The Center for Cancer Cell Therapy (CCT) is seeking a Senior Manager, CMC Operations (Process Development & Manufacturing Professional 4) to provide leadership, oversight and management to on-going manufacturing for novel cell-based therapy for use in Phase I/II clinical trials; provide highly specialized skills to manage and oversee clinical biomanufacturing production consistent with current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases. This role will receive, lead, and manage Technology Transfer projects for IND submissions and cGMP readiness related to cancer therapies. The candidate will have a few direct reports to handle day-to-day logistical operations of technical operations for manufacturing, including liaising with the clinical teams, manufacturing teams, and regulatory group. The CMC Operations, Senior Manager reports to the Associate Director of Process Development & Manufacturing, CCT and plays a critical role in developing the CMC Operations Infrastucture, and managing relationships with internal and external CMOs.

The position will be located at the Laboratory for Cell and Gene Medicine (LCGM), a purpose-build cGMP facility at Stanford School of Medicine that supports cellular therapy process development and manufacturing across diverse clinical specialties.

Learn more about our team here: https://med.stanford.edu/lcgm.html.

Duties include:

• Provide leadership, scientific technical and subject matter expertise to oversee and manage process development and manufacturing activities including planning and implementation of major projects, clinical materials manufacturing activities, process development in translational medicine, services and facilities-related issues.
• Provide scientific leadership across all functional teams by overseeing and directing project development and management and budgeting oversight; collaborating and liaising with clinical investigators; consulting with and driving solutions for major projects with broad, significant clinical impact based on experience and subject matter expertise.
• Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
• May manage two or more staff in day-to-day operations for functional area(s) of responsibility. Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees. Ensure work completion within schedules and constraints.
• Manage the CMC operations for CCT GMP manufacturing with external and internal CMOs, including but not limited to: review of technical documents for accuracy, coordinate logistics for patient samples, inventory clinical materials, liaise with internal groups at Stanford, and author memos and CMC IND sections for our investigator initiated cell therapy trials.
• Support preparation, assembly of clinical, pre-clinical, and CMC information for submissions of Investigational New Drugs (INDs) including amendments, supplements and annual reports for multiple simultaneous submissions for manufactured products across a broad spectrum of biological systems
• Introduce and implement process efficiency tools such as Resource Management, Smartsheet, Lucid Chart, etc. to help improve workflows and communication across the team
• Includes project/submission maintenance; templates; word processing and formatting; proof-reading; bookmarks and hyperlink publishing; and archiving for R&D regulatory documents. This position also executes and maintains processes for managing regulatory submissions, correspondences, and commitments in accordance with Good Documentation Practices. Contribute to installation and maintenance of software for regulatory submissions and documentation
• Liaise with internal teams such as process development scientists, manufacturing scientists, quality control, quality assurance and clinical research staff and operations. Liaise with external teams such as CTF, Clinical Micro/Pathology, LCGM, and adult and pediatric clinical teams.

*- Other duties may also be assigned