Position Summary

The Technical Operations CMC Project Management Director is responsible for leading cross-functional teams within Technical Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files. This position is based in Santa Monica, CA and reports to the Head of Technical Operations

Essential Functions and Responsibilities

• Build, grow, and mature the CMC function within Technical Operations.
• Must possess strong communication skills and must be savvy working with technology, process development, analytical development, manufacturing and business partners across the organization in a collaborative way.
• Prepare project team and steering committee materials related to their assigned projects and ensure project work complies with established practices, policies, and processes.
• Project issues and risks must be identified and tracked and plans to resolve these issues must be developed and solutions executed.

Responsibilities

• Lead the strategic planning and execution of CMC programs for cell therapy products from early development through commercialization.
• Collaborate cross-functionally with R&D, Manufacturing, Quality, Regulatory Affairs, and other departments to drive program success and alignment with business objectives.
• Develop and manage program timelines, budgets, and resources to meet project milestones and deliverables.
• Identifies and anticipates CMC-related risks/constraints to timing and resources.
• Provide strategic guidance and oversight for CMC-related regulatory submissions, including IND, BLA, and other regulatory filings.
• Drive continuous improvement initiatives to optimize CMC processes, systems, and workflows.
• Lead and mentor a team of program managers and specialists to ensure high performance, collaboration, and professional development.
• Consistently maintains a positive & professional approach in communication, e.g. maintaining composure under pressure and managing up.
• Foster strong relationships with external partners, vendors, and stakeholders to support program goals and objectives.
• Prepare and present program updates, reports, and strategic recommendations to senior management and key stakeholders.
• Stay informed of industry trends, emerging technologies, and regulatory developments in cell therapy CMC to inform program strategies and decisions.
• Drive continuous improvement initiatives within the CMC project management function to enhance efficiency, productivity, and quality.
• Directs project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.
• Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives.
• Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.

Supervisory Responsibilities

• Provides leadership to the team and functional areas to anticipate and identify complex project issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues and executes corrective actions.
• Selects, evaluates and supports the development of direct reports.

Required Skills/Abilities

• Must have a relevant CMC and knowledge on developing, and manufacturing along with a thorough working knowledge of the Biotech or Cell Therapy industry, relevant regulations, and requirements.
• Experience leading matrix teams in a regulated environment.
• Authored CMC sections of NDA and / or MAA for an NBE
• Thorough understanding of the drug development process.
• Experience in Biotech or Cell Therapy process development and/or product launch preferred.

Education and Experience

• A minimum of BA or BS degree in a technical, engineering or life sciences discipline; an advanced degree in business or in a scientific field is desirable.
• A minimum of ten (10) plus years in pharmaceutical or biotechnology industry with a focus on CMC project management, drug development, manufacturing, or related areas.

The anticipated salary range for candidates who will work in Santa Monica, CA is $170,000 to $201,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

Note: At this time, Neogene is not sponsoring VISAs

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.