environment.