Associate Project Manager/Project Manager -CMC

About AstraZeneca in Gaithersburg, MD :

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC.

This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science.

We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy.

This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.

Summary of the group :

Biopharmaceutical Development (BPD) develops the broad range of scientifically-advanced, high-quality processes and methodologies required for the manufacture and supply of clinical products across the AstraZeneca’s biologics portfolio.

CMC Project Management function with BPD plays a critical role in advancement of projects in the pipeline by strategic CMC leadership and coordination of in / out-licensing activities.

The Associate Project Manager (APM) / Project Manager (PM) works collaboratively with CMC Team Leaders and CMC Teams to ensure Biopharmaceutical Development (BPD) project goals and milestones are achieved by providing project management expertise to CMC Teams ensuring smooth and efficient operational implementation of CMC strategy, and enabling project delivery in line with time, financial and quality requirements.

The APM / PM may also contribute to departmental or functional initiatives or projects. This role has a moderate job complexity and the successful candidate must have a high level of independence to meet requirements outlined below with minimal supervision.

Main Duties & Responsibilities :

• Ensures effective integration of science and project objectives. Manages BPD activities for specified projects, interfacing with relevant functional groups, and with external suppliers as necessary, to plan and coordinate the timely execution of CMC activities and contingencies.
• Leads and facilitates CMC Team meetings and is responsible for project logistics and documentation. Ensures key project management tools are used appropriately to enhance project delivery and information dissemination to the business.
• Responsible for the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
• Interfaces internally and externally as required in evaluation of clinical and nonclinical material demand and to provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.
• Enables communications to align project activities with GPT strategy, including planning of any necessary changes to the CMC deliverables, and aiding activities to secure GPT (Global Project Team) and BPD Leadership Team support.
• Collaborates with BPD functional representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects.
• Communicates effectively with BPD, GPPM (Global Project & Portfolio Management), and with all interfacing functions and relevant governance bodies as required.

In addition to the above requirements, a Project Manager will also be responsible for :

• Influences, develops, maintains, owns and deploys key project management tools. Ensure tools are used appropriately to enhance project delivery and information dissemination to the business.
• Ensures the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
• Anticipates operational issues at the project level, and, working within the cross-project community, to influence solutions for similar issues in other projects

Education & Experience Requirements :

• Bachelor's, Master's, or equivalent industry experience in a relevant technical discipline such as Biochemistry, Molecular Biology, Microbiology, Genetics, Immunology or Chemical Engineering.
• For Associate Project Manager : 1 year of Project Management experience (preferably in CMC) is preferred / for Project manager : 1+ years of project manager experience (preferable in CMC) is required.

Required Skills :

• Understanding of biologics CMC development and manufacturing.
• Successful candidate must have experience in planning and managing the cross functional aspects of biopharmaceutical product development.
• The candidate will have demonstrated knowledge and application of Project Management tools, such as Risk Management.
• This position requires a high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.
• Effective working knowledge relevant to management of the technical disciplines represented within the CMC team is expected.
• Comfortable with ambiguity. Must be professional, dedicated, and detail-orientated.
• Excellent oral and written communication, interpersonal, analytical, and computer skills.
• Effective problem solving and analytical skills to tackle and manage a broad range of issues and projects and deliver innovative solutions
• Highly organized and able to work independently on multiple tasks in a fast-paced environment.

Desired Skills :

• Ability to understand scientific data.
• Hands on experience working in one of the CMC Functions
• Familiarity with Planisware 5 (PLANIT) or other project & portfolio management system is preferred.
• Project Management Professional (PMP) or equivalent certification
• Relevant training (PMP or equivalent) or experience in project management is preferred.

Why AstraZeneca?

So, what’s next!

Where can I find out more?

Check out our landing page for more information on our BPD group

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Date Posted

20-Jun-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.

We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments / accommodations to help all candidates to perform at their best.

If you have a need for any adjustments / accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.