Operations Director jobs in Waldorf, MD

Introduction to role:

Join us in a cross-functional leadership role within the Global Technical Operations (GTO) team, focusing on the strategic planning and coordination of technical leadership for our radioconjugate platforms. This role is a unique opportunity to make an impact on society through our sustainability goals and be a key contributor to Zero Carbon by 2025 and carbon negative across the entire value chain by 2030.

Accountabilities:

As the GTO New Modalities and Technology Director, you will act as the early MS&T and platform owner for RadioConjugates and Radioligands, leading Operations engagement with various development technical and leadership teams. You will establish and lead Operations standard work, drive harmonized processes for commercializing platforms for Radio conjugates, and act as the Subject Matter Expert for site engineering efforts. You will also consult on aseptic fill, formulation and lyophilization development, process design and validation, and coordinate partnership of GTO team with Regulatory, Quality Assurance, and CMC teams.

Essential Skills/Experience:

• Bachelor's degree and eight plus years of experience is required.

• Extensive knowledge of critically relevant areas such as analytical characterization, formulation, and the general CMC scope for RadioConjugates.

• Experience in a Commercial/late stage manufacturing setting

• Proven history of regulatory document authoring or regulatory technical strategy development

• Bachelor of Science with 10 Years of experience in biologics manufacturing; 7 years with advanced degree

• The ability to co-create and collaborate in complex and agile environments

• Ability to advance projects against accelerated timelines, clearly define go/no go decisions points, with a focus on execution.

• Experience with Project Management (budgeting, timelines, resourcing, planning).

• Excellent communication skills, highly effective in interacting with key internal and external stakeholders.

• Strong organizational and coaching skills.

Desirable Skills/Experience:

• Master's degree preferred.

• Late phase/commercial experience in resin evaluation, selection and platformization, including resin selection experimental design

• Facility engineering, commissioning and qualification experience

• Aseptic fill finish characterization and validation

• Lyophilization characterization and validation experience

• Demonstrated leadership in expedited yet thorough evaluation of emerging technology

• Ability in influence and balance the interests of multiple stakeholders while ensuring results

• Proficiency with PowerBI, PowerAutomate and Microsoft Office suite of tools

• Understanding and competency in DoE study design

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We are part of an inclusive and giving community where we support each other on our journeys. We are disciplined thinkers and doers who thrive in our often intense and ambiguous environment. We are leading the way in delivering Lean processes that drive greater efficiency and speed. Sustainable practices are at the heart of what we do, ensuring we manage our environmental impact across all our activities and products.

Are you ready to make a difference? Join us in our mission to deliver more medicines to patients, quicker and more affordably. Apply today!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.