Job Summary (Primary function)
The Sr. Director - Executive Director, Biologics CMC Project Management & Operations coordinates phase appropriate biopharmaceutical development and clinical manufacturing activities for the Biologics portfolio. This executive is also responsible for leading the cross-functional portfolio review process with peers and executive management. He/she will define the business processes and facilitate the ensuing governance including project management to functional areas where needed. In addition, this position is responsible for overseeing the technical writers for CMC sections of global dossiers and working with CMC Regulatory Affairs- as the key liaison from the department.
Essential Functions of the Job (Key responsibilities)
- Responsible for driving the development of an end-to-end business process for Technical Operations for Biologics programs. This E2E process will provide the framework for technical governance of all programs ensuring decision making at appropriate levels within the company.
- Facilitate Biologics portfolio review at the executive level across Global Tech Ops functions.
- Lead individual Biologics programs ensuring coordination of development functions with clinical manufacturing, packaging and labeling, quality assurance and regulatory affairs.
- Communicates timelines and decisions effectively throughout the company.
- Ensure multi-disciplinary and comprehensive Gantt Charts are in place for every Biologics Program and manages project teams to meet the project timelines.
- Establish a risk register for all programs including a project dashboard for each project to be reviewed with senior management.
- Manages multiple Biologics CMC Project Management team members and leads multidisciplinary matrix teams. Recruits, develops and retain highs performing Biologics CMC Project Management employees.
- Oversees technical writers for Biologics CMC to deliver sections of global dossiers (using internal and external resources as appropriate) and works with Reg-CMC as the key liaison from the department.
- Responsible for coordinating all activities associated with timely regulatory filings.
- Work with Clinical Program Management and Supply Chain to ensure adequate clinical supplies are available on time.
- Build a team of CMC project managers for Biologics program as required by the portfolio.
- Provide operational support to develop annual budgets.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- MS or PhD in science, engineering or related field. MBA is a plus.
- Must have at least 10 years (Sr. Director) or 15 years (Executive Director) CMC development experience in a Biotechnology or Biopharmaceutical company in a similar position.
- Strong command of phase appropriate regulatory requirements for Biologics.
- Demonstrate track record of success as a CMC project lead in clinical development or life-cycle management.
- Leadership; ability to build trust and create collaborative environment and relationships.
- Effective planning skills; ability to anticipate resources needs and help establish priorities.
- Ability to develop effective, flexible relationships with others; understands the business agendas and perspectives of others; recognizes and effectively balances the interest and needs within the organization.
- Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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