Senior Director Biologics CMC Project Leadership

Welcome to AstraZeneca, a leading global pharmaceutical company dedicated to improving the lives of patients through innovative and life-changing medicines. We are seeking a highly experienced Senior Director of Biologics CMC Project Leadership to join our team and drive the successful development and commercialization of our biologics portfolio.In this role, you will be responsible for providing strategic and operational leadership for all aspects of biologics CMC project management, including drug substance and drug product development, manufacturing, and regulatory submissions. You will collaborate closely with cross-functional teams and external partners to ensure timely and efficient delivery of high-quality biologics products.To excel in this position, you must have a deep understanding of biologics development and manufacturing processes, as well as a proven track record of successfully leading and delivering complex projects in the pharmaceutical industry. Your strong leadership, communication, and problem-solving skills will be crucial in navigating challenges and driving progress towards our goal of delivering life-changing medicines to patients in need.Join us in our mission to make a difference in the world of biologics and be a part of our dynamic and innovative team at AstraZeneca.

1. Develop and implement strategic plans for the successful development and commercialization of biologics products, in alignment with company goals and objectives.
2. Provide leadership and direction to the biologics CMC project team, ensuring effective collaboration and communication across all functions and external partners.
3. Oversee the planning, execution, and tracking of all biologics CMC project activities, including drug substance and drug product development, manufacturing, and regulatory submissions.
4. Ensure timely and efficient delivery of high-quality biologics products, meeting all project milestones and budget targets.
5. Identify and mitigate risks and issues that may impact project timelines, budget, or quality, and develop contingency plans as needed.
6. Foster a culture of continuous improvement, driving innovation and efficiency in biologics project management processes.
7. Build and maintain strong relationships with internal and external stakeholders, including key opinion leaders, regulatory agencies, and CROs/CMOs.
8. Keep abreast of industry trends, regulatory updates, and new technologies in biologics development and manufacturing, and apply this knowledge to drive project success.
9. Provide regular project updates and reports to senior management, highlighting progress, challenges, and recommendations for improvement.
10. Mentor and develop team members, providing guidance and support to ensure their professional growth and success.
11. Adhere to all company policies and procedures, as well as regulatory requirements, to ensure compliance and ethical conduct in all aspects of work.
12. Represent the company at conferences, meetings, and other events related to biologics development and project management.
13. Continuously monitor and evaluate the competitive landscape, identifying opportunities for collaboration and partnership to enhance the company's biologics portfolio.
14. Demonstrate a strong commitment to the company's mission and values, and actively promote a positive and inclusive work culture within the team and across the organization.

According to JobzMall, the average salary range for a Senior Director Biologics CMC Project Leadership in Gaithersburg, MD, USA is $180,000 - $250,000 per year. This range can vary depending on factors such as experience, education, and the specific company or organization the individual is working for.

AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company.