Operations Director jobs in the United States

Product Champion Director, GTO

Location: Gaithersburg, MD (minimum 3x days a week onsite)

Overview:

Do you have a passion for manufacturing, developing, and commercializing life-changing medicines in a patient-centric environment? If so, the Product Champion Director role at AstraZeneca could be an excellent fit for you!

About the GTO Team:

In Biologics Global Technical Operations (GTO), we collaborate closely with AstraZeneca’s manufacturing network (internal sites and external partners), R&D, Quality, Regulatory, Supply Chain, and Commercial teams. Our mission is to provide technical leadership, ensuring the delivery of quality products to patients and supporting our product pipeline. The Product Champion serves as the technical lead for assigned product(s) throughout their lifecycle.

What you’ll do:

• Lead a multidisciplinary, cross-functional CMC team to commercialize pipeline and manage commercial products.

• Drive innovation with partners to help AZ Global Biologics achieve its Bold 2030 ambition.

• Collaborate with Biopharmaceutical Development (BPD) to shape future commercial processes, acting as the Biologic Operations lead in early and mid-phase development teams.

• Build and support a reliable team capable of handling complex issues with appropriate actions.

• Deliver year-over-year improvements in yield and cost of goods, meeting patient and business needs.

• Lead BLA reviews, respond to health authority questions, and manage post-approval regulatory filings.

• Oversee the implementation of new technologies and methods and conduct research for new knowledge within your expertise.

• Drive forward-looking science and technology visions, developing proposals for improved practices and providing expert technical direction.

• Train staff on new methodologies and technologies and decide or contribute to decisions on resource investments.

• Work across regions and skill groups, advising senior management on project-related issues and future strategies.

• Maintain and share up-to-date knowledge of technical advances within your expertise, ensuring compliance with Safety, Health & Environment (SHE) standards.

Minimum Qualifications:

• Master's degree with 8 years, or bachelor’s degree in engineering or a scientific field with 13 years of experience in biopharmaceutical manufacturing, development, or process engineering.

• Extensive technical knowledge of commercial biologics manufacturing.

• Broad understanding of Operations, including Manufacturing, Supply Chain, Quality Assurance, and Quality Control.

• Excellent communication and influencing skills across all levels and functions.

• Proven ability to lead a diverse matrix team in a complex, global environment.

• Strong technical writing and statistical analysis skills.

• Master’s degree or equivalent professional qualification; knowledge of the drug discovery and development process; understanding of SHE standards and relevant patent/IP strategies.

Desirable:

• PhD in a scientific field or equivalent qualification.

• Proven ability to lead teams.